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

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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.


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 weeks before study treatment

- 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)
We found this trial at
31
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Germantown, Tennessee 38138
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Abilene, Texas 79606
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Albany, New York 12206
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Boston, Massachusetts 02115
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Dallas, Texas 75246
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15681 New Hampshire Court
Fort Myers, Florida 33901
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Houston, Texas 77030
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2021 North MacArthur Boulevard
Irving, Texas 75063
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3322 West End Avenue
Nashville, Tennessee 37203
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719 Thompson Lane
Nashville, Tennessee 37204
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Nashville, Tennessee 37212
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Oklahoma City, Oklahoma 73104
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101 The City Drive South
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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2410 Round Rock Avenue
Round Rock, Texas 78681
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4501 X St
Sacramento, California 95817
(916) 734-5800
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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3838 California Street
San Francisco, California 94118
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Sarasota, Florida 34232
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10510 North 92nd Street
Scottsdale, Arizona 85258
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Spokane, Washington 99218
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Tucson, Arizona 85724
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910 East Houston Street
Tyler, Texas 75702
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Vancouver, Washington 98684
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2811 Tieton Drive
Yakima, Washington 98902
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