This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Study of Hsp90 Inhibitor, STA-9090 for Relapsed or Refractory Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Synta Pharmaceuticals Corp.
Information provided by (Responsible Party):
David M. Jackman, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01173523
First received: July 29, 2010
Last updated: February 28, 2017
Last verified: February 2017
Results First Received: February 28, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Small Cell Lung Cancer
Intervention: Drug: STA-9090

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients enrolled from July 2010 through March 2013.

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
Cohort A: STA-9090 Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
Cohort B: STA-9090 Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.

Participant Flow:   Overall Study
    Cohort A: STA-9090   Cohort B: STA-9090
STARTED   13   12 
COMPLETED   0 [1]   0 [1] 
NOT COMPLETED   13   12 
Clinical Progression                1                1 
Progressive Disease                10                8 
Other                2                3 
[1] Since treatment was not of fixed duration, all participants were considered as 'Not Completed'.



  Baseline Characteristics
  Hide 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.
The analysis dataset is comprised of all treated patients.

Reporting Groups
  Description
Cohort A: STA-9090 Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
Cohort B: STA-9090 Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
Total Total of all reporting groups

Baseline Measures
   Cohort A: STA-9090   Cohort B: STA-9090   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   12   25 
Age 
[Units: Years]
Median (Full Range)
 62 
 (44 to 72) 
 59.5 
 (43 to 70) 
 61 
 (43 to 72) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  38.5%      4  33.3%      9  36.0% 
Male      8  61.5%      8  66.7%      16  64.0% 
Region of Enrollment 
[Units: Participants]
     
United States   13   12   25 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   8-Week Progression-Free Rate   [ Time Frame: Disease was evaluated radiographically at baseline and every 8 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was the first 8 week disease re-assessment. ]

2.  Secondary:   Overall Response Rate   [ Time Frame: Disease was evaluated radiographically at baseline and every 8 weeks on treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles in this study cohort. ]

3.  Secondary:   Progression-Free Survival   [ Time Frame: Disease was evaluated radiographically at baseline and every 8 weeks on treatment. Treatment duration was a median of 2 cycles (parallel to 2 months given the 4 week cycle length) and range of 1-2 cycles in this study cohort. ]

4.  Secondary:   Overall Survival   [ Time Frame: Long-term follow-up for survival occurred every 4 weeks. As of this analysis, follow-up among survivors was a median (range) of 11.5 months (0.9-47.9). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: David M. Jackman, MD
Organization: Dana-Farber Cancer Institute
phone: 617.632.3468



Responsible Party: David M. Jackman, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01173523     History of Changes
Other Study ID Numbers: 10-048
Study First Received: July 29, 2010
Results First Received: February 28, 2017
Last Updated: February 28, 2017