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
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer, Cancer, Lymphoma, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/6/2019 |
Start Date: | March 16, 2011 |
End Date: | July 13, 2022 |
An Open-Label, Phase I/II, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer
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.
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.
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 (=) 3 weeks before study treatment
- Oral endocrine therapy = 2 weeks before study treatment
- Treatment with investigational drug = 3 weeks or 5 half-lives before study treatment
- Treatment with biologic therapy = 3 weeks before study treatment
- Treatment with kinase inhibitors = 2 weeks before study treatment
- Radiation therapy (other than radiation to bony metastases) as cancer therapy = 4
weeks before study treatment
- Palliative radiation therapy to bony metastases = 2 weeks before study treatment
- Major surgery = 4 weeks before study treatment
- 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)
We found this trial at
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University of Chicago One of the world's premier academic and research institutions, the University of...
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Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Massachusetts General Hospital Cancer Center An integral part of one of the world
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15681 New Hampshire Court
Fort Myers, Florida 33901
Fort Myers, Florida 33901
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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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101 The City Drive South
Orange, California 92868
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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610 University Avenue
Toronto, Ontario M5G 2M9
Toronto, Ontario M5G 2M9
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