Dose Escalating Study of the Safety and Efficacy of Patupilone, q3w, in Patients With Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171834
First received: September 13, 2005
Last updated: January 6, 2014
Last verified: January 2014
Results First Received: January 11, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Non-Small-Cell Lung
Intervention: Drug: Patupilone

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Patupilone ≤7.0 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
Patupilone 7.5-8.0 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
Patupilone 8.5-9.5 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
Patupilone 10.0-11.5 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
Patupilone 12.0-13.0 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.

Participant Flow:   Overall Study
    Patupilone ≤7.0 mg/m^2 (Phase I)     Patupilone 7.5-8.0 mg/m^2 (Phase I)     Patupilone 8.5-9.5 mg/m^2 (Phase I)     Patupilone 10.0-11.5 mg/m^2 (Phase I)     Patupilone 12.0-13.0 mg/m^2 (Phase I)     Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort     Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort  
STARTED     6     12     12     12     8     35     4  
Completed 6 Cycles of Treatment     0     0     1     0     2     1     0  
COMPLETED     0     0     0     0     0     0     0  
NOT COMPLETED     6     12     12     12     8     35     4  
Adverse Event                 2                 1                 3                 2                 2                 15                 1  
Withdrawal by Subject                 0                 2                 0                 1                 1                 1                 0  
Death from study indication                 0                 1                 0                 0                 1                 0                 0  
Disease Progression                 4                 8                 8                 9                 2                 18                 3  
Treatment Duration Completed                 0                 0                 1                 0                 2                 1                 0  



  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.
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Reporting Groups
  Description
Patupilone ≤7.0 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
Patupilone 7.5-8.0 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
Patupilone 8.5-9.5 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
Patupilone 10.0-11.5 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
Patupilone 12.0-13.0 mg/m^2 (Phase I) Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
Total Total of all reporting groups

Baseline Measures
    Patupilone ≤7.0 mg/m^2 (Phase I)     Patupilone 7.5-8.0 mg/m^2 (Phase I)     Patupilone 8.5-9.5 mg/m^2 (Phase I)     Patupilone 10.0-11.5 mg/m^2 (Phase I)     Patupilone 12.0-13.0 mg/m^2 (Phase I)     Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort     Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort     Total  
Number of Participants  
[units: participants]
  6     12     12     12     8     35     4     89  
Age  
[units: years]
Mean ± Standard Deviation
  58.3  ± 12.01     59.4  ± 8.98     57.8  ± 9.31     57.6  ± 9.07     56.3  ± 13.31     63.3  ± 8.04     60.5  ± 9.71     57.9  ± 9.85  
Gender  
[units: participants]
               
Female     3     5     4     4     2     10     2     30  
Male     3     7     8     8     6     25     2     59  
Race/Ethnicity, Customized  
[units: participants]
               
Caucasian     6     12     11     12     8     35     4     88  
Black or African American     0     0     1     0     0     0     0     1  



  Outcome Measures
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1.  Primary:   Phase I: Number of Total Dose-limiting Toxicity (DLT) During Dose Escalation to Determine Maximum Tolerated Dose (MTD)   [ Time Frame: Cycle 1 (21 days) ]

2.  Primary:   Phase II: Number of Participants With Best Overall Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: At baseline, then every second cycle (approximately every 6 weeks), until disease progression or discontinuation. Average 18 weeks. ]

3.  Secondary:   Number of Participants With Best Overall Response-Phase I   [ Time Frame: Best achieved overall response according to RECIST from start of study until study discontinuation. Imaging was assessed every second cycle (ie. approximately every 6 weeks) until disease progression or discontinuation. Average 18 weeks ]

4.  Secondary:   Overall Survival Time-Phase I and Phase II   [ Time Frame: From start of study drug to date of death due to any cause. Follow-up after treatment discontinuation approximately every 3 months until approximately 70% of participants have reached the survival endpoint. Average 9.75 months ]

5.  Secondary:   Time to Progression (TTP)-Phase I and Phase II   [ Time Frame: From baseline, then every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from study. Average 18 weeks ]

6.  Secondary:   Duration of Stable Disease-Phase I and Phase II   [ Time Frame: Imaging was assessed every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from treatment . Average 18 weeks ]

7.  Secondary:   Time to Overall Response -Phase I and Phase II   [ Time Frame: From baseline, then every second cycle (i.e. approximately every 6 weeks), until disease progression or discontinuation from study. Average 18 weeks ]

8.  Secondary:   Duration of Overall Response -Phase I and Phase II   [ Time Frame: Duration of response according to RECIST from start of study until study discontinuation. Duration of response was assessed every second cycle ( i.e. approximately every 6 weeks) until disease progression or discontinuation from study. Average 18 weeks ]


  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
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  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00171834     History of Changes
Obsolete Identifiers: NCT00088127
Other Study ID Numbers: CEPO906A2209
Study First Received: September 13, 2005
Results First Received: January 11, 2011
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration