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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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CC-90003-ST-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasm Metastasis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Summary of the adverse events (type, severity, and incidence) related to CC-
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 36 months
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Primary outcome [2]
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Dose Limiting Toxicities of CC-90003
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Assessment method [2]
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Number of participants with dose limiting toxicities during the Dose Escalation Phase
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Timepoint [2]
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Up to 18 months
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Primary outcome [3]
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Maximum Tolerated Dose (MTD) of CC-90003
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Assessment method [3]
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The MTD is defined as the highest dose level at which no more than 1 in 6 participants experiences a dose- limiting toxicity (DLT) during the first 28 day cycle of treatment
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Timepoint [3]
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Up to 36 months
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Primary outcome [4]
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Pharmacokinetics (PK) observed maximum concentration (Cmax)
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Assessment method [4]
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The maximally observed plasma concentration of CC-90003 (Cmax)
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Timepoint [4]
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Cycle 1, Day 1, 2, 3 (predose), 8, 11 (predose), 15, 16, , Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation
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Primary outcome [5]
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PK-Area under the plasma concentration time curve (AUC)
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Assessment method [5]
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Area under the plasma concentration -time curve of CC-90003
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Timepoint [5]
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Cycle 1, Day 1, 2, 3, (predose) 8, 11 (predose), 15, 16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation
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Primary outcome [6]
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PK-Time to maximal plasma concentration (Tmax)
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Assessment method [6]
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The time to reach Cmax
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Timepoint [6]
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Cycle 1, Day 1, 2, 3 (predose) 8, 11 (predose), 15, 16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation
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Primary outcome [7]
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PK- terminal half-life; t1/2
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Assessment method [7]
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Terminal phase elimination half-life (t1/2) is calculated as follows: t1/2 =ln(2)/?z, where ?z is the first order rate constant associated with the terminal portion of the CC-90003 plasma concentration curve
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Timepoint [7]
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Cycle 1, Day 1, 2, 3 (predose) 8, 11 (predose), 15, 16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation
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Primary outcome [8]
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PK-Apparent total body clearance (CL/F)
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Assessment method [8]
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The apparent total body clearance of CC-90003 from plasma
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Timepoint [8]
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Cycle 1, Day 1, 2, 3 (predose) 8, 11 (predose) 15, 16, , Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation
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Primary outcome [9]
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PK- Apparent Total Volume of Distribution (Vz/F)
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Assessment method [9]
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PK- Apparent Total Volume of Distribution (Vz/F) During the terminal phase for CC- 90003
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Timepoint [9]
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Cycle 1, Day 1, 2, 3 (predose) 8, 11 (predose), 15,16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation
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Primary outcome [10]
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Accumulation index of CC-90003
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Assessment method [10]
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Accumulation represents the relationship between the dosing interval and the rate of elimination for the drug
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Timepoint [10]
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Cycle 1, Day 1, 2, 3 (predose) 8, 11 (predose), 15, 16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation
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Secondary outcome [1]
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Response Rate based on RECIST 1.1
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Assessment method [1]
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The proportion of subjects who achieve a best response of CR or PR.
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Timepoint [1]
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Up to 36 months
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Secondary outcome [2]
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Duration of Response
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Assessment method [2]
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Duration of response is the time from the start of study treatment until the first documentation of an objective response (either CR or PR).
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Timepoint [2]
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Up to 36 months
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Secondary outcome [3]
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Disease Control
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Assessment method [3]
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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
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Timepoint [3]
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Up to 36 Months
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Secondary outcome [4]
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Progression Free Survival
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Assessment method [4]
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PFS is defined as the time from the start of study treatment until progression (PD) or patient death (any cause), whichever occurs first
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Timepoint [4]
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Up to 36 months
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Secondary outcome [5]
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Overall Survival
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Assessment method [5]
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Overall survival is defined as the time from start of study treatment until the date of death from any cause.
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Timepoint [5]
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Up to 36 months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/01/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
3/05/2016
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Sample size
Target
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Accrual to date
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Final
19
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Connecticut
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Country [3]
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United States of America
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State/province [3]
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North Carolina
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Country [4]
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United States of America
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State/province [4]
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Tennessee
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Celgene
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02313012
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gordon Bray, MD
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Address
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Celgene
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02313012
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