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NCT01235897 · ClinicalTrials.gov registry record · Phase 1
MK-2206, Paclitaxel and Trastuzumab in Treating Patients With HER2-overexpressing Solid Tumor Malignancies
A Phase 1 study of Cancer and Advanced Solid Tumors, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT01235897: Completed Phase 1 study of Cancer and Advanced Solid Tumors, sponsored by University of California, San Francisco.
NCT01235897 is a Phase 1 study of Cancer and Advanced Solid Tumors that has completed, run by University of California, San Francisco. The registered enrollment target is 17 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01235897, a Phase 1 study of Cancer and Advanced Solid Tumors, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to test the safety and safest highest dose of an investigational drug called MK-2206 when given in combination with paclitaxel and trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2)-overexpressing solid tumor malignancies.
Primary Outcome
The MTD was defined as the dose level resulting in 3 or fewer DLTs in 11 patients, per the modified toxicity probability interval (TPI) method (Ji Y, Li Y, Nebiyou Bekele B: Dose-finding in phase I clinical trials based on toxicity probability intervals. Clin Trials 4:235-244, 2007), and confirmed in 4 additional patients. Based on interim toxicity data from other studies, the dose was not escalated beyond 135 mg weekly.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Paclitaxel
- DRUG MK-2206
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT01235897 record still lists
NCT01235897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Cancer appearing as the primary indexed condition, and to 3 interventions - of which Trastuzumab is the first listed.
NCT01235897 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01235897 about?
NCT01235897 is a clinical study titled "MK-2206, Paclitaxel and Trastuzumab in Treating Patients With HER2-overexpressing Solid Tumor Malignancies". The purpose of this study is to test the safety and safest highest dose of an investigational drug called MK-2206 when given in combination with paclitaxel and trastuzumab in patients with Human Epidermal growth factor Receptor 2 (HER2)-overexpressing solid tumor malignancies.
What is the current status of trial NCT01235897?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2011-03. Estimated completion is 2013-11.
What conditions does trial NCT01235897 study?
This clinical trial studies the following conditions: Cancer, Advanced Solid Tumors, Tumors.
What interventions are being tested in trial NCT01235897?
The interventions under investigation include: Trastuzumab (DRUG), Paclitaxel (DRUG), MK-2206 (DRUG).
Who is sponsoring clinical trial NCT01235897?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01235897 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01235897's enrollment target sits among peer trials
17 574th of 615 higher than 36 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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