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

URL:

https://clinicaltrials.gov/show/NCT02313012

Trial Eligibility

Document

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

  • ORG STUDY ID: CC-90003-ST-001
  • NCT ID: NCT02313012

Conditions

  • Neoplasm Metastasis

Interventions

DrugSynonymsArms
CC-90003Dose Level 1 CC-90003

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

NameTypeDescriptionInterventions
Dose Level 1 CC-90003ExperimentalCC-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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Summary of the adverse events (type, severity, and incidence) related to CC-
Time Frame:Up to 36 months
Safety Issue:
Description:An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values regardless of etiology.

Secondary Outcome Measures

Measure:Response Rate based on RECIST 1.1
Time Frame:Up to 36 months
Safety Issue:
Description:The proportion of subjects who achieve a best response of CR or PR.
Measure:Duration of Response
Time Frame:Up to 36 months
Safety Issue:
Description:Duration of response is the time from the start of study treatment until the first documentation of an objective response (either CR or PR).
Measure:Disease Control
Time Frame:Up to 36 Months
Safety Issue:
Description:The proportion of subjects who achieve a best response of SD (documented at least 56 days after the start of study treatment) PR, or CR
Measure:Progression Free Survival
Time Frame:Up to 36 months
Safety Issue:
Description:PFS is defined as the time from the start of study treatment until progression (PD) or patient death (any cause), whichever occurs first
Measure:Overall Survival
Time Frame:Up to 36 months
Safety Issue:
Description:Overall survival is defined as the time from start of study treatment until the date of death from any cause.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Celgene

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]

Last Updated

November 18, 2019