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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02313012




Registration number
NCT02313012
Ethics application status
Date submitted
5/12/2014
Date registered
9/12/2014
Date last updated
18/11/2019

Titles & IDs
Public title
Safety and PK Study of CC-90003 in Relapsed/Refractory Solid Tumors
Scientific 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
Secondary ID [1] 0 0
CC-90003-ST-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasm Metastasis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CC-90003

Experimental: 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.


Treatment: Drugs: CC-90003
CC-90003 PO once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Summary of the adverse events (type, severity, and incidence) related to CC-
Timepoint [1] 0 0
Up to 36 months
Primary outcome [2] 0 0
Dose Limiting Toxicities of CC-90003
Timepoint [2] 0 0
Up to 18 months
Primary outcome [3] 0 0
Maximum Tolerated Dose (MTD) of CC-90003
Timepoint [3] 0 0
Up to 36 months
Primary outcome [4] 0 0
Pharmacokinetics (PK) observed maximum concentration (Cmax)
Timepoint [4] 0 0
Cycle 1, Day 1, 2, 3 (predose), 8, 11 (predose), 15, 16, , Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation
Primary outcome [5] 0 0
PK-Area under the plasma concentration time curve (AUC)
Timepoint [5] 0 0
Cycle 1, Day 1, 2, 3, (predose) 8, 11 (predose), 15, 16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation
Primary outcome [6] 0 0
PK-Time to maximal plasma concentration (Tmax)
Timepoint [6] 0 0
Cycle 1, Day 1, 2, 3 (predose) 8, 11 (predose), 15, 16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation
Primary outcome [7] 0 0
PK- terminal half-life; t1/2
Timepoint [7] 0 0
Cycle 1, Day 1, 2, 3 (predose) 8, 11 (predose), 15, 16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation
Primary outcome [8] 0 0
PK-Apparent total body clearance (CL/F)
Timepoint [8] 0 0
Cycle 1, Day 1, 2, 3 (predose) 8, 11 (predose) 15, 16, , Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation
Primary outcome [9] 0 0
PK- Apparent Total Volume of Distribution (Vz/F)
Timepoint [9] 0 0
Cycle 1, Day 1, 2, 3 (predose) 8, 11 (predose), 15,16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation
Primary outcome [10] 0 0
Accumulation index of CC-90003
Timepoint [10] 0 0
Cycle 1, Day 1, 2, 3 (predose) 8, 11 (predose), 15, 16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation
Secondary outcome [1] 0 0
Response Rate based on RECIST 1.1
Timepoint [1] 0 0
Up to 36 months
Secondary outcome [2] 0 0
Duration of Response
Timepoint [2] 0 0
Up to 36 months
Secondary outcome [3] 0 0
Disease Control
Timepoint [3] 0 0
Up to 36 Months
Secondary outcome [4] 0 0
Progression Free Survival
Timepoint [4] 0 0
Up to 36 months
Secondary outcome [5] 0 0
Overall Survival
Timepoint [5] 0 0
Up to 36 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/05/2016
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02313012
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gordon Bray, MD
Address 0 0
Celgene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02313012