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Phase 1-2 Vatalanib and Gemcitabine in Advanced Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00185588
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
George Albert Fisher, Stanford University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Drug: Vatalanib
Drug: Gemcitabine

  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
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250

Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily

Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12

Gemcitabine: 850 mg/m2

Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250

Gemcitabine 850 mg/m2 + vatalanib 1250 mg

Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12

Gemcitabine: 850 mg/m2

Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500

Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter

Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12

Gemcitabine: 850 mg/m2

Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500

Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily

Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12

Gemcitabine: 850 mg/m2


Participant Flow:   Overall Study
    Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250   Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250   Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500   Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500
STARTED   6   4   6   17 
COMPLETED   3   2   0   13 
NOT COMPLETED   3   2   6   4 
Adverse Event                3                1                4                2 
Lost to Follow-up                0                0                1                2 
Withdrawal by Subject                0                1                0                0 
Physician Decision                0                0                1                0 



  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.
33 adult patients with advanced pancreatic cancer

Reporting Groups
  Description
Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250

Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily

Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12

Gemcitabine: 850 mg/m2

Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250

Gemcitabine 850 mg/m2 + vatalanib 1250 mg

Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12

Gemcitabine: 850 mg/m2

Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500

Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter

Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12

Gemcitabine: 850 mg/m2

Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500

Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily

Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12

Gemcitabine: 850 mg/m2

Total Total of all reporting groups

Baseline Measures
   Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250   Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250   Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500   Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   4   6   17   33 
Age 
[Units: Years]
Median (Full Range)
 55 
 (40 to 76) 
 69 
 (53 to 82) 
 70 
 (53 to 75) 
 55 
 (40 to 79) 
 58 
 (40 to 82) 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   5   2   2   13   22 
>=65 years   1   2   4   4   11 
Gender 
[Units: Participants]
         
Female   4   2   2   7   15 
Male   2   2   4   10   18 
Region of Enrollment 
[Units: Participants]
         
United States   6   4   6   17   33 


  Outcome Measures

1.  Primary:   Time-to-Treatment Failure (Intent-To-Treat Analysis)   [ Time Frame: 12 months ]

2.  Secondary:   Time-to-Progression, Evaluable Patients   [ Time Frame: 12 months ]


  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
No text entered.


  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: George Albert Fisher, Associate Professor of Medicine, Stanford University
Organization: Stanford University
phone: 650-725-9057
e-mail: georgeaf@stanford.edu



Responsible Party: George Albert Fisher, Stanford University
ClinicalTrials.gov Identifier: NCT00185588     History of Changes
Other Study ID Numbers: IRB-06999
95533 ( Other Identifier: Stanford University Alternate IRB Number )
CPTK787AUS08 ( Other Identifier: Novartis )
PANC0002 ( Other Identifier: OnCore )
First Submitted: September 12, 2005
First Posted: September 16, 2005
Results First Submitted: July 30, 2014
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014