We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tandutinib in Treating Patients With Recurrent or Progressive Glioblastoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00379080
First Posted: September 21, 2006
Last Update Posted: April 7, 2017
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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: July 15, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Brain Tumor
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Interventions: Procedure: conventional surgery
Drug: tandutinib
Other: pharmacological study
Other: Tissue samples

  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 4/2007 through 6/2010. Patients accrued in the outpatient clinical setting. The first part of study was for patients who required surgery. Hence these patients were treated in-patient.

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 1- Phase 0

Patients receive oral tandutinib twice daily for 7 days. Patients then undergo biopsy or surgery to remove the tumor. Within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

conventional surgery

oral tandutinib

Pharmacological study

Tissue samples

Arm 2 - Phase 1

Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

tandutinib: Given orally

pharmacological study: Correlative studies

Arm 3 - Phase 2

Patients receive tandutinib as in phase I at the MTD determined in phase I.

600mg was the determined MTD in Dose Escalation

oral tandutinib

Pharmacological study

Tissue samples

tandutinib: Given orally

pharmacological study: Correlative studies

Tissue samples: Correlative studies


Participant Flow:   Overall Study
    Arm 1- Phase 0   Arm 2 - Phase 1   Arm 3 - Phase 2
STARTED   6   19   31 
COMPLETED   6   15   31 
NOT COMPLETED   0   4   0 
Withdrawal by Subject                0                4                0 



  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.
all pts had to have confirmed histological GBM, prior treatment wih RT and a MMSE of greater or equal to 15.

Reporting Groups
  Description
Arm 1 - Phase 0

Patients receive oral tandutinib twice daily for 7 days. Patients then undergo biopsy or surgery to remove the tumor. Within 2 weeks after biopsy or surgery, patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

conventional surgery

oral tandutinib

Pharmacological study

Tissue samples

Arm 2 - Phase 1

Phase I: Patients receive oral tandutinib twice daily* on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

tandutinib: Given orally

pharmacological study: Correlative studies

Arm 3 - Phase 2

Patients receive tandutinib as in phase I at the MTD determined in phase I.

600mg was the determined MTD in Dose Escalation

oral tandutinib

Pharmacological study

Tissue samples

tandutinib: Given orally

pharmacological study: Correlative studies

Tissue samples: Correlative studies

Total Total of all reporting groups

Baseline Measures
   Arm 1 - Phase 0   Arm 2 - Phase 1   Arm 3 - Phase 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   19   31   56 
Age 
[Units: Years]
Median (Full Range)
 61 
 (48 to 72) 
 56 
 (42 to 77) 
 54 
 (24 to 69) 
 56 
 (24 to 77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      2  33.3%      4  21.1%      7  22.6%      13  23.2% 
Male      4  66.7%      15  78.9%      24  77.4%      43  76.8% 
Karnofsky Performance Status [1] 
[Units: Percentage]
Median (Full Range)
 80 
 (60 to 100) 
 90 
 (60 to 100) 
 90 
 (60 to 100) 
 90 
 (60 to 100) 
[1] Higher score better 100 normal no complaints/disease 90 capable normal activity few symptoms/disease 80 normal activity, some difficulty some symptoms/signs 70 caring for self not capable normal activity/work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care/help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures/treatment 10 moribund rapidly progressive fatal disease processes 0 death
Mini Mental Score [1] 
[Units: Units on a scale]
Median (Full Range)
 29 
 (20 to 30) 
 30 
 (22 to 30) 
 29 
 (15 to 30) 
 29 
 (15 to 30) 
[1] The mini–mental state examination (MMSE) is a 30-point questionnaire test used to screen for cognitive impairment. Commonly used to screen for dementia. It is also used to estimate the severity of cognitive impairment and to follow the course of cognitive changes in an individual over time. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating lists of words, arithmetic such as the serial sevens, language use and comprehension, and basic motor skills. The Higher your score, the higher your function. Scale Ranges from 1-30
Steroids 
[Units: Participants]
       
Yes   5   10   8   23 
No   1   9   23   33 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose of Tandutinib Defined by Dose Limiting Toxicities (Phase 1)   [ Time Frame: cycle 1 - 28 days ]

2.  Primary:   To Determine the Tumor/Plasma Ratio of in Subjects With Recurrent GBM Undergoing Resections (Phase 0)   [ Time Frame: 7 days prior to surgery including surgery ]

3.  Primary:   Number of Dose Limiting Toxicities Per Dose Level   [ Time Frame: 28 days ]

4.  Primary:   Tumor Response (Complete Response and Partial Response) Rate (Phase II)   [ Time Frame: Up to 4 years ]

5.  Primary:   Pharmacokinetics (Max Concentration of Plasma) for Tandutinib in Phase 1 and Phase 2   [ Time Frame: 28 days ]

6.  Primary:   Pharmacokinetics (Apparent Terminal Phase Half-life) for Tandutinib in Phase 1 and Phase 2   [ Time Frame: 28 days ]

7.  Primary:   Pharmacokinetics (Area Under the Plasma Concentration Time Profile From Zero to Infinity (AUC)) for Tandutinib in Phase 1 and Phase 2   [ Time Frame: 28 days ]

8.  Primary:   Pharmacokinetics; Apparent Oral Clearance for Tandutinib in Phase 1 and Phase 2   [ Time Frame: 28 days ]

9.  Primary:   Pharmacokinetics; Apparent Oral Total Body Volume of Distribution for Tandutinib in Phase 1 and Phase 2   [ Time Frame: 28 days ]

10.  Primary:   Pharmacokinetics; Steady-state Trough Concentration for Tandutinib in Phase 1 and Phase 2   [ Time Frame: 28 days ]

11.  Secondary:   Overall Survival (Phase II)   [ Time Frame: Up to 4 years ]

12.  Secondary:   Six-month Progression-free Survival Rate (Phase II)   [ Time Frame: At 6 months ]

13.  Secondary:   Overall Failure Rate (Phase II)   [ Time Frame: up to 4 years ]

14.  Secondary:   Proportion of Patients With Serious or Life Threatening Toxicities   [ Time Frame: 2 year period ]

15.  Secondary:   Protein Expression Patterns Post Treatment - Loss or Gain   [ Time Frame: baseline - cycle 2 (28 days) ]


  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
Simon's two-stage design Phase 2, prespecified goal patients alive & progression-free survival 6-months not achieved first stage, 2nd stage not done & trial closed/stopped.


  More Information
  Hide 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: Stuart A Grossman, MD Director of ABTC
Organization: Adult Brain Tumor Consortium
phone: 410-955-8837
e-mail: grossman@jhmi.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00379080     History of Changes
Other Study ID Numbers: NCI-2009-00681
NCI-2009-00681 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000495253
NABTT 0504 ( Other Identifier: Adult Brain Tumor Consortium )
NABTT-0504 ( Other Identifier: CTEP )
U01CA137443 ( U.S. NIH Grant/Contract )
First Submitted: September 19, 2006
First Posted: September 21, 2006
Results First Submitted: July 15, 2016
Results First Posted: April 7, 2017
Last Update Posted: April 7, 2017