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Obatoclax Mesylate and Topotecan Hydrochloride in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer or Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00521144
First received: August 24, 2007
Last updated: July 21, 2014
Last verified: December 2013
Results First Received: October 11, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Small Cell Lung Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions: Drug: obatoclax mesylate
Drug: topotecan hydrochloride
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Protocol Open to Accrual 8/7/2007 Primary Completion Date 8/10/2010 Recruitment Location at medical clinic

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
Phase I; Level 1: Obatoclax Mesylate + Topetecan Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
Phase I; Level 2: Obatoclax Mesylate + Topetecan Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
Phase I; Level 3: Obatoclax Mesylate + Topetecan Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
Phase I; Level 4: Obatoclax Mesylate + Topotecan Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
Phase II Obatoclax Mesylate + Topotecan in SCLC Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2

Participant Flow:   Overall Study
    Phase I; Level 1: Obatoclax Mesylate + Topetecan     Phase I; Level 2: Obatoclax Mesylate + Topetecan     Phase I; Level 3: Obatoclax Mesylate + Topetecan     Phase I; Level 4: Obatoclax Mesylate + Topotecan     Phase II Obatoclax Mesylate + Topotecan in SCLC  
STARTED     6     5     3     1     7  
COMPLETED     2     2     1     0     0  
NOT COMPLETED     4     3     2     1     7  
Not Treated                 0                 0                 0                 1                 0  
Adverse Event                 0                 1                 0                 0                 1  
Progressive Disease                 4                 2                 2                 0                 6  



  Baseline Characteristics
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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
Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2 Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2 Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
Phase II Obatoclax Mesylate + Topotecan in SCLC Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
Total Total of all reporting groups

Baseline Measures
    Phase I Obatoclax Mesylate + Topotecan in Solid Tumors     Phase II Obatoclax Mesylate + Topotecan in SCLC     Total  
Number of Participants  
[units: participants]
  15     7     22  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     4     13  
>=65 years     6     3     9  
Age  
[units: years]
Mean ± Standard Deviation
  50  ± 33.9411255     64  ± 12.72792206     50  ± 6.363961031  
Gender  
[units: participants]
     
Female     8     6     14  
Male     7     1     8  
Region of Enrollment  
[units: participants]
     
United States     15     7     22  



  Outcome Measures

1.  Primary:   Overall Response Rate (Phase II)   [ Time Frame: Every 6 weeks, assessed up to 30 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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. Lee Krug
Organization: Memorial Sloan-Kettering Cancer Center
phone: 646 888 4201
e-mail: krugl@mskcc.org


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00521144     History of Changes
Obsolete Identifiers: NCT01645657
Other Study ID Numbers: NCI-2009-00252, 07-082, CDR0000561779
Study First Received: August 24, 2007
Results First Received: October 11, 2013
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration