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Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer (COMET-2)

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: NCT01522443
Recruitment Status : Terminated (Stopped after the outcome of cabozantinib Phase 3 CRPC study XL184-307.)
First Posted : January 31, 2012
Results First Posted : May 23, 2018
Last Update Posted : May 23, 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: mitoxantrone
Drug: prednisone
Enrollment 119
Recruitment Details First patient enrolled: 15 March 2012, Data cut off date: 06 October 2014. The study was terminated by the Sponsor after 119 subjects were enrolled which was less than the planned sample size of 246 subjects.
Pre-assignment Details  
Arm/Group Title Cabozantinib Mitoxantrone/Prednisone
Hide Arm/Group Description

Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.

Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.

Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.

Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.

Period Title: Overall Study
Started [1] 61 58
Completed [2] 8 3
Not Completed 53 55
Reason Not Completed
No longer receiving clinical benefit             36             28
Adverse Event             10             15
Withdrawal by Subject             5             8
No study treatment given             1             1
Other             1             3
[1]
Randomized
[2]
Subjects still on study treatment at data cut-off date
Arm/Group Title Cabozantinib Mitoxantrone/Prednisone Total
Hide Arm/Group Description

Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.

Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.

Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.

Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.

Total of all reporting groups
Overall Number of Baseline Participants 61 58 119
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
<65 years 24 26 50
65 to <75 years 30 26 56
75 to <85 years 7 6 13
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
61
 100.0%
58
 100.0%
119
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
Hispanic or Latino
2
   3.3%
0
   0.0%
2
   1.7%
Not Hispanic or Latino
57
  93.4%
57
  98.3%
114
  95.8%
Unknown or Not Reported
2
   3.3%
1
   1.7%
3
   2.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
American Indian/Alaska Native 1 0 1
Asian 1 3 4
Black/African-American 8 3 11
Multiple 1 0 1
White 49 51 100
Not Reported 0 1 1
Other 1 0 1
Geographic Region  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
North America 44 36 80
Europe 8 13 21
Asia 9 9 18
ECOG Performance Status (per IVRS/IWRS)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
0-1 (normal to symptoms, but ambulatory) 53 52 105
≥2 (ambulatory to incapable of self-care/death) 8 6 14
Randomization Stratification Factors (per IVRS/IWRS)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
ECOG = 0-1 and prior cabazitaxel: yes 18 18 36
ECOG = 0-1 and prior cabazitaxel: no 35 34 69
ECOG ≥ 2 and prior cabazitaxel: yes 7 6 13
ECOG ≥ 2 and prior cabazitaxel: no 1 0 1
Time from initial diagnosis to randomization  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 61 participants 58 participants 119 participants
4.7
(0 to 18)
5.3
(0 to 16)
5.0
(0 to 18)
Gleason score at diagnosis (Primary + Secondary)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
<7 2 4 6
7 17 21 38
>7 40 28 68
Unknown 2 4 6
Missing 0 1 1
[1]
Measure Description: The Gleason score is used to define prostate cancer prognosis by histologic grading with scores ranging from 2 to 10. A higher Gleason score indicates a more aggressive form of prostate cancer with a worse prognosis.
Prior prostate surgery/procedure   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
Transurethral resection of the prostate (TURP) 8 6 14
Radical prostatectomy - with 17 13 30
Radical prostatectomy - without 3 2 5
Cyrosurgery 0 1 1
Bilateral orchiectomy 4 2 6
Other 55 52 107
[1]
Measure Description: Baseline radical prostatectomy with and without retropubic with pelvic lymphadenectomy measures are provided.
Bone-scan lesion area (BSLA)  
Median (Full Range)
Unit of measure:  Mm^2
Number Analyzed 61 participants 58 participants 119 participants
72865.0
(0 to 251469)
72702.5
(679 to 281936)
72865.0
(0 to 281936)
Sites of prostate cancer metastasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
Bone 61 58 119
Lymph node 29 18 47
Visceral (soft tissue; liver) 8 8 16
Visceral (soft tissue; lung) 2 5 7
Other soft tissue 7 3 10
Pain score (BPI Item 3) during Run-In Stage   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 61 participants 58 participants 119 participants
6.00
(4.0 to 8.0)
6.14
(4.0 to 8.0)
6.00
(4.0 to 8.0)
[1]
Measure Description: During the Run-In State, subjects will self-report pain by phone via an interactive voice response system (IVRS) daily for 7 days and record analgesic medication information on a paper pain medication diary. Each day of the reporting periods, subjects will report their worst pain intensity and their average pain intensity over a 24-hour period using an 11-point numerical rating system (NRS) (ranging from 0 to 10, with 0 representing “No Pain,” and 10 representing “Pain as Bad as You Can Imagine”).
Pain score (BPI Item 3) during Run-In Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
4-5 10 15 25
>5-6 22 13 35
>6-7 18 15 33
>7-8 11 15 26
[1]
Measure Description: During the Run-In State, subjects will self-report pain by phone via an interactive voice response system (IVRS) daily for 7 days and record analgesic medication information on a paper pain medication diary. Each day of the reporting periods, subjects will report their worst pain intensity and their average pain intensity over a 24-hour period using an 11-point numerical rating system (NRS) (ranging from 0 to 10, with 0 representing “No Pain,” and 10 representing “Pain as Bad as You Can Imagine”).
Number of prior anticancer agents  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
2
0
   0.0%
3
   5.2%
3
   2.5%
3
6
   9.8%
4
   6.9%
10
   8.4%
4
20
  32.8%
14
  24.1%
34
  28.6%
≥5
35
  57.4%
37
  63.8%
72
  60.5%
Prior cabazitaxel (per IVRS/IWRS)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 58 participants 119 participants
Yes
25
  41.0%
24
  41.4%
49
  41.2%
No
36
  59.0%
34
  58.6%
70
  58.8%
1.Primary Outcome
Title Pain Response at Week 6 Confirmed at Week 12, Week 12 Reported
Hide Description The pre-specified primary analysis of Pain Response at Week 6 confirmed at Week 12 was defined as ≥ 30% from baseline in the average daily worst pain intensity score during a 7-day reporting period, with neither a concomitant increase in average daily use of any opioid narcotic type, nor addition of any new opioid narcotic type, relative to baseline. Pain Progression at a given time point is defined as ≥ 30% increase compared with baseline in the average daily worst pain intensity score during a 7-day reporting period or either an increase in the average daily use of any type of opioid narcotic or addition of a new opioid narcotic type compared with baseline.
Time Frame Pain response was measured at Week 6 and Week 12 by self-reports of subjects
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis of pain response was based on the Intent to Treat (ITT) population of 119 participants (61 cabozantinib, 58 mitoxantrone plus prednisone).
Arm/Group Title Cabozantinib Mitoxantrone/Prednisone
Hide Arm/Group Description:

Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.

Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.

Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.

Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.

Overall Number of Participants Analyzed 61 58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
15
(5.9 to 24)
17
(7.5 to 27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cabozantinib, Mitoxantrone/Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.773
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments The Cochran-Mantel-Haenszel (CMH) was stratified by the Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.
2.Secondary Outcome
Title Bone Scan Response (BSR)
Hide Description BSR is defined as >=30% in the bone scan lesion area (BSLA) compared with baseline. Bones scans were evaluated by an independent radiology facility (IRF) for response.
Time Frame BSR was measured at the end of Week 12 as determined by the IRF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on the randomized ITT population (61 cabozantinib, 58 mitoxantrone plus prednisone) for BSR at Week 12.
Arm/Group Title Cabozantinib Mitoxantrone/Prednisone
Hide Arm/Group Description:

Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.

Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.

Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.

Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.

Overall Number of Participants Analyzed 61 58
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
31
(20 to 43)
5.2
(0 to 11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cabozantinib, Mitoxantrone/Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments The Cochran-Mantel-Haenszel (CMH) Test was stratified by baslined Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from randomization to the date of death (due to any cause). Participants that had not died were censored at last known date alive. The analyses for OS occurred after 78/196 deaths (40% of the total required for the pre-specified primary analysis of OS). The data cut-off date was 06 October 2014. Median OS was calculated using Kaplan-Meier estimates.
Time Frame OS was measured at the time of randomization until 78 deaths
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent to Treat (ITT) population was used and included 119 randomized subjects (61 cabozantinib, 58 mitoxantrone plus prednisone) at the time of primary analysis (data cut off date: 06 October 2014).
Arm/Group Title Cabozantinib Mitoxantrone/Prednisone
Hide Arm/Group Description:

Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.

Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.

Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.

Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.

Overall Number of Participants Analyzed 61 58
Median (95% Confidence Interval)
Unit of Measure: months
9.0
(6.80 to 11.56)
7.9
(5.26 to 9.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cabozantinib, Mitoxantrone/Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.121
Comments [Not Specified]
Method Log Rank
Comments The Log-Rank Test was stratified by baseline Eastern Cooperative Oncology Group performance status and prior cabazitaxel use.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.44 to 1.10
Estimation Comments [Not Specified]
Time Frame Up to 95 weeks
Adverse Event Reporting Description The safety data includes subjects who were randomized and treated with at least one dose of the study treatment. Of 119 patients, 61 were randomized to receive cabozantinib and 58 mitoxantrone plus prednisone. The Safety population included 117 subjects (60 cabozantinib, 57 mitoxantrone plus prednisone).
 
Arm/Group Title Cabozantinib Mitoxantrone/Prednisone
Hide Arm/Group Description

Subjects randomized to the cabozantinib arm will also receive placebo mitoxantrone injections (color-matched with methylene blue) and placebo prednisone capsules.

Cabozantinib (XL184) 60 mg tablets taken orally once daily and mitoxantrone-matched placebo infusion every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.

Subjects randomized to the mitoxantrone + prednisone arm will also receive placebo cabozantinib tablets.

Mitoxantrone (12mg/m^2) given by IV once every 3 weeks (maximum of 10 infusions) plus prednisone-matched placebo capsules orally twice daily.

All-Cause Mortality
Cabozantinib Mitoxantrone/Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cabozantinib Mitoxantrone/Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   16/60 (26.67%)   15/57 (26.32%) 
Blood and lymphatic system disorders     
Anaemia  1  1/60 (1.67%)  0/57 (0.00%) 
Febrile neutropenia  1  0/60 (0.00%)  4/57 (7.02%) 
Neutropenia  1  0/60 (0.00%)  3/57 (5.26%) 
Gastrointestinal disorders     
Abdominal pain  1  0/60 (0.00%)  2/57 (3.51%) 
Diarrhoea  1  1/60 (1.67%)  1/57 (1.75%) 
Large intestine perforation  1  1/60 (1.67%)  0/57 (0.00%) 
Nausea  1  2/60 (3.33%)  1/57 (1.75%) 
Vomiting  1  1/60 (1.67%)  1/57 (1.75%) 
General disorders     
Asthenia  1  1/60 (1.67%)  1/57 (1.75%) 
Malaise  1  1/60 (1.67%)  0/57 (0.00%) 
Pyrexia  1  1/60 (1.67%)  1/57 (1.75%) 
Infections and infestations     
Cellulitis  1  0/60 (0.00%)  1/57 (1.75%) 
Gastroenteritis viral  1  1/60 (1.67%)  0/57 (0.00%) 
Neutropenic sepsis  1  0/60 (0.00%)  1/57 (1.75%) 
Pneumonia  1  2/60 (3.33%)  1/57 (1.75%) 
Investigations     
Hepatic enzyme increased  1  1/60 (1.67%)  0/57 (0.00%) 
Liver function test abnormal  1  1/60 (1.67%)  0/57 (0.00%) 
Neutrophil count decreased  1  0/60 (0.00%)  1/57 (1.75%) 
Platelet count decreased  1  1/60 (1.67%)  0/57 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  0/60 (0.00%)  1/57 (1.75%) 
Failure to thrive  1  0/60 (0.00%)  1/57 (1.75%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  1/60 (1.67%)  0/57 (0.00%) 
Nervous system disorders     
Depressed level of consciousness  1  1/60 (1.67%)  0/57 (0.00%) 
Hypoaesthesia  1  1/60 (1.67%)  0/57 (0.00%) 
Syncope  1  1/60 (1.67%)  0/57 (0.00%) 
Psychiatric disorders     
Confusional state  1  1/60 (1.67%)  0/57 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  2/60 (3.33%)  2/57 (3.51%) 
Vascular disorders     
Deep vein thrombosis  1  1/60 (1.67%)  0/57 (0.00%) 
Hypertension  1  1/60 (1.67%)  0/57 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cabozantinib Mitoxantrone/Prednisone
Affected / at Risk (%) Affected / at Risk (%)
Total   60/60 (100.00%)   57/57 (100.00%) 
Endocrine disorders     
Hypothyroidism  1  6/60 (10.00%)  1/57 (1.75%) 
Gastrointestinal disorders     
Nausea  1  38/60 (63.33%)  24/57 (42.11%) 
Diarrhoea  1  27/60 (45.00%)  17/57 (29.82%) 
Constipation  1  24/60 (40.00%)  19/57 (33.33%) 
Vomiting  1  23/60 (38.33%)  19/57 (33.33%) 
Dyspepsia  1  9/60 (15.00%)  4/57 (7.02%) 
Oral pain  1  7/60 (11.67%)  1/57 (1.75%) 
Glossodynia  1  4/60 (6.67%)  0/57 (0.00%) 
Retching  1  3/60 (5.00%)  0/57 (0.00%) 
General disorders     
Fatigue  1  34/60 (56.67%)  27/57 (47.37%) 
Asthenia  1  14/60 (23.33%)  4/57 (7.02%) 
Sinusitis  1  3/60 (5.00%)  0/57 (0.00%) 
Investigations     
Weight decreased  1  25/60 (41.67%)  8/57 (14.04%) 
Aspartate aminotransferase increased  1  12/60 (20.00%)  2/57 (3.51%) 
Alanine aminotransferase increased  1  10/60 (16.67%)  0/57 (0.00%) 
Blood alkaline phosphatase increased  1  8/60 (13.33%)  2/57 (3.51%) 
Neutrophil count decreased  1  6/60 (10.00%)  2/57 (3.51%) 
Lymphocyte count decreased  1  4/60 (6.67%)  0/57 (0.00%) 
Blood bilirubin increased  1  3/60 (5.00%)  0/57 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  28/60 (46.67%)  23/57 (40.35%) 
Hypokalaemia  1  13/60 (21.67%)  4/57 (7.02%) 
Hypomagnesaemia  1  8/60 (13.33%)  1/57 (1.75%) 
Hyponatraemia  1  6/60 (10.00%)  2/57 (3.51%) 
Musculoskeletal stiffness  1  3/60 (5.00%)  0/57 (0.00%) 
Psychiatric disorders     
Depression  1  14/60 (23.33%)  8/57 (14.04%) 
Insomnia  1  9/60 (15.00%)  5/57 (8.77%) 
Depressed mood  1  3/60 (5.00%)  0/57 (0.00%) 
Renal and urinary disorders     
Proteinuria  1  4/60 (6.67%)  0/57 (0.00%) 
Urinary retention  1  3/60 (5.00%)  0/57 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dysphonia  1  10/60 (16.67%)  1/57 (1.75%) 
Oropharyngeal pain  1  8/60 (13.33%)  1/57 (1.75%) 
Dyspnoea exertional  1  3/60 (5.00%)  0/57 (0.00%) 
Skin and subcutaneous tissue disorders     
Dry skin  1  9/60 (15.00%)  3/57 (5.26%) 
Palmar-plantar erythrodysaesthesia syndrome  1  9/60 (15.00%)  0/57 (0.00%) 
Skin ulcer  1  6/60 (10.00%)  0/57 (0.00%) 
Blister  1  3/60 (5.00%)  0/57 (0.00%) 
Erythema  1  3/60 (5.00%)  0/57 (0.00%) 
Petechiae  1  3/60 (5.00%)  0/57 (0.00%) 
Skin discolouration  1  3/60 (5.00%)  0/57 (0.00%) 
Vascular disorders     
Hypertension  1  18/60 (30.00%)  0/57 (0.00%) 
Pallor  1  3/60 (5.00%)  0/57 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Enrollment was stopped before planned study population size of 246 was reached (only 119 enrolled).
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.
Our agreements with investigators vary; constant is our right to review results communications prior to public release, and embargo communications for a period of ≤60 days from submittal for review. We do not prohibit investigators from publishing, but we may require previously undisclosed confidential information, other than study results, to be removed from publications, and single-center publications are postponed until after publication of the trial’s primary multicenter publication.
Results Point of Contact
Name/Title: Exelixis Medical Information
Organization: Exelixis, Inc.
Phone: 855-292-3935
Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01522443     History of Changes
Other Study ID Numbers: XL184-306
First Submitted: January 13, 2012
First Posted: January 31, 2012
Results First Submitted: May 23, 2017
Results First Posted: May 23, 2018
Last Update Posted: May 23, 2018