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NCT01862081 · ClinicalTrials.gov registry record · Phase 1
A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT01862081 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 80 participants.
The verdict
NCT01862081, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have HER2-negative locally recurrent or metastatic breast cancer or non-small cell lung cancer (NSCLC). Patients treated with the GDC-0032 and paclitaxel combination have human epidermal growth factor receptor 2 (HER2)-negative locally recurrent or metastatic breast cancer. There are two potential stages within each arm of this study: a dose-escalation stage (Stage 1) and a dose-expansion stage (Stage 2). Once the maximum tolerated dose of GDC-0032 in a given arm has been established from dose escalation, additional patients with each combination will be enrolled in Stage 2.
Interventions
- DRUG Docetaxel
- DRUG Paclitaxel
- DRUG GDC-0032
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2013-07-16 |
| Est. Completion | 2017-06-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01862081
The ClinicalTrials.gov registry entry for NCT01862081 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 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 3 interventions - of which Docetaxel is the first listed.
NCT01862081 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01862081 about?
NCT01862081 is a clinical study titled "A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer". This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0032 administered in combination with either docetaxel or with paclitaxel. Patients treated with the GDC-0032 and docetaxel have HER2-negative locally recurrent or ...
What is the current status of trial NCT01862081?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2013-07-16. Estimated completion is 2017-06-09.
What interventions are being tested in trial NCT01862081?
The interventions under investigation include: Docetaxel (DRUG), Paclitaxel (DRUG), GDC-0032 (DRUG).
Who is sponsoring clinical trial NCT01862081?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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