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Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100 (COMET-1)

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ClinicalTrials.gov Identifier: NCT01605227
Recruitment Status : Completed
First Posted : May 24, 2012
Results First Posted : March 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Exelixis

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Prostate Cancer
Castration Resistant Prostate Cancer
Pain
Prostatic Neoplasms
Interventions: Drug: cabozantinib
Drug: prednisone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled: 02 July 2012 (first subject randomized), Data cut off date: 07 July 2014

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
Cabozantinib

Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.

Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.

Prednisone

Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.

Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.


Participant Flow:   Overall Study
    Cabozantinib   Prednisone
STARTED [1]   682   346 
COMPLETED [2]   61   17 
NOT COMPLETED   621   329 
Did not receive study treatment                2                3 
Adverse Event                228                42 
Progressive Disease                132                128 
Clinical Deterioration                227                133 
Lost to Follow-up                1                0 
Protocol Violation                1                0 
Physician Decision                9                7 
Withdrawal by Subject                18                14 
Sponsor Decision                2                0 
Started New Therapy                1                0 
Subject Decision                0                1 
Dose Held >6 weeks                0                1 
[1] Randomized
[2] Subjects still on study treatment at data cut-off date



  Baseline Characteristics

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
Cabozantinib

Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.

Cabozantinib (XL184) 60 mg tablets orally once daily plus prednisone-matched placebo orally twice daily.

Prednisone

Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.

Prednisone 5 mg capsules orally twice daily plus cabozantinib-matched placebo orally once daily.

Total Total of all reporting groups

Baseline Measures
   Cabozantinib   Prednisone   Total 
Overall Participants Analyzed 
[Units: Participants]
 682   346   1028 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      165  24.2%      97  28.0%      262  25.5% 
>=65 years      517  75.8%      249  72.0%      766  74.5% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      682 100.0%      346 100.0%      1028 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      1   0.3%      1   0.1% 
Asian      2   0.3%      0   0.0%      2   0.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      14   2.1%      6   1.7%      20   1.9% 
White      520  76.2%      265  76.6%      785  76.4% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      146  21.4%      74  21.4%      220  21.4% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
North America   119   63   182 
Europe   528   256   784 
Australia   35   27   62 
Prior cabazitaxel (per CRF) 
[Units: Participants]
Count of Participants
     
Yes      261  38.3%      132  38.2%      393  38.2% 
No      421  61.7%      214  61.8%      635  61.8% 
Brief Pain Inventory (BPI) Item 3 (per CRF) [1] 
[Units: Participants]
Count of Participants
     
<4      389  57.0%      196  56.6%      585  56.9% 
≥4      284  41.6%      148  42.8%      432  42.0% 
Missing      9   1.3%      2   0.6%      11   1.1% 
[1] Pain will be assessed using the BPI Items #3 (worst pain over the last 24 hours by recall).
ECOG Performance Status (per CRF) 
[Units: Participants]
     
0/1 (asymptomatic or symptomatic but ambulatory)   605   303   908 
2 (ambulatory but can't carry out work activities)   76   43   119 
Missing   1   0   1 
Opioid narcotic use within 24 hours (per solicited oploid CRF) 
[Units: Participants]
Count of Participants
 454   228   682 
Concomitant prednisone/prednisolone at randomization 
[Units: Participants]
Count of Participants
 289   142   431 
Time from diagnosis to study entry 
[Units: Years]
Median (Full Range)
 6.68 
 (0.09 to 26.6) 
 6.98 
 (0.04 to 22.2) 
 6.83 
 (0.04 to 26.6) 
Bone scan lesion area 
[Units: Mm^2]
Median (Full Range)
 45,635.5 
 (0 to 388,052) 
 41,746.0 
 (0 to 283,304) 
 44,782.0 
 (0 to 388,052) 
Extent of metastasis 
[Units: Participants]
     
None   0   0   0 
Bone   681   346   1027 
Lymph node   313   140   453 
Visceral   133   58   191 
Liver   91   35   126 
Lung   69   29   98 
Other soft tissue   39   23   62 
No. of prior anticancer agents [1] 
[Units: Participants]
     
 57   31   88 
≥3   625   315   940 
[1] Excluding agents to maintain castration status
Baseline LDH 
[Units: U/L]
Median (Full Range)
 230 
 (59 to 6004) 
 230 
 (87 to 3062) 
 230 
 (59 to 6004) 
Baseline PSA 
[Units: μg/L]
Median (Full Range)
 192 
 (0.02 to 10030) 
 195 
 (0.54 to 10963) 
 192 
 (0 to 10963) 
Baseline serum testosterone (<50 ng/dL) 
[Units: Participants]
Count of Participants
 677   345   1022 


  Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: OS was measured from the time of randomization until 614 events, approximately 24 months after study start ]

2.  Secondary:   Bone Scan Response (BSR)   [ Time Frame: BSR was measured at the end of Week 12 as determined by the IRF ]

3.  Other Pre-specified:   Progression-free Survival (PFS)   [ Time Frame: Duration of PFS was defined as time from the date of randomization to earlier of date of radiographic progression (bone/andor soft tissue) according to the investigator's assessment or death, assessed for up to approximately 24 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Exelixis Medical Information
Organization: Exelixis, Inc.
phone: 855-292-3935
e-mail: druginfo@exelixis.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01605227     History of Changes
Other Study ID Numbers: XL184-307
2012-001834-33 ( EudraCT Number )
First Submitted: May 22, 2012
First Posted: May 24, 2012
Results First Submitted: May 23, 2017
Results First Posted: March 14, 2018
Last Update Posted: March 14, 2018