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TerminatedPhase 1 / Phase 2NCT00537511
Official study title

A Phase I/II Study to Determine the Maximum Tolerated Dose (MTD) and Safety of CC-4047 (Pomalidomide) Administered in Conjunction With Cisplatin and Etoposide

Study summary

The purpose of this study is to determine the maximum tolerated dose and safety of CC-4047 (pomalidomide) given in combination with cisplatin and etoposide in patients with extensive disease small cell lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedPomalidomide and Cisplatin

Plus 1 other study approaches.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 19, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?6 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 / Phase 2
Sponsor
Celgene
Interventions being studied
Drug: Pomalidomide; Drug: Cisplatin; Drug: Etoposide
02
Explore related studies

How this study is categorized

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

Cancer type
Small cell lung cancer (SCLC)→
Treatment approach
Chemotherapy→
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
  • signature of informed consent
  • Age \>= 18
  • histologically or cytologically confirmed small cell lung cancer (SCLC)
  • extensive stage SCLC
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
  • brain metastases that are asymptomatic and do not require steroid control
  • females of child bearing potential must use two forms of birth control
Reasons someone may not be able to joinExclusion criteria
  • pregnant or lactating females
  • prior use of cytotoxic chemotherapy
  • surgery within 14 days of study
  • radiation within 14 days of study
  • prior therapy with CC-4047 (pomalidomide), lenalidomide or thalidomide
  • concurrent use or anticipated use of anti-cancer agents
  • absolute neutrophil count (ANC) \< 1500/mm\^3
  • platelets \< 100 x 10\^3/µL
  • serum creatinine \>2.5 mg/dL
  • serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) \> 3.0 x upper limit of normal (ULN)
  • serum total bilirubin \> 1.8 mg/dL
  • uncontrolled hypercalcemia
  • creatinine clearance \<50 mL/min
  • uncontrolled hypertension
  • neuropathy \>= grade 2
  • body mass index (BMI) \>= 40
  • any other active invasive malignancy requiring treatment
  • known chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • inability or unwillingness to comply with birth control requirements

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

  • Ireland Cancer Center, Case Western Reserve University, Division of Hematology/OncologyCleveland, Ohio
  • Pennsylvania State UniversityHershey, Pennsylvania
  • University of Texas Southwestern Medical CenterDallas, Texas
  • Juranvinski Cancer Center - Medical OncologyHamilton, Ontario
  • Princess Margaret HospitalToronto, Ontario
  • Mc Gill University - Department of Oncology - Clinical Research ProgramMontreal, Quebec

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 19, 2019. Always confirm current availability with the study team.

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