TerminatedPhase 1

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

United States, Australia19 participantsStarted 2015-01-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Eligible study subjects in Part 1 and Part 2 must be 18 years or older
✓. 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
✓. Eligible study subjects must have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
✓. 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

✕. Subjects with symptomatic or unstable CNS metastases
✕. Subjects with a history of recent (within 28 days) systemic therapy for their underlying malignancy
✕. Subjects who have had surgery/radiotherapy within 2 weeks prior to start of study

What they're measuring

Summary of the adverse events (type, severity, and incidence) related to CC-

Timeframe: Up to 36 months

Dose Limiting Toxicities of CC-90003

Timeframe: Up to 18 months

Maximum Tolerated Dose (MTD) of CC-90003

Timeframe: Up to 36 months

Pharmacokinetics (PK) observed maximum concentration (Cmax)

Timeframe: Cycle 1, Day 1, 2, 3 (predose), 8, 11 (predose), 15, 16, , Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation

PK-Area under the plasma concentration time curve (AUC)

Timeframe: Cycle 1, Day 1, 2, 3, (predose) 8, 11 (predose), 15, 16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation

PK-Time to maximal plasma concentration (Tmax)

Timeframe: Cycle 1, Day 1, 2, 3 (predose) 8, 11 (predose), 15, 16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation

PK- terminal half-life; t1/2

Timeframe: Cycle 1, Day 1, 2, 3 (predose) 8, 11 (predose), 15, 16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation

Trial details

NCT IDNCT02313012

SponsorCelgene

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-05-03

View on ClinicalTrials.gov More Neoplasm Metastasis trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Eligible study subjects in Part 1 and Part 2 must be 18 years or older
✓. 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
✓. Eligible study subjects must have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
✓. 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

✕. Subjects with symptomatic or unstable CNS metastases
✕. Subjects with a history of recent (within 28 days) systemic therapy for their underlying malignancy
✕. Subjects who have had surgery/radiotherapy within 2 weeks prior to start of study

What they're measuring

Summary of the adverse events (type, severity, and incidence) related to CC-

Timeframe: Up to 36 months

Dose Limiting Toxicities of CC-90003

Timeframe: Up to 18 months

Maximum Tolerated Dose (MTD) of CC-90003

Timeframe: Up to 36 months

Pharmacokinetics (PK) observed maximum concentration (Cmax)

Timeframe: Cycle 1, Day 1, 2, 3 (predose), 8, 11 (predose), 15, 16, , Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation

PK-Area under the plasma concentration time curve (AUC)

Timeframe: Cycle 1, Day 1, 2, 3, (predose) 8, 11 (predose), 15, 16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation

PK-Time to maximal plasma concentration (Tmax)

Timeframe: Cycle 1, Day 1, 2, 3 (predose) 8, 11 (predose), 15, 16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation

PK- terminal half-life; t1/2

Timeframe: Cycle 1, Day 1, 2, 3 (predose) 8, 11 (predose), 15, 16, Cycle 2, Day 1, Cycle 3, Day 1 and at discontinuation