Ovarian Cancer Clinical Trial
Palbociclib and Binimetinib in RAS-Mutant Cancers, A ComboMATCH Treatment Trial
Summary
This phase II clinical trial evaluates the effectiveness of palbociclib and binimetinib in treating patients with RAS-mutated cancers. Palbociclib and binimetinib are both in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals cancer cells to multiply. This trial may help researchers understand if giving the combination of palbociclib and binimetinib can help improve the amount of time before the cancer grows in patients with patients with low grade serous ovarian cancer who have certain changes in the tumor DNA. This trial may also help researchers understand if giving the combination of palbociclib and binimetinib can help improve outcomes among patients with low grade serous ovarian cancer who have previously received a MEK inhibitor. For patients with other tumors, with the exception of lung cancer, colon cancer, melanoma and low grade serous ovarian cancers, this trial may help researchers understand if giving the combination of palbociclib and binimetinib can improve the clinical outcome of survival without progression in patients who have certain changes in their tumor's DNA.
Full Description
PRIMARY OBJECTIVES:
I. To determine whether palbociclib and binimetinib combination therapy improves progression free survival (PFS) compared to binimetinib alone in patients with MEK-inhibitor naive low-grade serous ovarian cancer (LGSOC) harboring MAP kinase activation (KRAS/NRAS/non BRAF V600E mutation). (Cohort 1) II. To determine whether palbociclib and binimetinib improves clinical activity in comparison to historical control, as measured by objective response rate (ORR), in women with LGSOC whose disease has previously progressed on a MEK inhibitor. (Cohort 2) III. To determine whether palbociclib and binimetinib combination therapy improves the objective response rate compared to historical control in patients with pancreatic cancer harboring any KRAS/NRAS/HRAS mutation or non-BRAF V600E aMOIs or rare RAF fusion. (Cohort 3) IV. To determine whether palbociclib and binimetinib combination therapy improves objective response rate compared to historical control in patients with tumors harboring any KRAS/NRAS/HRAS mutations or non-BRAF V600E aMOIs or rare RAF fusions (excluding LGSOC, non-small cell lung cancer [NSCLC], colorectal cancer, pancreatic cancer and melanoma). (Cohort 4)
SECONDARY OBJECTIVES:
I. To determine whether palbociclib and binimetinib combination therapy improves objective response rate (ORR), overall survival (OS), duration of response (DOR), and disease control rate (DCR) compared to binimetinib alone in patients with MEK inhibitor-naïve LGSOC. (Cohort 1) II. Conduct whole-exome sequencing to evaluate concordance with the designated laboratory result. (Cohort 1) III. To assess the clinical activity of palbociclib and binimetinib as measured by PFS, OS, DOR, and DCR in women with LGSOC whose disease has previously progressed on a MEK inhibitor. (Cohort 2) IV. Conduct whole-exome sequencing to evaluate concordance with the designated laboratory result. (Cohort 2) V. To assess the clinical activity of palbociclib and binimetinib as measured by PFS, OS, DOR, and DCR in patients with RAS mutated pancreatic cancer. (Cohort 3) VI. Conduct whole-exome sequencing to evaluate concordance with the designated laboratory result. (Cohort 3) VII. To assess the clinical activity of palbociclib and binimetinib as measured by PFS, OS, DOR, and DCR in patients with RAS mutated cancers, excluding LGSOC, NSCLC, colorectal cancer (CRC), pancreatic cancer and melanoma. (Cohort 4) VIII. Conduct whole-exome sequencing to evaluate concordance with the designated laboratory result. (Cohort 4)
EXPLORATORY OBJECTIVES:
I. Explore thymidine kinase 1 (TK1) activity in response to palbociclib. (Cohort 1) II. Assess the correlation between presence of KRAS mutation and activity of both monotherapy and the combination. (Cohort 1) III. Conduct ribonucleic acid (RNA)-sequencing (seq) to assess determinants of response and resistance. (Cohort 1) IV. Explore changes in plasma RAS allelic burden in KRAS-mutated tumors using circulating tumor deoxyribonucleic acid (ctDNA) and correlate changes with clinical activity. (Cohort 1) V. Explore TK1 activity in response to palbociclib.(Cohort 2) VI. Assess the correlation between presence of KRAS mutation and activity of the combination. (Cohort 2) VII. Conduct RNA-seq to assess determinants of response and resistance. (Cohort 2) VIII. Explore changes in plasma RAS allelic burden in KRAS-mutated tumors using ctDNA and correlate changes with clinical activity. (Cohort 2) IX. Explore TK1 activity in response to palbociclib. (Cohort 3) X. Evaluate changes in deoxyribonucleic acid (DNA), RNA and ctDNA to evaluate concordance with the designated laboratory result and to assess determinants of response, signatures of intrinsic resistance or response and the plasma RAS allelic burden in relation to treatment response, respectively. (Cohort 3) XI. Explore TK1 activity in response to palbociclib. (Cohort 4) XII. Evaluate changes in DNA, RNA and ctDNA to evaluate concordance with the designated laboratory result and to assess determinants of response, signatures of intrinsic resistance or response and the plasma RAS allelic burden in relation to treatment response, respectively. (Cohort 4)
OUTLINE: Patients with KRAS, NRAS, non-BRAF V600E aMOIs or rare RAF fusions LGSOC, naïve to MEK or CDK4/6 inhibitor therapy are randomized to either combination cohort 1 or monotherapy cohort 1. Patients with LGSOC who have received prior MEK inhibitor therapy are assigned to combination cohort 2. Patients with KRAS/NRAS/HRAS/non-V600E a MOIs or rare RAF fusion pancreatic cancer are assigned to combination cohort 3. Patients with all other KRAS/NRAS/HRAS, non -BRAF V600E a MOIs or rare FAR fusion tumor types (excluding LGSOC, NSCLC, CRC, pancreatic, and melanoma) are assigned to combination cohort 4.
COMBINATION COHORTS 1, 2, 3, 4: Patients receive palbociclib orally (PO), once per day (QD) on days 1-21 and binimetinib PO twice per day (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity for up to 3 years. Patients may also undergo biopsy at screening and undergo magnetic resonance imaging (MRI), computed tomography (CT), bone scan, and collection of blood samples during screening, on study, and/or during follow up.
MONOTHERAPY COHORT 1: Patients receive binimetinib PO BID daily, in the absence of disease progression or unacceptable toxicity, for up to 3 years. Patients who experience disease progression may elect to migrate to the combination cohort. Patients may also undergo biopsy at screening and undergo MRI, CT, bone scan, and collection of blood samples during screening, on study, and/or during follow up.
After completion of study treatment, patients are followed up every 3 months for up to 3 years following registration.
Eligibility Criteria
Inclusion Criteria:
GENERAL ComboMATCH EAY191 REGISTRATION INCLUSION CRITERIA:
Patients must be enrolled on the EAY191 registration study and be assigned to this protocol by EAY191
Patients must have KRAS/NRAS/HRAS or BRAF alterations RAF mutations or RAF fusions as determined by the ComboMATCH screening assessment
Patients with low grade serous ovarian cancer who have progressed on a prior MEK inhibitor are not required to have a KRAS/NRAS/HRAS or BRAF alteration
Patients must not have a BRAF V600E alteration as determined by the ComboMATCH screening assessment
Patients with a tumor harboring KRAS G12C mutation will be eligible either after they have received a G12C inhibitor or can be enrolled if they do not meet eligibility for a G12C inhibitor. However, patients with tumors harboring KRAS G12C mutation will be prioritized for a G12C inhibitor-based substudy if eligible
Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have archival tissue available from within 12 months prior to registration
Please note the current actionable marker of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website: www.ctsu.org (final URL pending)
EAY191-A3 IELIGIBILITY CRITERIA:
Histologically confirmed cancer for each cohort for which curable treatment modalities are not an option. Rare BRAF fusions and non-BRAF V600E aMOIs are acceptable
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. There is a mandatory baseline biopsy for all ComboMATCH studies. Hence, patient must have a biopsiable lesion at baseline. Of note, in the case when a baseline biopsy is done after scans are obtained, a lesion separate from one that is biopsied needs to be measurable per RECIST 1.1. All radiologic studies must be performed within 28 days prior to randomization
COHORT 1: Low grade serous ovarian cancer with KRAS, NRAS non-BRAF V600E aMOIs or rare RAF fusions are acceptable
COHORT 1: No prior MEK inhibitor or CDK4/6 inhibitor therapy
COHORT 1: Any number of prior therapies permitted
COHORT 1: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks of the first dose of study therapy
COHORT 1: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to the start of study treatment
COHORT 2: Low grade serous ovarian cancer
COHORT 2: Prior progression of disease on a MEK inhibitor (prior binimetinib permitted)
COHORT 2: If patient has previously received binimetinib, they cannot have required dose reduction or discontinuation of binimetinib due to adverse events
COHORT 2: No prior receipt of a CDK4/6 inhibitor
COHORT 2: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks of the first dose of study therapy
COHORT 2: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to the start of study treatment. Patients migrating from cohort 1 may have received binimetinib within 28 days of registering to cohort 2
COHORT 3: Pancreatic cancer with KRAS/NRAS/HRAS, non-BRAF V600E aMOIs or rare RAF fusions are acceptable
COHORT 3: No prior MEK inhibitor (MEKi) and CDK4/6i therapy
COHORT 3: Progression after at least one line of prior therapy as long as there is no standard therapy available or acceptable to patients that is thought to be of benefit
COHORT 3: Any number of prior therapies are permitted
COHORT 3: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks of the first dose of study therapy
COHORT 3: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to the start of study treatment
COHORT 4: KRAS/NRAS/HRAS non-BRAF V600E aMOIs or rare RAF fusions are acceptable
COHORT 4: No prior MEKi and CDK4/6i therapy and progression after at least one line of prior therapy, as long as there is no standard therapy available or acceptable to patients that is thought to be of benefit
COHORT 4: Any number of prior therapies are permitted
COHORT 4: No more than 6 patients with a given tumor type allowed in this cohort
COHORT 4: Any tumor type, except: LGSOC/NSCLC/CRC/pancreatic/melanoma
COHORT 4: No major surgery within 4 weeks (excluding placement of vascular access), minor surgery within 2 weeks, or palliative radiotherapy within 2 weeks of the first dose of study therapy
COHORT 4: No prior cancer-directed therapy within 28 days prior to registration. Patients may have received cancer-directed hormonal therapy up to 14 days prior to the start of study treatment
Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required
Age >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status < 2
Absolute neutrophil count (ANC) >= 1,500/mm^3
Platelet count >= 100,000/mm^3
Hemoglobin > 9 g/dL
Creatinine =< 1.5 x upper limit of normal (ULN) or calculated (calc.) creatinine clearance >= 30 mL/min as calculated by the Cockcroft-Gault formula
Total bilirubin =< 1.5 x upper limit of normal (ULN). Patients with Gilbert syndrome may enroll if total bilirubin (bili) < 3 mg/dL (51 micromole/L)
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
Creatine phosphokinase (CPK) =< 2.5 x ULN
Patients must be able to swallow oral formulations of the agents
No history of interstitial lung disease. No history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Patients should not have history of bowel perforation or intestinal fistulas in the last 6 months
No patients with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or active inflammatory bowel disease
No active skin disorder that has required systemic therapy within the past 1 year
No history of rhabdomyolysis
No concurrent ocular disorders including:
Subjects with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes
Subject with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure > 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO
Subjects with a history of corneal erosion (instability of corneal epithelium), corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions
No patients with a history of hypersensitivity to any of the study drug(s)
No prior allogeneic stem cell or solid organ transplantation
Central nervous system (CNS) metastases must have been treated with local therapy (surgery, radiation, ablation) and patient off of systemic steroids, and brain metastases stable for at least 1 month
No residual Common Terminology Criteria for Adverse Events (CTCAE) >= grade 2 toxicity from any prior anticancer therapy, with the exception of grade 2 alopecia or grade 2 neuropathy
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Patients whose left ventricular ejection fraction (LVEF) has been evaluated by echocardiography (ECHO)/multigated acquisition scan (MUGA) are excluded if the most recent exam shows an LVEF < 50%
Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study
Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
No exposure to P-glycoprotein (P-gp) inhibitors or inducers within 14 days prior to the first dose and during the course of therapy
Patients treated with Cohort 1 control treatment binimetinib who experience disease progression may elect to migrate to cohort 2 and receive combination treatment with palbociclib and binimetinib. Patients who choose to do so must meet laboratory values and performance status requirements as above and must be begin treatment within 21 days
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There are 136 Locations for this study
Birmingham Alabama, 35233, United States More Info
Principal Investigator
Mobile Alabama, 36688, United States More Info
Principal Investigator
Boise Idaho, 83706, United States
Caldwell Idaho, 83605, United States
Coeur d'Alene Idaho, 83814, United States More Info
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Nampa Idaho, 83687, United States
Post Falls Idaho, 83854, United States More Info
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Sandpoint Idaho, 83864, United States More Info
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Bloomington Illinois, 61704, United States More Info
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Canton Illinois, 61520, United States More Info
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Carthage Illinois, 62321, United States More Info
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Chicago Illinois, 60611, United States More Info
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Chicago Illinois, 60612, United States More Info
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Chicago Illinois, 60637, United States More Info
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Danville Illinois, 61832, United States More Info
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Decatur Illinois, 62526, United States More Info
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Decatur Illinois, 62526, United States More Info
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DeKalb Illinois, 60115, United States More Info
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Dixon Illinois, 61021, United States More Info
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Effingham Illinois, 62401, United States More Info
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Effingham Illinois, 62401, United States More Info
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Eureka Illinois, 61530, United States More Info
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Galesburg Illinois, 61401, United States More Info
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Geneva Illinois, 60134, United States More Info
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Glenview Illinois, 60026, United States More Info
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Grayslake Illinois, 60030, United States More Info
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Kewanee Illinois, 61443, United States More Info
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Lake Forest Illinois, 60045, United States More Info
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Macomb Illinois, 61455, United States More Info
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Mattoon Illinois, 61938, United States More Info
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New Lenox Illinois, 60451, United States More Info
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O'Fallon Illinois, 62269, United States More Info
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Orland Park Illinois, 60462, United States More Info
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Orland Park Illinois, 60462, United States More Info
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Ottawa Illinois, 61350, United States More Info
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Pekin Illinois, 61554, United States More Info
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Peoria Illinois, 61615, United States More Info
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Peru Illinois, 61354, United States More Info
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Princeton Illinois, 61356, United States More Info
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Springfield Illinois, 62702, United States More Info
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Springfield Illinois, 62702, United States More Info
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Springfield Illinois, 62781, United States More Info
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Urbana Illinois, 61801, United States More Info
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Warrenville Illinois, 60555, United States More Info
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Washington Illinois, 61571, United States More Info
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Ankeny Iowa, 50023, United States More Info
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Des Moines Iowa, 50309, United States More Info
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Augusta Maine, 04330, United States More Info
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Brewer Maine, 04412, United States More Info
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Scarborough Maine, 04074, United States More Info
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South Portland Maine, 04106, United States More Info
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Ann Arbor Michigan, 48106, United States More Info
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Battle Creek Michigan, 49017, United States More Info
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Brighton Michigan, 48114, United States More Info
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Brighton Michigan, 48114, United States More Info
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Canton Michigan, 48188, United States More Info
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Canton Michigan, 48188, United States More Info
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Chelsea Michigan, 48118, United States More Info
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Chelsea Michigan, 48118, United States More Info
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Dearborn Michigan, 48124, United States More Info
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Farmington Hills Michigan, 48336, United States More Info
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Flint Michigan, 48503, United States More Info
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Flint Michigan, 48503, United States More Info
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Flint Michigan, 48503, United States More Info
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Flint Michigan, 48503, United States More Info
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Grand Rapids Michigan, 49503, United States More Info
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Grand Rapids Michigan, 49503, United States More Info
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Kalamazoo Michigan, 49007, United States More Info
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Kalamazoo Michigan, 49007, United States More Info
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Kalamazoo Michigan, 49009, United States More Info
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Lansing Michigan, 48912, United States More Info
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Livonia Michigan, 48154, United States More Info
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Muskegon Michigan, 49444, United States More Info
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Niles Michigan, 49120, United States More Info
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Norton Shores Michigan, 49444, United States More Info
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Pontiac Michigan, 48341, United States More Info
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Pontiac Michigan, 48341, United States More Info
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Reed City Michigan, 49677, United States More Info
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Royal Oak Michigan, 48073, United States More Info
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Saint Joseph Michigan, 49085, United States More Info
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Saint Joseph Michigan, 49085, United States More Info
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Traverse City Michigan, 49684, United States More Info
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Troy Michigan, 48085, United States More Info
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Wyoming Michigan, 49519, United States More Info
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Ypsilanti Michigan, 48106, United States More Info
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Ypsilanti Michigan, 48197, United States More Info
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Bemidji Minnesota, 56601, United States More Info
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Deer River Minnesota, 56636, United States More Info
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Duluth Minnesota, 55805, United States More Info
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Hibbing Minnesota, 55746, United States More Info
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Sandstone Minnesota, 55072, United States More Info
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Virginia Minnesota, 55792, United States More Info
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Cape Girardeau Missouri, 63703, United States More Info
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Creve Coeur Missouri, 63141, United States More Info
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Farmington Missouri, 63640, United States More Info
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Saint Louis Missouri, 63110, United States More Info
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Saint Louis Missouri, 63129, United States More Info
Principal Investigator
Saint Louis Missouri, 63131, United States More Info
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Saint Louis Missouri, 63136, United States More Info
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Saint Peters Missouri, 63376, United States More Info
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Sainte Genevieve Missouri, 63670, United States More Info
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Sullivan Missouri, 63080, United States More Info
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Sunset Hills Missouri, 63127, United States More Info
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Anaconda Montana, 59711, United States More Info
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Billings Montana, 59101, United States More Info
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Bozeman Montana, 59715, United States More Info
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Great Falls Montana, 59405, United States More Info
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Kalispell Montana, 59901, United States More Info
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Missoula Montana, 59804, United States More Info
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Albuquerque New Mexico, 87102, United States More Info
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Buffalo New York, 14263, United States More Info
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New York New York, 10029, United States More Info
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Bismarck North Dakota, 58501, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Fargo North Dakota, 58122, United States More Info
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Centerville Ohio, 45459, United States More Info
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Columbus Ohio, 43214, United States More Info
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Columbus Ohio, 43214, United States More Info
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Columbus Ohio, 43215, United States More Info
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Columbus Ohio, 43228, United States More Info
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Dayton Ohio, 45409, United States More Info
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Dayton Ohio, 45409, United States More Info
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Dayton Ohio, 45415, United States More Info
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Delaware Ohio, 43015, United States More Info
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Delaware Ohio, 43015, United States More Info
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Dublin Ohio, 43016, United States More Info
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Dublin Ohio, 43016, United States More Info
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Franklin Ohio, 45005, United States More Info
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Greenville Ohio, 45331, United States More Info
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Mansfield Ohio, 44903, United States More Info
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Marion Ohio, 43302, United States More Info
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Troy Ohio, 45373, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
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Newberg Oregon, 97132, United States More Info
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Ontario Oregon, 97914, United States
Oregon City Oregon, 97045, United States More Info
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Portland Oregon, 97213, United States More Info
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Portland Oregon, 97225, United States More Info
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Bryn Mawr Pennsylvania, 19010, United States More Info
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Media Pennsylvania, 19063, United States More Info
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Paoli Pennsylvania, 19301, United States More Info
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Wynnewood Pennsylvania, 19096, United States More Info
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Greenville South Carolina, 29605, United States More Info
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Sioux Falls South Dakota, 57104, United States More Info
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Sioux Falls South Dakota, 57117, United States More Info
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Abilene Texas, 79601, United States More Info
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Houston Texas, 77030, United States More Info
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Fairfax Virginia, 22031, United States More Info
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Falls Church Virginia, 22042, United States More Info
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Edmonds Washington, 98026, United States More Info
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Issaquah Washington, 98029, United States More Info
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Seattle Washington, 98122, United States More Info
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Morgantown West Virginia, 26506, United States More Info
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Appleton Wisconsin, 54911, United States More Info
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Ashland Wisconsin, 54806, United States More Info
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La Crosse Wisconsin, 54601, United States More Info
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Stevens Point Wisconsin, 54482, United States More Info
Principal Investigator
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