Randomized Phase 1/2 Open-Label Trial of PR104 and Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)

This study has been terminated.
(PR104 plus sorafenib was poorly tolerated in patients with advanced HCC)
Sponsor:
Information provided by (Responsible Party):
Proacta, Incorporated
ClinicalTrials.gov Identifier:
NCT00862082
First received: March 12, 2009
Last updated: July 19, 2013
Last verified: July 2013
Results First Received: May 31, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatocellular Carcinoma
Interventions: Drug: PR104 550 mg/m^2 + sorafenib
Drug: PR104 770 mg/m^2 + sorafenib

  Participant Flow
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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
PR104 550 mg/m^2 + Sorafenib 550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
PR104 770 mg/m^2 + Sorafenib 770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)

Participant Flow:   Overall Study
    PR104 550 mg/m^2 + Sorafenib     PR104 770 mg/m^2 + Sorafenib  
STARTED     8     6  
COMPLETED     3     5  
NOT COMPLETED     5     1  
Sponsor decision to terminate the study                 5                 0  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
PR104 550 mg/m^2 + Sorafenib 550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
PR104 770 mg/m^2 + Sorafenib 770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
Total Total of all reporting groups

Baseline Measures
    PR104 550 mg/m^2 + Sorafenib     PR104 770 mg/m^2 + Sorafenib     Total  
Number of Participants  
[units: participants]
  8     6     14  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     5     12  
>=65 years     1     1     2  
Age  
[units: years]
Mean ± Standard Deviation
  57  ± 13     59  ± 13     58  ± 13  
Gender  
[units: participants]
     
Female     3     0     3  
Male     5     6     11  
Region of Enrollment  
[units: participants]
     
United States     2     1     3  
Taiwan     5     2     7  
Hong Kong     1     3     4  



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose (MTD) of PR104 When Used in Combination With Standard Dose Sorafenib in the Phase I Population   [ Time Frame: 4 weeks (1 cycle) ]

2.  Secondary:   Safety and Tolerability: Serious Adverse Events   [ Time Frame: 30 days following the last administration of study treatment ]

3.  Secondary:   Pharmacokinetics [Maximum Plasma Concentration (Cmax)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)   [ Time Frame: Day 1 of Cycles 1 and 2 ]

4.  Secondary:   Pharmacokinetics [Half Life (T1/2)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)   [ Time Frame: Day 1 of Cycles 1 and 2 ]

5.  Secondary:   Pharmacokinetics [Area Under the Curve(AUC)] of PR104 and PR104 Metabolites in Cohort 1 (770 mg/m^2 Dose Group)   [ Time Frame: Day 1 of Cycles 1 and 2 ]

6.  Secondary:   Pharmacokinetics (Cmax) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)   [ Time Frame: Day 1 of Cycles 1 and 2 ]

7.  Secondary:   Pharmacokinetics (T1/2) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)   [ Time Frame: Day 1 of Cycles 1 and 2 ]

8.  Secondary:   Pharmacokinetics (AUC) of PR104 and PR104 Metabolites in Cohort 2 (550 mg/m^2 Dose Group)   [ Time Frame: Day 1 of Cycles 1 and 2 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Early termination leading to small numbers of subjects analyzed. Phase II part of study never initiated.


  More Information
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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: Director of Clinical Development
Organization: Proacta, Inc.
phone: 858-642-0386
e-mail: clinicalops@proacta.com


No publications provided


Responsible Party: Proacta, Incorporated
ClinicalTrials.gov Identifier: NCT00862082     History of Changes
Obsolete Identifiers: NCT00838604
Other Study ID Numbers: PR104-2002
Study First Received: March 12, 2009
Results First Received: May 31, 2011
Last Updated: July 19, 2013
Health Authority: United States: Food and Drug Administration