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
Public ClinicalTrials.gov record NCT01296555. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01296555
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 674 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 16, 2011 (Actual)
- Primary completion
- Jun 25, 2021 (Actual)
- Completion
- Jun 25, 2021 (Actual)
- Last update posted
- Jul 31, 2024
2011 – 2021
United States locations
- U.S. sites
- 27
- U.S. states
- 13
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| TGen Clinical Research Srvs | Scottsdale | Arizona | 85258 | — |
| University of Arizona Cancer Center | Tucson | Arizona | 85719 | — |
| University of California Irvine Medical Center | Orange | California | 92868 | — |
| UC Davis; Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| Sutter Health | San Francisco | California | 94109 | — |
| Yale University | New Haven | Connecticut | 06510 | — |
| Florida Cancer Specialists - Fort Myers (New Hampshire Ct) | Fort Myers | Florida | 33901-8101 | — |
| Sarah Cannon Res Inst; FL | Sarasota | Florida | 34232 | — |
| Univ of Chicago | Chicago | Illinois | 60637 | — |
| Barbara Ann Karmanos Cancer Institute | Detroit | Maine | 48201-2013 | — |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | — |
| Dana Farber Cancer Inst. | Boston | Massachusetts | 02115 | — |
| Washington University; Division of Oncology | St Louis | Missouri | 63110 | — |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| Sarah Cannon Res Inst; OK | Oklahoma City | Oklahoma | 73104 | — |
| West Cancer Center | Germantown | Tennessee | 38138 | — |
| Sarah Cannon Res Inst; TN Onc | Nashville | Tennessee | 37203 | — |
| Vanderbilt Breast Center; Vanderbilt Health Pharmacy | Nashville | Tennessee | 37204 | — |
| Vanderbilt | Nashville | Tennessee | 37232 | — |
| Texas Cancer Center | Abilene | Texas | 79606-5208 | — |
| Mary Crowley Cancer Rsch Ctr | Dallas | Texas | 75230 | — |
| Baylor Sammons Cancer Center | Dallas | Texas | 75246 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| USO - Tyler Cancer Ctr | Tyler | Texas | 75702 | — |
| Northwest Cancer Specialists - Vancouver | Vancouver | Washington | 98684 | — |
| Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington | 98902 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01296555, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 31, 2024 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01296555 live on ClinicalTrials.gov.