A Phase I/II Study to Determine the MTD and Safety of CC-4047 Administered in Conjunction With Cisplatin and Etoposide

This study is currently recruiting participants.

Verified by Celgene Corporation, August 2009

First Received: September 27, 2007 Last Updated: August 10, 2009 History of Changes

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00537511

Purpose

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

Condition	Intervention	Phase
Carcinoma, Small Cell	Drug: Pomalidomide	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Etoposide Etoposide phosphate

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Appearance of dose-limiting toxicities [ Time Frame: During Cycle 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety of CC-4047 in combination with cisplatin and etoposide [ Time Frame: Cycles 2-6 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	December 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single: Experimental CC-4047 + cisplatin + etoposide	Drug: Pomalidomide Dose finding arm: Pomalidomide - (0.5-5.0mg QD days 1-14 of each 21 day cycle) + cisplatin + etoposide

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

signature of informed consent
Age >= 18
histologically or cytologically confirmed SCLC
extensive stage SCLC
ECOG 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, lenalidomide or thalidomide
concurrent use or anticipated use of anti-cancer agents
ANC < 1500/mm^3
platelets < 100 x 10^3/uL
serum creatinine >2.5 mg/dL
serum SGOT or SGPT > 3.0 x ULN
serum total bilirubin > 1.8 mg/dL
uncontrolled hypercalcemia
creatinine clearance <50 mL/min
uncontrolled hypertension
neuropathy >= grade 2
BMI >= 40
any other active invasive malignancy requiring treatment
known chronic infection with HIV, HBV or HCV
inability or unwillingness to comply with birth control requirements

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537511

Contacts

Contact: Javier Ferrada, MS

908-673-9552

jferrada@celgene.com

Locations

United States, Ohio
	Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
	Not yet recruiting
Hershey, Pennsylvania, United States, 17033
United States, Texas
	Recruiting
Dallas, Texas, United States, 75390
Canada, Ontario
	Recruiting
Hamilton, Ontario, Canada, L8V 5C2
	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
	Not yet recruiting
Montreal, Quebec, Canada, H2W 1S6

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Mark Jones, MD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation ( Jarl Ulf Jungnelius )
Study ID Numbers:	CC-4047-SCLC-002
Study First Received:	September 27, 2007
Last Updated:	August 10, 2009
ClinicalTrials.gov Identifier:	NCT00537511 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Etoposide phosphate
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Radiation-Sensitizing Agents
Cisplatin

Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Lung Diseases
Neuroepithelioma
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Etoposide
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009