Myeloproliferative Neoplasms Clinical Trial

A Study of Oral TP-3654 in Patients With Myelofibrosis

Summary

This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of TP-3654 in patients with intermediate or high-risk primary or secondary MF.

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Full Description

This study will enroll patients who have been previously treated and failed on a JAK inhibitor or ineligible to receive ruxolitinib or fedratinib.

View Eligibility Criteria

Eligibility Criteria

Patients must meet all of the following inclusion criteria to be eligible:

Confirmed pathological diagnosis of primary myelofibrosis (PMF) or post-PV-MF/post-ET- MF as per WHO diagnostic criteria and intermediate or high-risk primary or secondary MF based on the Dynamic International Prognostic Scoring System (DIPSS)
Previously treated with a JAK inhibitor and failed on a JAK inhibitor or are ineligible to be treated with Ruxolitinib or Fedratinib at the discretion of the investigator
Grade ≥ 2 bone marrow fibrosis, as confirmed by bone marrow biopsy within 12 weeks prior to Screening

Fulfill the following laboratory parameters:

Platelet count ≥ 25 X 10^9 /L, without the assistance of growth factors or platelet transfusions
Absolute Neutrophil Count (ANC) ≥ 1 x 10^9/L without the assistance of granulocyte growth factors
Peripheral blood blast count < 10%
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Life expectancy ≥ 3 months
Adequate renal function, as determined by clinical laboratory tests (serum creatinine ≤ 1.5 x upper limit of normal (ULN), and calculated creatinine clearance ≥ 30 mL/min) (Cockcroft-Gault)
Adequate hepatic function (ALT/AST ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN; or ALT/AST ≤ 5 x ULN, direct bilirubin ≤ 2 x ULN if due to myelofibrosis), and coagulation ([PT and PTT] ≤ 1.5 x ULN)
Agree to provide bone marrow biopsies during the study: at baseline or within 12 weeks prior to enrollment, and every 6 months during treatment.
Splenomegaly during the screening period as demonstrated by splenic length ≥ 5 cm below the costal margin by palpation or spleen volume of ≥ 450 cm3 by Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) scan
Show at least 2 symptoms measurable (score ≥ 1) using the MF-SAF, v4.0.

Patients meeting any one of these exclusion criteria will be prohibited from participating in this study:

Received previous systemic antineoplastic therapy (including unconjugated therapeutic antibodies, toxin immunoconjugates, ESA, and alpha-interferon) or any experimental therapy within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment.
Major surgery within 2 weeks before the first dose of either study drug.
Splenic irradiation within 6 months prior to Screening or prior splenectomy.
AML, MDS, or peripheral blasts ≥ 10%.
Prior autologous or allogeneic stem cell transplant at any time.
Eligible for allogeneic bone marrow or stem cell transplantation within 3 months following enrollment.
Experiencing electrolyte abnormalities of NCI CTCAE Grade ≥ 2 unless they can be corrected during screening and are deemed not clinically significant by the Investigator.
History of congestive heart failure, myocardial infarction within the past 6 months prior to Cycle 1/Day 1; left ventricular ejection fraction < 45% by echocardiogram or MUGA, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG) within 14 days prior to Cycle 1/Day 1.
Corrected QT interval (using Fridericia's correction formula) of > 450 msec in men and > 470 msec in women.
Central nervous system (CNS) cancer or metastases, meningeal carcinomatosis, malignant seizures, or a disease that either causes or threatens neurologic compromise (eg, unstable vertebral metastases).
Other invasive malignancies within the last 3 years, except non-melanoma skin cancer, and localized cured prostate and cervical cancer
Experienced portal hypertension or any of its complications.
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic antimicrobial within 14 days.
Known bleeding diathesis or signs of uncontrolled active bleeding (hematuria, GI bleeding) other than self-limited causes of benign etiology that have been adequately investigated at the discretion of the Investigator.
Requiring anticoagulation with aspirin > 81mg daily, unfractionated heparin, low molecular weight heparin (LMWH), direct anti-thrombin inhibitors, or vitamin K antagonists (eg, warfarin).
Severe chronic obstructive pulmonary disease with hypoxemia (defined as resting O2 saturation of < 90% breathing room air).
Medical condition or have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption.
Used hydroxyurea or anagrelide within 24 hours prior to the first dose.
Systemic steroid therapy (>10 mg daily prednisone or equivalent) within 7 days prior to the first dose of study treatment (note: topical, inhaled, nasal, and ophthalmic steroids are not prohibited).

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT04176198

Recruitment Status:

Recruiting

Sponsor:

Sumitomo Pharma America, Inc.

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There are 17 Locations for this study

See Locations Near You

University of Alabama
Birmingham Alabama, 35294, United States More Info
Tiffany Hill
Contact
205-934-9591
The University of Arizona Cancer Center
Tucson Arizona, 85724, United States More Info
Audrey Johnson
Contact
520-694-9084
[email protected]
City of Hope
Duarte California, 91010, United States More Info
Michelle Velasquez
Contact
626-218-3524
[email protected]
University of Southern California
Los Angeles California, 90033, United States More Info
Shirley Sian
Contact
323-865-0456
[email protected]
Blood Cancer Center
Denver Colorado, 80218, United States More Info
Brooke Rhodes
Contact
[email protected]
University of Florida Health Shands Cancer Hospital
Gainesville Florida, 32608, United States
University of Miami
Miami Florida, 33136, United States More Info
Alessia Zoso
Contact
305-243-0327
[email protected]
University of Michigan
Ann Arbor Michigan, 48109, United States More Info
Kelsey Bolin
Contact
734-936-2193
[email protected]
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
Jason Brecher
Contact
551-966-5274
[email protected]
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14263, United States More Info
Katherine Collins
Contact
[email protected]
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States More Info
Mikaela Dougherty
Contact
[email protected]
Weill Cornell Medical Center
New York New York, 10065, United States More Info
Penina Steward
Contact
212-746-1858
[email protected]
Duke Cancer Institute
Durham North Carolina, 27710, United States More Info
Ben Dosan
Contact
[email protected]
Tri-Star Centennial Medical Center
Nashville Tennessee, 37203, United States More Info
Brooke Rhodes
Contact
[email protected]
MD Anderson Cancer Center
Houston Texas, 77054, United States More Info
Kurt Schroeder
Contact
713-745-2232
[email protected]
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States More Info
Emerson Lebleu
Contact
801-587-9703
University of Virginia Cancer Center
Charlottesville Virginia, 22903, United States More Info
Kelly Reed
Contact
434-297-7783
[email protected]
Royal Adelaide Hospital
Adelaide South Australia, , Australia More Info
Christine Hoare
Contact
[email protected]
Eastern Health Box Hill Hospital
Box Hill Victoria, , Australia More Info
Liz Arnold
Contact
[email protected]
Icon Cancer Centre (Ashford Cancer Centre Research)
Adelaide , , Australia More Info
Stanley Cheung, MD
Contact
[email protected]
Aichi Medical University Hospital
Aichi , , Japan More Info
Akiyoshi Takami
Contact
0561-62-3311
[email protected]
National Cancer Center Hospital East
Chiba , , Japan More Info
Junichiro Yuda, MD
Contact
04-7133-1111
[email protected]
University of Miyazaki Hospital
Miyazaki , , Japan More Info
Kazuya Shimoda, MD
Contact
0985-85-1510
[email protected]
Osaka University Hospital
Osaka , , Japan More Info
Michiko Ichii, MD
Contact
06-6879-5111
[email protected]
Saitama Medical Center
Saitama , , Japan More Info
Takayuki Tabayashi
Contact
049-228-3411
[email protected]
Shizuoka Cancer Center
Shizuoka , , Japan More Info
Masafumi Fukaya, MD
Contact
055-989-5222
[email protected]
Juntendo University Hospital
Tokyo , , Japan More Info
Shuichi Shirane, MD
Contact
03-3813-3111
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT04176198

Recruitment Status:

Recruiting

Sponsor:


Sumitomo Pharma America, Inc.

How clear is this clinincal trial information?

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