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
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.
Checked against the public recordLast updated Nov 19, 2019 · Source: ClinicalTrials.gov
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
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion 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 Exclusion 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.
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.