Clinical Trials /

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

NCT02313012

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Terminated

Phase:

Phase 1

Trial Eligibility

Document

Safety and PK Study of <span class="go-doc-concept go-doc-intervention">CC-90003</span> in Relapsed/Refractory Solid Tumors

Title

  • Brief Title: Safety and PK Study of CC-90003 in Relapsed/Refractory Solid Tumors
  • Official Title: A Phase 1a Multicenter, Open-label, Safety, Tolerability and Pharmacokinetic Study of CC-90003, a Selective Extracellular Signal-Regulated Kinase (ERK) Inhibitor in Subjects With Locally-Advanced or Metastatic, Relapsed, or Refractory BRAF or RAS-mutated Malignancies
  • Clinical Trial IDs

    NCT ID: NCT02313012

    ORG ID: CC-90003-ST-001

    Trial Conditions

    Neoplasm Metastasis

    Trial Interventions

    Drug Synonyms Arms
    CC-90003 Dose Level 1 CC-90003

    Trial Purpose

    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.

    Trial Arms

    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

    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

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Response Rate based on RECIST 1.1

    Duration of Response

    Disease Control

    Progression Free Survival

    Overall Survival

    Trial Keywords

    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]