Study Assessing Safety, Pharmacokinetics and Efficacy of CC-223 With Either Erlotinib or Oral Azacitidine in Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Celgene
Study ID
NCT01545947
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CC-223, erlotinib — DRUG
    Dose escalation: Combination doses start with 15 mg CC-223 and 100 mg erlotinib, or 15 mg CC-223 and 150 mg erlotonib, administered in 28-day cycles. Combination dose levels increase sequentially using predefined regimens until non-tolerated dose levels are established and a maximum tolerated dose combination has been identified for further study. Dose expansion: The maximum tolerated doses are evaluated further for evidence of preliminary efficacy
  • CC-223, oral azacitidine — DRUG
    Dose escalation: Combination doses start with 15 mg CC-223 and 200 mg oral azacitidine, administered in 28-day cycle. Combination dose levels increase sequentially using predefined regimens until non-tolerated dose levels are established and a maximum tolerated dose combination has been identified for further study. Dose expansion: The maximum tolerated doses are evaluated further for evidence of preliminary efficacy
  • CC-223, oral azacitidine — DRUG
    Dose escalation: Sequential dosing starts with 200 mg of oral azacitidine administered on Days 1 through 7 of each 28-day cycle, followed by daily dose level of 15 mg CC-223 on Days 8 through 28. Combination dose levels increase sequentially using predefined regimens until non-tolerated dose levels are established and a maximum tolerated dose combination has been identified for further study. Dose expansion: The maximum tolerated doses are evaluated further for evidence of preliminary efficacy

Study Details

The main purpose of this first study combining an investigational dual mTOR inhibitor, CC-223, with other agents (erlotinib or the investigational agent, oral azacitidine) is to establish a maximum tolerated dose level for each combination in order to evaluate their effects in future clinical trials for advanced non-small cell lung cancer.

Key Dates

First listed
Mar 7, 2012
Start date
May 1, 2012
Status verified
Nov 2019
Primary completion
Dec 11, 2014
Completion
Dec 11, 2014

Study Design

Enrollment
76 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CC-223/erlotinib concurrent
    Cohorts will receive escalating continuous daily doses (15 mg and 30 mg) of CC-223 in capsules concurrently with at least two different daily dose levels of erlotinib tablets (100 mg and 150 mg) in 28-day cycles.
  • Experimental: CC-223/oral azacitidine concurrent
    Cohorts will receive escalating continuous daily doses of CC-223 (15 mg and 30 mg) with one or more dose levels of oral azacitidine (200 mg or 300 mg, as two or three 100 mg tablets) administered on Day 1 to 21 of each 28-day cycle.
  • Experimental: CC-223/oral azacitidine sequential
    Cohorts will receive escalating continuous daily dose levels of CC-223 (15 mg and 30 mg) administered on Days 8 through 28 sequentially with one or more dose levels of of oral azacitidine (200 mg or 300 mg, as two or three 100 mg tablets) administered on Days 1 to 7 of each 28-day cycle

Primary Outcome Measure

Adverse events [ Time Frame: Up to 24 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical Center, Inflammatory Bowel Disease CenterLos AngelesCalifornia90048-
University of California, San FranciscoSan FranciscoCalifornia9411-
NYU School of MedicineNew YorkNew York10016-
Cancer Center of the CarolinasGreenvilleSouth Carolina29605-
Henry-Joyce Cancer ClinicNashvilleTennessee37232-5505-
Mary Crowley Cancer Research Centers - Medical CityDallasTexas75201-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Los Angeles, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Cedars Sinai Medical Center, Inflammatory Bowel Disease Center· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CANYU School of Medicine· New York, NYCancer Center of the Carolinas· Greenville, SCHenry-Joyce Cancer Clinic· Nashville, TNMary Crowley Cancer Research Centers - Medical City· Dallas, TX

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