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NCT01451632 · ClinicalTrials.gov registry record · Phase 1
A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers
A Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Merrimack Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 4
- Study locations
NCT01451632: Completed Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Merrimack Pharmaceuticals.
NCT01451632 is a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer that has completed, run by Merrimack Pharmaceuticals. The registered enrollment target is 48 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (93% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01451632, a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, has completed, sponsored by Merrimack Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study was to evaluate the safety and tolerability of escalating doses of the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.
Primary Outcome
To establish the safety of escalating doses of MM-121 in combination with cetuximab or in combination with cetuximab and irinotecan in order to determine the recommended phase 2 dose.. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.
Conditions Studied
Interventions
- DRUG Cetuximab
- DRUG Irinotecan
- DRUG MM-121
Study Locations (4)
California
- - San Francisco
Massachusetts
- - Boston
North Carolina
- - Chapel Hill
Utah
- - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT01451632 record still lists
NCT01451632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cetuximab is the first listed.
NCT01451632 reports a single indexed study location in California, Massachusetts, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01451632 about?
NCT01451632 is a clinical study titled "A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers". The purpose of this study was to evaluate the safety and tolerability of escalating doses of the MM-121 plus cetuximab and the MM-121 plus cetuximab plus irinotecan combination.
What is the current status of trial NCT01451632?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2011-10. Estimated completion is 2014-06.
What conditions does trial NCT01451632 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Triple Negative Breast Cancer, Squamous Cell Head and Neck Cancer, Other Tumors With EGFR Dependence.
What interventions are being tested in trial NCT01451632?
The interventions under investigation include: Cetuximab (DRUG), Irinotecan (DRUG), MM-121 (DRUG).
Who is sponsoring clinical trial NCT01451632?
This trial is sponsored by Merrimack Pharmaceuticals, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01451632 being conducted?
This trial has 4 study locations across California, Massachusetts, North Carolina, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01451632's enrollment target sits among peer trials
48 337th of 454 higher than 113 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung 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.
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