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Trial record 1 of 2 for:    BNC105P
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BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma

This study has been completed.
Sponsor:
Collaborator:
Bionomics Limited
Information provided by (Responsible Party):
Hoosier Cancer Research Network
ClinicalTrials.gov Identifier:
NCT01034631
First received: December 15, 2009
Last updated: April 17, 2017
Last verified: April 2017
Results First Received: January 25, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Renal Cell Carcinoma
Interventions: Drug: Everolimus
Drug: BNC105P

  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
Phase I Participants Participants in the phase I dose escalation portion of the study.
Phase II: Arm A

Phase II Participants, Arm A

Everolimus 10mg + BNC105P(Phase I MTD)

Phase II: Arm B Participants

Phase II: Arm B Participants

Everolimus 10mg followed by BNC105P monotherapy (16mg/m^2) following progression or intolerable toxicity on Everolimus therapy.


Participant Flow for 2 periods

Period 1:   Phase I
    Phase I Participants   Phase II: Arm A   Phase II: Arm B Participants
STARTED   15   0 [1]   0 [1] 
COMPLETED   12   0   0 
NOT COMPLETED   3   0   0 
Symptomatic Deterioration before Treatme                3                0                0 
[1] No Phase II Participants were enrolled during this time period

Period 2:   Phase II
    Phase I Participants   Phase II: Arm A   Phase II: Arm B Participants
STARTED   0 [1]   70   69 
COMPLETED   0   69   67 
NOT COMPLETED   0   1   2 
Not Evaluable per protocol                0                0                2 
Determined Ineligible per protocol                0                1                0 
[1] No Phase I Participants were enrolled during this time period.



  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
Phase I Participants Participants in the phase I dose escalation portion of the study.
Phase II: Arm A

Phase II Participants, Arm A

Everolimus + BNC105P

Phase II: Arm B Participants

Phase II: Arm B Participants

Everolimus only, followed by BNC105P monotherapy

Total Total of all reporting groups

Baseline Measures
   Phase I Participants   Phase II: Arm A   Phase II: Arm B Participants   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   69   69   153 
Age 
[Units: Years]
Mean (Standard Deviation)
 58  (9)   62  (9)   63  (9)   62  (9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      6  40.0%      20  29.0%      13  18.8%      39  25.5% 
Male      9  60.0%      49  71.0%      56  81.2%      114  74.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      1   1.4%      1   0.7% 
Asian      0   0.0%      5   7.2%      5   7.2%      10   6.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2  13.3%      2   2.9%      4   5.8%      8   5.2% 
White      13  86.7%      61  88.4%      59  85.5%      133  86.9% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      1   1.4%      0   0.0%      1   0.7% 
Initial Karnovksy Performance Score (KPS) [1] 
[Units: Participants]
Count of Participants
       
KPS 100      0   0.0%      29  42.0%      25  36.2%      54  35.3% 
KPS 90      9  60.0%      23  33.3%      24  34.8%      56  36.6% 
KPS 80      2  13.3%      13  18.8%      15  21.7%      30  19.6% 
KPS 70      4  26.7%      4   5.8%      5   7.2%      13   8.5% 
[1] Karnofsky Performance Status (KPS) is a general indicator of a subject's well being and ability to carry on daily activities. The KPS scale ranges from 0-100 in 10 unit increments where 100=Normal; no complaints; no evidence of disease and 0=Dead
Memorial Sloan Kettering Cancer Center Risk Group (MSKCC 
[Units: Participants]
Count of Participants
       
MSKCC Risk Group - Good   3   17   16   36 
MSKCC Risk Group - Intermediate   11   45   47   103 
MSKCC Risk Group - Poor   1   7   6   14 
Metastatic Site 
[Units: Participants]
Count of Participants
       
Lung   13   57   54   124 
Liver   6   13   13   32 
Bone   8   21   24   53 
Brain   2   3   5   10 
Number of Prior Therapies 
[Units: Participants]
Count of Participants
       
1 Prior Therapy   0   14   13   27 
2 Prior Therapies   0   24   18   42 
3 Prior Therapies   3   10   15   28 
>=4 Prior Therapies   12   21   23   56 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Phase I: Maximum Tolerated Dose of BNC105P in Combination With Everolimus.   [ Time Frame: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months ]

2.  Primary:   Phase I: Toxicities of BNC105P in Combination With Everolimus.   [ Time Frame: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months ]

3.  Primary:   Phase II: 6-month Progression Free Survival (PFS) With the Addition of BNC105P to Everolimus.   [ Time Frame: 6 months ]

4.  Secondary:   Phase I: Response Rate of BNC105P in Combination With Everolimus.   [ Time Frame: Until disease progression or unacceptable toxicity, up to 24 cycles or 24 months ]

5.  Secondary:   Geometric Mean Half-life of BNC105 and BNC105P in Combination With Everolimus.   [ Time Frame: 12 months ]

6.  Secondary:   Phase II: Response Rate With Combination Therapy Compared to Everolimus Alone   [ Time Frame: 12 months ]

7.  Secondary:   Phase II: Progression Free Survival (PFS) With BNC105P Alone in Patients After Progressing on Everolimus.   [ Time Frame: 12 months ]

8.  Secondary:   Phase II: Adverse Events of Everolimus and BNC105P When Administered as a Combination or Sequential Regimen.   [ Time Frame: 12 months ]

9.  Secondary:   Phase II: Overall Survival   [ Time Frame: 60 months ]

10.  Secondary:   Exploratory Objective: Correlation of PFS With Biomarkers   [ Time Frame: 6 months ]


  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
No text entered.


  More Information
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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: Clinical Data Coordinator
Organization: Hoosier Cancer Research Network, Inc.
phone: 317-921-2050
e-mail: jsmith@hoosiercancer.org


Publications of Results:
Thomas E. Hutson, Long H. Dang, Richard C. Lauer, Alexander Starodub, Ralph J. Hauke, Matt D. Galsky, Kathryn A. Bylow, Theodore Logan, Charles Lance Cowey, David C. Bibby, Gabriel Kremmidiotis, Elizabeth E. Doolin, Tina C. Lavranos, Guru Sonpavde, Noah M. Hahn, Christopher Sweeney, John Sarantopoulos. Phase I results of a phase I/II trial of BNC105P with everolimus in metastatic renal cell carcinoma (mRCC) patients previously treated with VEGFR tyrosine kinase inhibitors. J Clin Oncol 30, 2012 (suppl; abstr 4603) http://www.asco.org/ASCOv2/Meetings/Abstracts&vmview=abst_detail_view&confID=114&abstractID=91911
John Sarantopoulos, Long H. Dang, Richard C. Lauer, Alexander Starodub, Ralph J. Hauke, Matt D. Galsky, Kathryn A. Bylow, Charles Lance Cowey, David C. Bibby, Gabriel Kremmidiotis, Elizabeth E. Doolin, Tina C. Lavranos, Jose Luis Iglesias, Guru Sonpavde, Theodore Logan, Noah M. Hahn, Christopher Sweeney, Thomas E. Hutson. A phase I/II trial of BNC105P with everolimus in metastatic renal cell carcinoma (mRCC) patients: Updated phase I results of the Disruptor-1 trial. J Clin Oncol 31, 2013 (suppl; abstr 4563. http://abstracts2.asco.org/AbstView_132_107981.html


Responsible Party: Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT01034631     History of Changes
Other Study ID Numbers: HOG GU09-145
Study First Received: December 15, 2009
Results First Received: January 25, 2017
Last Updated: April 17, 2017