NCT00537511

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2008

Typical duration for phase_1

Geographic Reach
2 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

April 17, 2013

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

2.8 years

First QC Date

September 27, 2007

Results QC Date

March 6, 2013

Last Update Submit

November 6, 2019

Conditions

Carcinoma, Small Cell

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD)

    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.)

    Cycle 1 (21 days)

Secondary Outcomes (6)

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

    Cycles 1 - 6 (21-day cycles)

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

    Cycles 1 -6 (21-day cycles)

  • Duration of Response

    From first Partial Response (PR) or Complete Response (CR) to disease progression (maximum of 19.4 weeks)

  • Overall Survival

    From enrollment through study termination (approximately 35 months)

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

    Cycles 1-6 (21-day cycles). Median (full range) duration of exposure (in weeks) to pomalidomide (MTD Phase): 1 mg, 17.9 (1.0, 20.3); 3 mg, 17.0 (16.9, 22.0); 4 mg, 14.0 (0.7, 22.0); 5 mg, 13.0 (2.0, 22.1). Cisplatin and etoposide: 15.3 (0.4, 20.6).

  • +1 more secondary outcomes

Study Arms (1)

Dose-finding arm: Pomalidomide + Cisplatin + Etoposide

EXPERIMENTAL

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.

Drug: PomalidomideDrug: CisplatinDrug: Etoposide

Interventions

PomalidomideDRUG
Also known as: CC-4047, Pomalyst
Dose-finding arm: Pomalidomide + Cisplatin + Etoposide
CisplatinDRUG
Also known as: Cisplatinum, CDDP, Platin
Dose-finding arm: Pomalidomide + Cisplatin + Etoposide
EtoposideDRUG
Also known as: Etoposide phosphate, VP-16, Etopophos
Dose-finding arm: Pomalidomide + Cisplatin + Etoposide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Ireland Cancer Center, Case Western Reserve University, Division of Hematology/Oncology

Cleveland, Ohio, 44106, United States

Location

Pennsylvania State University

Hershey, Pennsylvania, 17033, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Juranvinski Cancer Center - Medical Oncology

Hamilton, Ontario, L8V 5C2, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Mc Gill University - Department of Oncology - Clinical Research Program

Montreal, Quebec, H2W 1S6, Canada

Location

Related Publications (1)

  • Ellis 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: 23370364RESULT

MeSH Terms

Conditions

Carcinoma, Small Cell

Interventions

pomalidomideCisplatinEtoposideetoposide phosphate

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydrates

Results Point of Contact

Title
Associate Director, Clinical Trial Disclosure
Organization
Celgene
clinicaltrialdisclosure@celgene.com
1-888-260-1599

Study Officials

  • Ulf Jungnelius, MD

    Celgene Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2007

First Posted

October 1, 2007

Study Start

February 1, 2008

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

November 19, 2019

Results First Posted

April 17, 2013

Record last verified: 2019-11

Locations

US(3)CA(3)