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A Phase I/II, Multi-Center, Open-Label, Dose-Escalation, Safety and Efficacy Study of PHY906 Plus Capecitabine in Patients With Advanced Pancreatic Carcinoma

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ClinicalTrials.gov Identifier: NCT00411762
Recruitment Status : Completed
First Posted : December 15, 2006
Results First Posted : March 27, 2015
Last Update Posted : March 27, 2015
Sponsor:
Collaborators:
PhytoCeutica
National Comprehensive Cancer Network
Roche Pharma AG
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Capecitabine
Drug: PHY906
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PHY906 Administration
Hide Arm/Group Description

PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle

Capecitabine

PHY906

Period Title: Overall Study
Started 25
Completed 20
Not Completed 5
Reason Not Completed
Withdrawal by Subject             5
Arm/Group Title PHY906 Administration
Hide Arm/Group Description PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 25 participants
64
(45 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
10
  40.0%
Male
15
  60.0%
1.Primary Outcome
Title Median Progression Free Survival
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame Up to 100 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
20 subjects received 2 cycles or more and were evaluated for response
Arm/Group Title PHY906 Administration
Hide Arm/Group Description:
PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: weeks
10.1
(0.4 to 54.1)
2.Secondary Outcome
Title Median Overall Survival
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame Up to 100 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
20 subjects received 2 cycles or more and were evaluated for response
Arm/Group Title PHY906 Administration
Hide Arm/Group Description:
PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: weeks
21.6
(0.4 to 84.1)
Time Frame Adverse events were collected through the duration of the study (approximately 4 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PHY906 Administration
Hide Arm/Group Description PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
All-Cause Mortality
PHY906 Administration
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PHY906 Administration
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PHY906 Administration
Affected / at Risk (%)
Total   10/25 (40.00%) 
Blood and lymphatic system disorders   
Anemia * 1  3/25 (12.00%) 
Neutropenia * 1  3/25 (12.00%) 
Thrombocytopenia * 1  3/25 (12.00%) 
Gastrointestinal disorders   
Anorexia * 1  8/25 (32.00%) 
Nausea/vomiting * 1  3/25 (12.00%) 
Diarrhea * 1  4/25 (16.00%) 
Constipation * 1  3/25 (12.00%) 
General disorders   
Dry mouth/taste alternation * 1  2/25 (8.00%) 
Fatigue * 1  7/25 (28.00%) 
Hand-Foot Syndrome * 1  5/25 (20.00%) 
Electrolytes Imblances * 1  2/25 (8.00%) 
Hepatobiliary disorders   
Elevated Liver Function Tests * 1  2/25 (8.00%) 
Skin and subcutaneous tissue disorders   
Mucositis * 1  4/25 (16.00%) 
Hyperpigmentation * 1  3/25 (12.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Howard Hochster
Organization: Yale University
EMail: Howard.Hochster@yale.edu
Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00411762     History of Changes
Other Study ID Numbers: 0512000905
First Submitted: December 13, 2006
First Posted: December 15, 2006
Results First Submitted: March 10, 2015
Results First Posted: March 27, 2015
Last Update Posted: March 27, 2015