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

PHASE1CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

May 1, 2012

Primary Completion Date

December 11, 2014

Study Completion Date

December 11, 2014

Conditions
Carcinoma, Non-Small-Cell LungNon-Small Cell Lung Cancer
Interventions
DRUG

CC-223, erlotinib

"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"

DRUG

CC-223, oral azacitidine

"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"

DRUG

CC-223, oral azacitidine

"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"

Trial Locations (9)

9411

University of California, San Francisco, San Francisco

10016

NYU School of Medicine, New York

29605

Cancer Center of the Carolinas, Greenville

41013

Hospital Virgen del Rocio Servicio de Hematologia, Seville

75201

Mary Crowley Cancer Research Centers - Medical City, Dallas

77030

The University of Texas MD Anderson Cancer Center, Houston

90048

Cedars Sinai Medical Center, Inflammatory Bowel Disease Center, Los Angeles

37232-5505

Henry-Joyce Cancer Clinic, Nashville

08035

Vall d´Hebron University Hospital, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY

NCT01545947 - Study Assessing Safety, Pharmacokinetics and Efficacy of CC-223 With Either Erlotinib or Oral Azacitidine in Advanced Non-Small Cell Lung Cancer | Biotech Hunter | Biotech Hunter