Description:
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.
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.
Terminated
Phase 1
NCT ID: NCT02313012
ORG ID: CC-90003-ST-001
Neoplasm Metastasis
Drug | Synonyms | Arms |
---|---|---|
CC-90003 | Dose Level 1 CC-90003 |
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.
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.
Name | Type | Description | Interventions |
---|---|---|---|
Dose Level 1 CC-90003 | Experimental | 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. | CC-90003 |
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
Maximum Eligible Age: N/A
Eligible Gender: Both
Summary of the adverse events (type, severity, and incidence) related to CC-
Dose Limiting Toxicities of CC-90003
Maximum Tolerated Dose (MTD) of CC-90003
Pharmacokinetics (PK) observed maximum concentration (Cmax)
PK-Area under the plasma concentration time curve (AUC)
PK-Time to maximal plasma concentration (Tmax)
PK- terminal half-life; t1/2
PK-Apparent total body clearance (CL/F)
PK- Apparent Total Volume of Distribution (Vz/F)
Accumulation index of CC-90003
Response Rate based on RECIST 1.1
Duration of Response
Disease Control
Progression Free Survival
Overall Survival
Maximum Tolerated Dose
Solid Tumors
Locally Advanced Tumors
Metastatic Solid Tumors
Relapsed or refractory, BRAFV600 or RAS-mutated solid tumors
Melanoma
Colorectal Carcinomas Papillary
Thyroid carcinomas
Pancreatic ductal Adenocarcinomas
Non -small cell lung cancer [NSCLC]