Safety and PK Study of CC-90003 in Relapsed/Refractory Solid Tumors

NCT ID: NCT02313012

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-05
• Study Completion Date: 2016-05-03

Brief Summary

The CC-90003-ST -001 trial is a first-in-man, open-label study in subjects with locally-advanced or wide spread cancers to determine if CC-90003 (an oral medication) can be adequately tolerated with minimal side effects.

Detailed Description

CC-90003-ST -001 is an open-label, multicenter, Phase 1a study in subjects with locally-advanced or metastatic, solid tumors who are intolerant of, resistant to, or have relapsed after at least one line of therapy and for whom no standard therapy exists. The study will be conducted in two parts: Dose Escalation (Part 1) and Cohort Expansion (Part 2). Subjects may continue CC-90003 until progression of their underlying malignancy, the occurrence of intolerable toxicity, or physician/subject decision to discontinue CC-90003. In Part 1, cohorts of subjects with relapsed or refractory solid tumors will receive increasing doses of CC-90003 in order to assess its safety and tolerability, the maximum tolerated dose (MTD), and PK profile. In Part 2, cohorts of subjects with specific tumors that harbor mutations involving the Mitogen -Activated Protein Kinase (MAPK) pathway will receive CC-90003 at or below the MTD until progression of disease, intolerable toxicity, or physician/subject decision to discontinue CC-90003.

Conditions

Neoplasm Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Level 1 CC-90003

CC-90003 by mouth (PO) daily on days 1 -21 of every 28 day cycle; Cycle 1, Days 1 to 28 will constitute the dose limiting toxicity (DLT) assessment period for purposes of non-tolerated dose (NTD) and Maximum Tolerated Dose determination.

Group Type: EXPERIMENTAL

CC-90003

Intervention Type: DRUG

CC-90003 PO once daily

Interventions

CC-90003

CC-90003 PO once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Eligible study subjects in Part 1 and Part 2 must be 18 years or older

2. Eligible study subjects must have histologic or cytologic confirmation of advanced, unresectable or metastatic solid tumors, and have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

3. Eligible study subjects must have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1

4. Eligible study subjects must exhibit acceptable liver, bone marrow, renal and cardiac functions as assessed by laboratory tests, ECG and ECHO or MUGA scan.

Exclusion Criteria

1. Subjects with symptomatic or unstable CNS metastases

2. Subjects with a history of recent (within 28 days) systemic therapy for their underlying malignancy

3. Subjects who have had surgery/radiotherapy within 2 weeks prior to start of study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gordon Bray, MD

Role: STUDY_DIRECTOR

Celgene

Locations

Cedars Sinai Medical Center, Inflammatory Bowel Disease Center

Los Angeles, California, United States

Smilow Cancer Center

New Haven, Connecticut, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Peter MacCallum Cancer Centre

Melbourne, , Australia

Countries

United States; Australia

Other Identifiers

CC-90003-ST-001

Identifier Type: -

Identifier Source: org_study_id