Breast Cancer Clinical Trial

A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin’s Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Summary

This is an open-label, multicenter, Phase I/II study to assess the safety, tolerability, and pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During Stage 1, GDC-0032 will be administered every day orally and at escalating doses in participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will be administered alone or as combination therapy within indication-specific cohorts. In Phase II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be evaluated in post-menopausal female participants with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Phase I (Cohorts A through D, G, H, T, T2 and X): Histologically documented, locally advanced or metastatic solid malignancy or NHL that has progressed or failed to respond to at least one prior regimen and are not candidates for regimens known to provide clinical benefit
Phase I (Cohorts E and F): Post-menopausal females with locally advanced or metastatic hormone receptor-positive breast cancer that has progressed or failed to respond to at least one prior endocrine therapy in the adjuvant or metastatic setting
Phase I (Cohorts J through S): Post-menopausal females with HER2-negative, hormone-receptor positive breast cancer that has progressed or failed to response to at least one prior endocrine therapy in the adjuvant or metastatic setting
Phase II: Post-menopausal female participants with locally advanced or metastatic HER2-negative, hormone receptor-positive breast cancer
Phase I (Cohorts A through S) and Phase II: Evaluable or measurable disease per RECIST version 1.1
Phase I (Cohorts T, and T2): Greater than or equal to (>/=) 1 bi-dimensionally measurable lesion on computed tomography (CT) scan
Phase I (Cohort T): Participants with non-Hodgkin's lymphoma, regardless of PIK3CA mutation status
Phase 1 (Cohort T2): Participants with diffuse large B-cell lymphoma (DLBCL), regardless of PIK3CA mutation status
Phase I (Cohort X): Participants with PIK3CA-mutant tumors and measurable disease per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at Screening
Life expectancy of >/= 12 weeks
Adequate hematologic and organ function within 28 days prior to initiation of study treatment
Documented willingness to use an effective means of contraception for both men and women while participating in the study

Exclusion Criteria:

Known and untreated, or active central nervous system (CNS) metastases (progressing or requiring treatment)
Active congestive heart failure or ventricular arrhythmia requiring medication
Participants requiring any daily supplemental oxygen
Active inflammatory disease requiring immunosuppressants, including small or large intestinal inflammation such as Crohn's disease or ulcerative colitis
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Treatment with chemotherapy less than or equal to ( Oral endocrine therapy Treatment with investigational drug Treatment with biologic therapy Treatment with kinase inhibitors Radiation therapy (other than radiation to bony metastases) as cancer therapy Palliative radiation therapy to bony metastases Major surgery Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the participant at high risk from treatment complications (examples include but are not limited to clinically significant non-healing wound, active bleeding, or ongoing fistula or active tuberculosis infection)

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

686

Study ID:

NCT01296555

Recruitment Status:

Completed

Sponsor:

Genentech, Inc.

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There are 31 Locations for this study

See Locations Near You

TGen Clinical Research Srvs
Scottsdale Arizona, 85258, United States
University of Arizona Cancer Center
Tucson Arizona, 85719, United States
University of California Irvine Medical Center
Orange California, 92868, United States
UC Davis; Comprehensive Cancer Center
Sacramento California, 95817, United States
Sutter Health
San Francisco California, 94109, United States
Yale University
New Haven Connecticut, 06510, United States
Florida Cancer Specialists - Fort Myers (New Hampshire Ct)
Fort Myers Florida, 33901, United States
Sarah Cannon Res Inst; FL
Sarasota Florida, 34232, United States
Univ of Chicago
Chicago Illinois, 60637, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Dana Farber Cancer Inst.
Boston Massachusetts, 02115, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Washington University; Division of Oncology
Saint Louis Missouri, 63110, United States
New York Oncology Hematology, P.C.
Albany New York, 12206, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10065, United States
Sarah Cannon Res Inst; OK
Oklahoma City Oklahoma, 73104, United States
West Cancer Center
Germantown Tennessee, 38138, United States
Sarah Cannon Res Inst; TN Onc
Nashville Tennessee, 37203, United States
Vanderbilt Breast Center; Vanderbilt Health Pharmacy
Nashville Tennessee, 37204, United States
Vanderbilt
Nashville Tennessee, 37232, United States
Texas Cancer Center
Abilene Texas, 79606, United States
Mary Crowley Cancer Rsch Ctr
Dallas Texas, 75230, United States
Baylor Sammons Cancer Center
Dallas Texas, 75246, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
USO - Tyler Cancer Ctr
Tyler Texas, 75702, United States
Northwest Cancer Specialists - Vancouver
Vancouver Washington, 98684, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima Washington, 98902, United States
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto Ontario, M5G 2, Canada
Institut Gustave Roussy
Villejuif , 94805, France
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona , 08035, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

686

Study ID:

NCT01296555

Recruitment Status:

Completed

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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