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NCT01296555 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Genentech.
- Terminated
- Registry status
- Phase 1
- Development phase
- 674
- Enrollment target
NCT01296555 is a Phase 1 study that was terminated before completion, run by Genentech. The registered enrollment target is 674 participants.
The verdict
NCT01296555, a Phase 1 study, was terminated before completion, sponsored by Genentech.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 674 participants
- Enrollment target
Study 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.
Interventions
- DRUG Letrozole
- DRUG Midazolam
- DRUG Fulvestrant
- DRUG GDC-0032
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 674 participants |
| Start Date | 2011-03-16 |
| Est. Completion | 2021-06-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01296555
The ClinicalTrials.gov registry entry for NCT01296555 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 674 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Letrozole is the first listed.
NCT01296555 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01296555 about?
NCT01296555 is a clinical study titled "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". 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...
What is the current status of trial NCT01296555?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 674 participants. The study started on 2011-03-16. Estimated completion is 2021-06-25.
What interventions are being tested in trial NCT01296555?
The interventions under investigation include: Letrozole (DRUG), Midazolam (DRUG), Fulvestrant (DRUG), GDC-0032 (DRUG).
Who is sponsoring clinical trial NCT01296555?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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