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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

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma, Small Cell

Intervention: Pomalidomide (Drug); Cisplatin (Drug); Etoposide (Drug)

Phase: Phase 1/Phase 2

Status: Terminated

Sponsored by: Celgene Corporation

Official(s) and/or principal investigator(s):
Ulf Jungnelius, MD, Study Director, Affiliation: Celgene Corporation

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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum Tolerated Dose (MTD)

Secondary outcome:

Number of Participants With Dose Limiting Toxicities (DLTs) During the MTD Phase

Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)

Duration of Response

Overall Survival

Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the MTD (Combination Treatment) Phase

Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Recovery Period or Maintenance (Monotherapy) Phase

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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/┬ÁL

- 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

Locations and Contacts

Ireland Cancer Center, Case Western Reserve University, Division of Hematology/Oncology, Cleveland, Ohio 44106, United States

Juranvinski Cancer Center - Medical Oncology, Hamilton, Ontario L8V 5C2, Canada

Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada

Pennsylvania State University, Hershey, Pennsylvania 17033, United States

Mc Gill University - Department of Oncology - Clinical Research Program, Montreal, Quebec H2W 1S6, Canada

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States

Additional Information

Starting date: February 2008
Last updated: May 7, 2013

Page last updated: August 23, 2015

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