Trials / Completed
CompletedNCT01177397
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 1/2, Multi-Center, Open-Label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Multiple Myeloma
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 226 (actual)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Initially, patients will be treated with oral CC-223 for one month. During this time, various tests (involving blood and urine collections, ECGs, etc) will be performed. Those whose tumors stabilize or regress may continue receiving treatment for as long as they benefit from CC-223. Different dose levels of CC-223 will be tested in a dose-rising study design.
Conditions
- Multiple Myeloma
- Diffuse Large B-Cell Lymphoma
- Glioblastoma Multiforme
- Hepatocellular Carcinoma
- Non-Small Cell Lung Cancer
- Neuroendocrine Tumors of Non-Pancreatic Origin
- Hormone Receptor-Positive Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CC-223 | Part A: (closed to enrollment) Dose level starts with 7.5mg daily taken by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose level is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: (closed to enrollment) Optimal dose is administered in 28 day cycles until disease progression. |
Timeline
- Start date
- 2010-07-20
- Primary completion
- 2016-11-15
- Completion
- 2016-12-09
- First posted
- 2010-08-09
- Last updated
- 2022-12-13
- Results posted
- 2022-11-15
Locations
16 sites across 4 countries: United States, France, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01177397. Inclusion in this directory is not an endorsement.