Clinical trial · Interventional
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
A Multicenter, Phase I/IIA, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose and To Evaluate the Safety Profile of CC-4047 Administered in Combination With Cisplatin and Etoposide in Patients With Extensive Disease Small Cell Lung Cancer
NCT00537511CI-TRIAL-00041771terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was terminated for administrative reasons.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Small Cell | Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Pomalidomide | Drug | Pomalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose-finding arm: Pomalidomide + Cisplatin + Etoposide
- description
- Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m\^2 and IV etoposide 100 mg/m\^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
- interventionNames
- Drug: Pomalidomide
- Drug: Cisplatin
- Drug: Etoposide
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- Cycle 1 (21 days)
- description
- The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 21-day cycle of treatment. The MTD Phase included the Treatment period (Cycle 1: Identification of the MTD) and the Extension period (Cycles 2 to 6: Confirmation of Safety of the MTD). (See Secondary Outcome Measure 2 for data on DLTs.)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTEllis PM, Jungnelius U, Zhang J, Fandi A, Beck R, Shepherd FA. A phase I study of pomalidomide (CC-4047) in combination with cisplatin and etoposide in patients with extensive-stage small-cell lung cancer. J Thorac Oncol. 2013 Apr;8(4):423-8. doi: 10.1097/JTO.0b013e318282707b. PMID 23370364