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Study of JI-101 in Patients With Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers

This study has been terminated.
(Lack of drug efficacy)
Sponsor:
Collaborator:
Jubilant Innovation Ltd.
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01149434
First received: June 22, 2010
Last updated: September 24, 2014
Last verified: September 2014
Results First Received: September 8, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cancer
Neuroendocrine
Ovarian Cancer
Colon Cancer
Interventions: Drug: JI-101
Drug: Everolimus

  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
Pharmacokinetic Arm Phase 1

Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)

JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.

Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1).

Pharmacodynamic Arm Phase 2

Patients going on the Pharmacodynamic study will receive JI-101 only.

JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.


Participant Flow:   Overall Study
    Pharmacokinetic Arm Phase 1     Pharmacodynamic Arm Phase 2  
STARTED     4     15  
COMPLETED     4     10  
NOT COMPLETED     0     5  



  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
Pharmacokinetic Arm - Phase 1

Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)

JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.

Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus.

Pharmacokinetic Arm-Phase II

Patients going on the Pharmacodynamic study will receive JI-101 only.

JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.

Total Total of all reporting groups

Baseline Measures
    Pharmacokinetic Arm - Phase 1     Pharmacokinetic Arm-Phase II     Total  
Number of Participants  
[units: participants]
  4     15     19  
Age  
[units: years]
Mean ( Full Range )
  72  
  ( 65 to 80 )  
  60  
  ( 35 to 79 )  
  60  
  ( 35 to 80 )  
Gender  
[units: participants]
     
Female     0     12     12  
Male     4     3     7  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effect of JI 101 on Pharmacokinetics Area Under Curve (AUC) (0-inf) of RAD001   [ Time Frame: pre-dose and at 0.5, 1, 2, 4, 6, 8, 10, and 24 hours after dosing (Cycle 1 Day 1 for RAD001 alone and Cycle 1 Day 8 for RAD001 + JI-101 ]

2.  Primary:   Effect of RAD001 on Pharmacokinetics AUC(0-inf) of JI-101   [ Time Frame: pre-dose and at 0.5, 1, 2, 4, 6, 8, 10, and 24 hours after dosing (Cycle 1 Day 8 for RAD001 + JI101 and Cycle 1 Day 15 for JI-101 alone ]

3.  Primary:   Progression Free-Survival in the Ovarian Cancer Cohort   [ Time Frame: 2 months ]

4.  Primary:   Tumor Response in the Ovarian Cancer Cohort   [ Time Frame: 2 years ]

5.  Secondary:   Safety and Tolerability of JI-101   [ Time Frame: 2 years ]

6.  Secondary:   Tumor Response   [ Time Frame: 2 years ]

7.  Secondary:   Safety and Tolerability of JI-101   [ Time Frame: 2 years ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sunil Sharma, MD
Organization: Huntsman Cancer Institute Unversity of Utah
phone: 801-585-0255
e-mail: sunil.sharma@hci.utah.edu


No publications provided


Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01149434     History of Changes
Other Study ID Numbers: HCI43102
Study First Received: June 22, 2010
Results First Received: September 8, 2014
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration