ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Sunitinib In Young Patients With Advanced Gastrointestinal Stromal Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01396148
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Gastrointestinal Stromal Tumors
Interventions: Drug: sunitinib malate dose escalation
Drug: sunitinib malate

  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
Sunitinib Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.

Participant Flow:   Overall Study
    Sunitinib
STARTED   6 
COMPLETED   5 
NOT COMPLETED   1 
Patient Decision                1 



  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 full analysis set (FAS) included all enrolled participants regardless of what treatment, if any, was received.

Reporting Groups
  Description
Sunitinib Participants received Sunitinib capsules orally at a dose based on body surface area (BSA) (minimum dose of 15 milligram/ meter square [mg/m^2] up to a maximum dose of 30 mg/m^2) once daily, from Day 1 to 28 in each treatment cycle of 42 days (up to a maximum of 18 cycles) until completion of study treatment, disease progression, unacceptable toxicity, required a treatment rest (greater than [>4] weeks), withdrawal of participant consent, or if other withdrawal criteria were met.

Baseline Measures
   Sunitinib 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.3  (1.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  83.3% 
Male      1  16.7% 
Race/Ethnicity, Customized 
[Units: Participants]
 
White   5 
Asian   1 


  Outcome Measures

1.  Primary:   Maximum Observed Plasma Concentration (Cmax) of Sunitinib and Its Metabolite   [ Time Frame: Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose ]

2.  Primary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) for Sunitinib and Its Metabolite   [ Time Frame: Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose ]

3.  Primary:   Area Under the Plasma Concentration-Time Curve From Time Zero to 8 Hours Post Dose AUC(0-8) for Sunitinib and Its Metabolite   [ Time Frame: Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose ]

4.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to end of study (up to Cycle 18, each cycle was of 42 days) ]

5.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0   [ Time Frame: Baseline up to end of study (up to Cycle 18, each cycle was of 42 days) ]

6.  Secondary:   Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to end of study (up to Cycle 18, each cycle was of 42 days) ]

7.  Secondary:   Number of Participants With Clinically Significant Laboratory Abnormalities   [ Time Frame: Baseline up to end of study (up to Cycle 18, each cycle was of 42 days) ]

8.  Secondary:   Number of Participants With Objective Response   [ Time Frame: Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days) ]

9.  Secondary:   Duration of Response   [ Time Frame: Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days) ]

10.  Secondary:   Progression-Free Survival   [ Time Frame: Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days) ]

11.  Secondary:   Overall Survival   [ Time Frame: Baseline until death or discontinuation from the study whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days) ]

12.  Secondary:   Number of Participants With Adverse Events Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) for Pharmacokinetic (PK) Subgroups   [ Time Frame: Cycle 1 Day 28 up to Cycle 3 (each cycle 42 days) ]

13.  Secondary:   Pearson Correlation Coefficient Between Percent Change From Baseline in Laboratory Parameters With Total Drug (Sunitinib + SU012662) Concentration   [ Time Frame: Baseline, Day 28 of Cycle 1, Cycle 2 and Cycle 3 (each cycle was of 42 days) ]

14.  Secondary:   Pearson Correlation Coefficient Between Percent Change From Baseline in Vital Sign Results With Total Drug (Sunitinib + SU012662) Concentration   [ Time Frame: Baseline, Day 28 of Cycle 1, Cycle 2 and Cycle 3 (each cycle was of 42 days) ]

15.  Secondary:   Number of Participants With Stable Disease (SD), Partial Response (PR), Complete Response (CR) and Progressive Disease (PD) for PK Sub-groups   [ Time Frame: Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days) ]

16.  Secondary:   Progression Free Survival for PK Subgroups   [ Time Frame: Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days) ]

17.  Secondary:   Pearson Correlation Coefficient Between Progression Free Survival With Total Drug (Sunitinib + SU012662) Concentration   [ Time Frame: Baseline until disease progression or discontinuation from the study, or death, whichever occurred first (maximum duration: up to Cycle 18; each cycle was of 42 days ]

18.  Secondary:   Estimated Sunitinib Plasma Concentration at Which 50% of the Maximum Effect (EC50) for Each Selected Efficacy Parameter (e.g., Sum of Largest Diameters for Target Tumors) Was Observed   [ Time Frame: Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose ]

19.  Secondary:   Estimated Sunitinib Plasma Concentration at Which 50% of the Maximum Effect (EC50) for Each Selected Safety Endpoint (e.g., Absolute Neutrophil Count) Was Observed   [ Time Frame: Cycle 1 Day 1: pre-dose, 2, 4, 6, and 8 hours post-dose ]

20.  Primary:   Estimated Steady-state Maximum Plasma Concentration (Cmax) for Sunitinib and Its Active Metabolite SU012662   [ Time Frame: Weeks 1-18 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

21.  Primary:   Estimated Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours Post Dose (AUC24) for Sunitinib and Its Active Metabolite SU012662   [ Time Frame: Weeks 1-18 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

22.  Primary:   Estimated Oral Clearance (CL/F) for Sunitinib   [ Time Frame: Weeks 1-18 ]
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
Data for outcome measures 1, 2 and 3 will be estimated and reported separately as part of the Non-linear Mixed Effects Modeling analysis and will be provided once available.


  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 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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01396148     History of Changes
Other Study ID Numbers: A6181196
2011-002008-33 ( EudraCT Number )
First Submitted: July 13, 2011
First Posted: July 18, 2011
Results First Submitted: February 12, 2018
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018