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NCT01177397 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma
A Phase 1 study of Non-Small Cell Lung Cancer and Multiple Myeloma, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 226
- Enrollment target
- 16
- Study locations
NCT01177397: Completed Phase 1 study of Non-Small Cell Lung Cancer and Multiple Myeloma, sponsored by Celgene.
NCT01177397 is a Phase 1 study of Non-Small Cell Lung Cancer and Multiple Myeloma that has completed, run by Celgene. The registered enrollment target is 226 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (65% lower). The trial reports 16 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01177397, a Phase 1 study of Non-Small Cell Lung Cancer and Multiple Myeloma, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 226 participants
- Enrollment target
- 16
- Study locations
Study Summary
The main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor type for later-stage clinical trials.
Primary Outcome
A dose-limiting toxicity was defined as: - ≥ Grade 3 (per Common Terminology Criteria for Adverse Events \[CTCAE\] Version 4) clinically relevant adverse event (AE) or laboratory abnormality suspected to be related to CC-223 that commenced within 30 days of first dose, except alopecia, Grade 3 rash of the acneiform or maculopapular type for \< 5 days, Grade 3 diarrhea or vomiting lasting \< 72 hours, repeated occurrence of Grade 3 hyperuricaemia in subjects with Grade 3 hyperuricemia at baseline
Conditions Studied
Interventions
- DRUG CC-223
Study Locations (16)
Other
- Institut Claudius Regaud - Toulouse
- Institut Gustave Roussy Faculte de Medecine Paris Sud Service de pneumologie - Villejuif
- Hospital Universitario de Salamanca - Salamanca
- Hospital Universitario Virgen Del Rocio - Seville
- Sarah Cannon Research Institute UK - London
- UCL Cancer Institute - London
California
- Cedars-Sinai Medical Center - Los Angeles
- UCLA Neuro-Oncology Program - Los Angeles
- University of California, San Francisco Hellen Diller Family Comprehensive Cancer Center - San Francisco
Florida
- Moffitt Cancer Center - Tampa
Minnesota
- Mayo Clinic Cancer Clinical Studies Unit - Rochester
Montana
- Billings Clinic - Billings
New Jersey
- Hackensack University Medical Center - Hackensack
New York
- NYU Cancer Institute - Bellevue Hospital - New York
Tennessee
- Sarah Cannon Research Institute Drug Development Unit - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2010-07-20 |
| Est. Completion | 2016-12-09 |
| Phase | Phase 1 |
What the finished NCT01177397 record still lists
NCT01177397 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (65% lower).
The record links to 7 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which CC-223 is the first listed.
NCT01177397 lists 16 locations in 9 states (Other, California, Florida).
Frequently Asked Questions
What is clinical trial NCT01177397 about?
NCT01177397 is a clinical study titled "Study to Assess Safety, Pharmacokinetics, and Efficacy of Oral CC-223 for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma". The main purpose of this first human study with CC-223 is to assess the safety and action of a new class of experimental drug (dual mTOR inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor type for later-stage clinical trial...
What is the current status of trial NCT01177397?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 226 participants. The study started on 2010-07-20. Estimated completion is 2016-12-09.
What conditions does trial NCT01177397 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Multiple Myeloma, Hepatocellular Carcinoma, Diffuse Large B Cell Lymphoma, Glioblastoma Multiforme.
What interventions are being tested in trial NCT01177397?
The interventions under investigation include: CC-223 (DRUG).
Who is sponsoring clinical trial NCT01177397?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01177397 being conducted?
This trial has 16 study locations across California, Florida, Minnesota, Montana, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01177397's enrollment target sits among peer trials
226 156th of 454 higher than 299 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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