Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase II Trial of OSI-906 and Sorafenib in Advanced Hepatocellular Cancer

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: NCT01334710
Recruitment Status : Terminated (safety issue observed on another hepatocellular study using OSI906)
First Posted : April 13, 2011
Results First Posted : October 12, 2012
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
OSI Pharmaceuticals
Information provided by (Responsible Party):
Bassel El-Rayes, Emory University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Liver Cancer
Intervention Drug: Sorafenib and OSI-906
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sorafenib and OSI-906
Hide Arm/Group Description

This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.

Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily

Period Title: Overall Study
Started 3
Completed 0 [1]
Not Completed 3
Reason Not Completed
Trial was terminated             3
[1]
Due to safety signals in a parallel trial ON OSI906 in hepatocellular cancer the trial was stopped.
Arm/Group Title Sorafenib and OSI-906
Hide Arm/Group Description

This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.

Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
1
  33.3%
Male
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Comparison of MRI/CT Scans to Pre-treatment Scan
Hide Description Efficacy will be measured by evaluating the number of patients who do not have disease progression (measured by CT or MRI scan) 5 months after starting treatment. Assessment of the endpoint of disease progression will be performed every 2 months using either CT or MRI scan. Participants will remain on the study until either evidence of disease progression or unacceptable side effects develop. This period is expected to be on the average 6 months long.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Trial was terminated early.
Arm/Group Title Sorafenib and OSI-906
Hide Arm/Group Description:

This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.

Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Toxicity Assessment
Hide Description Evaluate the proportion of participants treated with OSI-906 and sorafenib who develop serious adverse events.
Time Frame 28 days from study entry
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sorafenib and OSI-906
Hide Arm/Group Description:

This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.

Sorafenib and OSI-906: Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily

Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sorafenib and OSI-906
Hide Arm/Group Description

This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.

Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily

All-Cause Mortality
Sorafenib and OSI-906
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sorafenib and OSI-906
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Sorafenib and OSI-906
Affected / at Risk (%)
Total   0/3 (0.00%) 
A second trial evaluating OSI906 in hepatocellular cancer was being run in parallel to this trial. There were safety signals in the second trial which led to stopping this trial.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Bassel El-Rayes
Organization: Emory University
Phone: 404-778-1900
Responsible Party: Bassel El-Rayes, Emory University
ClinicalTrials.gov Identifier: NCT01334710     History of Changes
Other Study ID Numbers: IRB00047003
WCI1887-10 ( Other Identifier: Other )
First Submitted: April 6, 2011
First Posted: April 13, 2011
Results First Submitted: September 12, 2012
Results First Posted: October 12, 2012
Last Update Posted: November 21, 2017