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COMPLETED 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

NCT01177397 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 226 participants
Start Date 2010-07-20
Est. Completion 2016-12-09
Phase Phase 1

Sponsor

Celgene

73 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01177397

The ClinicalTrials.gov registry entry for NCT01177397 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 226 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 7 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention — of which CC-223 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01177397 reports 16 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Multiple Myeloma, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Glioblastoma Multiforme, Diffuse Large B-Cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01177397?

The interventions under investigation include: CC-223 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01177397?

This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial