Trials / Completed
CompletedNCT01353625
Study to Assess Safety and Tolerability of Oral CC-115 for Patients With Advanced Solid Tumors, and Hematologic Malignancies.
A Phase 1a/1b, Multicenter, Open Label, Dosefinding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the Dual Dna-pk and Tor Kinase Inhibitor, Cc-115, Administered Orally to Subjects With Advanced Solid Tumors and Hematologic Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 118 (actual)
- Sponsor
- Celgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this first human study with CC-115 is to assess the safety and action of a new class of experimental drug (dual DNA-PK and TOR kinase inhibitors) in patients with advanced tumors unresponsive to standard therapies and to determine the appropriate dose and tumor types for later-stage clinical trials. The bioavailability of tablet and capsule formulations under fasting and fed conditions will also be evaluated in some patients.
Detailed description
Latest amendment clarifies that Chronic Lymophocytic Leukemia (CLL) includes T-cell Prolymphocytic Leukemia (T-PLL). Prior treatment with some drugs targeting mTOR, P13K and related pathways is now permitted.
Conditions
- Glioblastoma Multiforme
- Squamous Cell Carcinoma of Head and Neck
- Prostate Cancer
- Ewing's Osteosarcoma
- Chronic Lymphocytic Leukemia
- Neoplasm Metastasis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CC-115 | Part A (actively recruiting): Dose level starts with 0.5mg daily by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose schedule is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: Optimal dose schedule is administered in 28-day cycles until disease progression. |
Timeline
- Start date
- 2011-04-25
- Primary completion
- 2021-03-12
- Completion
- 2021-03-12
- First posted
- 2011-05-13
- Last updated
- 2021-10-05
Locations
17 sites across 4 countries: United States, France, Germany, Spain
Source: ClinicalTrials.gov record NCT01353625. Inclusion in this directory is not an endorsement.