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TerminatedPhase 1NCT02313012
Official study title

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

Study 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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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCC-90003

The study team can explain what participation involves.

Who it may be forRecurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 18, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?Celgene

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Celgene
Interventions being studied
Drug: CC-90003
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting
Recurrent or relapsed→Resistant or refractory→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Cedars Sinai Medical Center, Inflammatory Bowel Disease CenterLos Angeles, California
  • Smilow Cancer CenterNew Haven, Connecticut
  • Levine Cancer InstituteCharlotte, North Carolina
  • Sarah Cannon Cancer CenterNashville, Tennessee
  • Peter MacCallum Cancer CentreMelbourne

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 18, 2019. Always confirm current availability with the study team.

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