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Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01638546
Recruitment Status : Completed
First Posted : July 11, 2012
Results First Posted : March 27, 2018
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Recurrent Small Cell Lung Carcinoma
Interventions: Other: Laboratory Biomarker Analysis
Other: Placebo
Drug: Temozolomide
Drug: Veliparib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Veliparib and Temozolomide)

Patients receive veliparib PO BID on days 1-7 and temozolomide PO on days 1-5.

Laboratory Biomarker Analysis: Correlative studies

Temozolomide: Given PO

Veliparib: Given PO

Arm II (Placebo and Temozolomide)

Patients receive placebo PO BID on days 1-7 and temozolomide as in Arm I.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given PO

Temozolomide: Given PO


Participant Flow:   Overall Study
    Arm I (Veliparib and Temozolomide)   Arm II (Placebo and Temozolomide)
STARTED   52   45 
COMPLETED   51   42 
NOT COMPLETED   1   3 
Adverse Event                1                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I (Veliparib and Temozolomide)

Patients receive veliparib PO BID on days 1-7 and temozolomide PO on days 1-5.

Laboratory Biomarker Analysis: Correlative studies

Temozolomide: Given PO

Veliparib: Given PO

Arm II (Placebo and Temozolomide)

Patients receive placebo PO BID on days 1-7 and temozolomide as in Arm I.

Laboratory Biomarker Analysis: Correlative studies

Placebo: Given PO

Temozolomide: Given PO

Total Total of all reporting groups

Baseline Measures
   Arm I (Veliparib and Temozolomide)   Arm II (Placebo and Temozolomide)   Total 
Overall Participants Analyzed 
[Units: Participants]
 52   45   97 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      31  59.6%      31  68.9%      62  63.9% 
>=65 years      21  40.4%      14  31.1%      35  36.1% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      29  55.8%      23  51.1%      52  53.6% 
Male      23  44.2%      22  48.9%      45  46.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4   7.7%      1   2.2%      5   5.2% 
White      47  90.4%      43  95.6%      90  92.8% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   1.9%      1   2.2%      2   2.1% 


  Outcome Measures

1.  Primary:   Progression-free Survival, Calculated as the Proportion of Patients Alive and Without Evidence of Disease   [ Time Frame: From randomization to time of progression or death, whichever occurs first, assessed at 4 months ]

2.  Secondary:   Overall Survival   [ Time Frame: From randomization to time of death, assessed up to 5 years ]

3.  Secondary:   ORR by RECIST 1.1 Criteria   [ Time Frame: Assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Other Pre-specified:   BRCA1 Expression, Assessed by Immunohistochemistry   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Other Pre-specified:   Changes in Plasma Markers   [ Time Frame: Baseline to up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Other Pre-specified:   GammaH2AX Levels   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   MGMT Expression, Assessed by Immunohistochemistry   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Number of Circulating Tumor Cells   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   PARP-1 Expression   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Other Pre-specified:   Presence of MGMT Promoter Methylation, Assessed by the EpiTyper Assay   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

11.  Other Pre-specified:   PTEN Expression, Assessed by Immunohistochemistry   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

12.  Other Pre-specified:   RAD51 Expression, Assessed by Immunohistochemistry   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Charles Rudin
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4527
e-mail: rudinc@mskcc.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01638546     History of Changes
Other Study ID Numbers: NCI-2012-01130
NCI-2012-01130 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB #12-021
12-021
CDR0000737062
9026 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
9026 ( Other Identifier: CTEP )
N01CM00039 ( U.S. NIH Grant/Contract )
P30CA008748 ( U.S. NIH Grant/Contract )
U01CA070095 ( U.S. NIH Grant/Contract )
UM1CA186691 ( U.S. NIH Grant/Contract )
First Submitted: July 9, 2012
First Posted: July 11, 2012
Results First Submitted: February 27, 2018
Results First Posted: March 27, 2018
Last Update Posted: June 7, 2018