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Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer

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: NCT01683994
Recruitment Status : Completed
First Posted : September 12, 2012
Results First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
William Dahut Jr., M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostatic Neoplasms
Interventions Drug: Cabozantinib
Drug: Docetaxel
Drug: Prednisone
Enrollment 49
Recruitment Details  
Pre-assignment Details 49 participants were enrolled on this study. 4 participants were screen failures and were not assigned to any treatment groups. Data is shown for 45/49 participants. 13 participants were assigned to Ph II Arm A Docetaxel & Prednisone but only 12 started treatment; one participant declined to start treatment. Data is shown for 45/49 participants.
Arm/Group Title Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone Ph II Arm A: Docetaxel + Prednisone Ph II Arm B: Cabozantinib + Docetaxel + Prednisone
Hide Arm/Group Description Cycle=21 days; Cabozantinib: 20 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID) Cycle=21 days; Cabozantinib: 40 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID) Cycle=21 days; Cabozantinib: 60 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID) Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg by mouth (PO) twice a day (BID) Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID); Cabozantinib: 40 mg by mouth (PO) everyday (QD)
Period Title: Overall Study
Started 4 8 7 13 13
# of Patients Who Received Treatment 4 8 7 12 13
Completed 3 8 7 10 12
Not Completed 1 0 0 3 1
Reason Not Completed
Withdrawal by Subject             1             0             0             1             0
Intercurrent illness             0             0             0             2             1
Arm/Group Title Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone Ph II Arm A: Docetaxel + Prednisone Ph II Arm B: Cabozantinib + Docetaxel + Prednisone Total
Hide Arm/Group Description Cycle=21 days; Cabozantinib: 20 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID) Cycle=21 days; Cabozantinib: 40 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID) Cycle=21 days; Cabozantinib: 60 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID) Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg by mouth (PO) twice a day (BID) Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID); Cabozantinib: 40 mg by mouth (PO) everyday (QD) Total of all reporting groups
Overall Number of Baseline Participants 4 8 7 13 13 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 7 participants 13 participants 13 participants 45 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  50.0%
2
  25.0%
1
  14.3%
3
  23.1%
5
  38.5%
13
  28.9%
>=65 years
2
  50.0%
6
  75.0%
6
  85.7%
10
  76.9%
8
  61.5%
32
  71.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 8 participants 7 participants 13 participants 13 participants 45 participants
59.45  (11.67) 66.16  (9.51) 70.15  (12.03) 67.72  (8.34) 68.89  (8.46) 67.34  (9.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 7 participants 13 participants 13 participants 45 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
4
 100.0%
8
 100.0%
7
 100.0%
13
 100.0%
13
 100.0%
45
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 7 participants 13 participants 13 participants 45 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
1
   7.7%
2
   4.4%
Not Hispanic or Latino
4
 100.0%
8
 100.0%
6
  85.7%
12
  92.3%
10
  76.9%
40
  88.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.7%
2
  15.4%
3
   6.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 7 participants 13 participants 13 participants 45 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
1
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  25.0%
3
  37.5%
3
  42.9%
5
  38.5%
6
  46.2%
18
  40.0%
White
3
  75.0%
5
  62.5%
3
  42.9%
8
  61.5%
6
  46.2%
25
  55.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   7.7%
1
   2.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants 8 participants 7 participants 13 participants 13 participants 45 participants
4
 100.0%
8
 100.0%
7
 100.0%
13
 100.0%
13
 100.0%
45
 100.0%
Baseline Prostatic-Specific Antigen (PSA)   [1] 
Median (Full Range)
Unit of measure:  Ng/ml
Number Analyzed 4 participants 8 participants 7 participants 13 participants 13 participants 45 participants
182.38
(0.01 to 508.5)
73.71
(8.39 to 225)
166.3
(2.06 to 897.9)
346.9
(94.62 to 2649)
65.6
(4.5 to 3940.38)
118.4
(0.01 to 3940.38)
[1]
Measure Description: PSA normal range is 4 ng/ml or lower.
Prior Treatment with Enzalutamide or Abiraterone  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 8 participants 7 participants 13 participants 13 participants 45 participants
3
  75.0%
5
  62.5%
4
  57.1%
8
  61.5%
5
  38.5%
25
  55.6%
1.Primary Outcome
Title Progression Free Survival (PFS) of Cabozantinib + Docetaxel + Prednisone Compared to Docetaxel + Prednisone Alone
Hide Description PFS is the time interval from start of treatment to documented evidence of disease progression or death. Disease progression was assessed by the Response Criteria in Solid Tumors (RECIST) and is defined as at least a 20% increase in the sum of the diameters of target lesions as referenced by the smallest sum on study. Appearance of one or more new lesions on bone scan and/or two consecutive rising prostatic-specific antigen values above the baseline at a minimum of one week intervals. A normal PSA value is 4.0 ng/ml and lower.
Time Frame From start date of treatment until the date of first documented progression, date of death from any cause and up to 40 months, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
Four participants came off study before restaging. One participant did not start treatment. Forty participants are evaluable for PFS. No participants received carbozantinib after progression from Docetaxel and Prednisone alone.
Arm/Group Title Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone Ph II Arm A: Docetaxel + Prednisone Ph II Arm B: Cabozantinib + Docetaxel + Prednisone
Hide Arm/Group Description:
Cycle=21 days; Cabozantinib: 20 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
Cycle=21 days; Cabozantinib: 40 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
Cycle=21 days; Cabozantinib: 60 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg by mouth (PO) twice a day (BID)
Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID); Cabozantinib: 40 mg by mouth (PO) everyday (QD)
Overall Number of Participants Analyzed 3 8 7 10 12
Median (Full Range)
Unit of Measure: months
8
(2 to 39)
13
(8 to 21)
6
(2 to 13)
10
(1 to 10)
6.5
(2 to 24)
2.Primary Outcome
Title Maximum Tolerated Dose (MTD)
Hide Description MTD is defined as the dose level at which no more than 1 of 6 patients experiences a dose limiting toxicity (DLT) at the level below that which had two instances of DLT. A DLT are defined as adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) occurring during the first two cycles of therapy and related to the study medications (attributions: possible, probable, and definite) while fulfilling one of the following criteria: Any Grade 3 or greater non-hematologic toxicity except asymptomatic grade 3 hypertension, hypomagnesemia, hyponatremia, hypophosphatemia, hypocalcemia, and asymptomatic grade 4 uric acid. A treatment delay of > 2 weeks due to an adverse event (delays due to dental procedures are not included). Grade 4 neutropenia (absolute neutrophil count <500/µL lasting > 5 days. Febrile neutropenia. Grade 3 thrombocytopenia lasting for 7 days or more or thrombocytopenia < 50K/µL requiring platelet transfusion for bleeding.
Time Frame First two cycles of treatment (each cycle is 21 days), approximately 42 days.
Hide Outcome Measure Data
Hide Analysis Population Description
Maximum tolerated dose was assessed only on phase 1 cohort participants. All 19 patients (e.g. 4 participants on dose level 1, 8 participants on dose level 2, and 7 participants on dose level 3) were included in the safety assessment to determine maximum tolerated dose.
Arm/Group Title Ph I Cabozantinib + Docetaxel + Prednisone
Hide Arm/Group Description:
Cycle=21 days; Cabozantinib: 20 mg, 40mg, and 60 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: mg
40
3.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Adverse events were assessed from the date treatment consent signed to date off study, approximately 45 months and 14 days for Arm A; 43 months and 14 days for Arm B; 9 months and 11 days for DL1; 27 months and 1 day for DL2; & 11 months & 25 days for DL3
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in Arm A declined to participate before treatment started.
Arm/Group Title Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone Ph II Arm A: Docetaxel + Prednisone Ph II Arm B: Cabozantinib + Docetaxel + Prednisone
Hide Arm/Group Description:
Cycle=21 days; Cabozantinib: 20 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
Cycle=21 days; Cabozantinib: 40 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
Cycle=21 days; Cabozantinib: 60 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg by mouth (PO) twice a day (BID)
Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID); Cabozantinib: 40 mg by mouth (PO) everyday (QD)
Overall Number of Participants Analyzed 4 8 7 12 13
Measure Type: Count of Participants
Unit of Measure: Participants
4
 100.0%
8
 100.0%
7
 100.0%
12
 100.0%
13
 100.0%
4.Other Pre-specified Outcome
Title Number of Participants With a Dose Limiting Toxicities (DLTs)
Hide Description A DLT are defined as adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) occurring during the first two cycles of therapy and related to the study medications (attributions: possible, probable, and definite) while fulfilling one of the following criteria: Any Grade 3 or greater non-hematologic toxicity except asymptomatic grade 3 hypertension, hypomagnesemia, hyponatremia, hypophosphatemia, hypocalcemia, and asymptomatic grade 4 uric acid. A treatment delay of > 2 weeks due to an adverse event (delays due to dental procedures are not included). Grade 4 neutropenia (absolute neutrophil count <500/µL lasting > 5 days. Febrile neutropenia. Grade 3 thrombocytopenia lasting for 7 days or more or thrombocytopenia < 50K/µL requiring platelet transfusion for bleeding.
Time Frame First two cycles of treatment (each cycle is 21 days), approximately 42 days.
Hide Outcome Measure Data
Hide Analysis Population Description
DLT only pertains to DL1, 2 and 3. Arms A and B did not evaluate for DLT.
Arm/Group Title Ph I Dose Level 1: Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 2: Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 3: Cabozantinib + Docetaxel + Prednisone
Hide Arm/Group Description:
Cycle=21 days; Cabozantinib: 20mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
Cycle=21 days; Cabozantinib: 40mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
Cycle=21 days; Cabozantinib: 60mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
Overall Number of Participants Analyzed 4 8 7
Measure Type: Count of Participants
Unit of Measure: Participants
Neutropenic fever
0
   0.0%
0
   0.0%
1
  14.3%
Palmar plantar erythroderma
0
   0.0%
0
   0.0%
1
  14.3%
5.Other Pre-specified Outcome
Title Number of Participants Achieving Prostatic-Specific Antigen (PSA) Decline of 30% or 50% From Baseline
Hide Description PSA normal range is 4 ng/ml or lower. Participants with PSA decline of 30% or 50% is the measures for prostate cancer based on conventional reporting metrics.
Time Frame up to 38 months
Hide Outcome Measure Data
Hide Analysis Population Description
One participant randomized to Arm A declined to participate before treatment started.
Arm/Group Title Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone Ph II Arm A Docetaxel + Prednisone Ph II Arm B: Cabozantinib + Docetaxel + Prednisone
Hide Arm/Group Description:
Cycle=21 days; Cabozantinib: 20 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
Cycle=21 days; Cabozantinib: 40 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
Cycle=21 days; Cabozantinib: 60 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID)
Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg by mouth (PO) twice a day (BID)
Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg by mouth (PO) twice a day (BID); Cabozantinib: 40mg by mouth (PO) everyday (QD)
Overall Number of Participants Analyzed 3 8 7 12 13
Measure Type: Count of Participants
Unit of Measure: Participants
Decline in PSA>30% from baseline
0
   0.0%
5
  62.5%
5
  71.4%
5
  41.7%
10
  76.9%
Decline in PSA>50% from baseline
0
   0.0%
5
  62.5%
4
  57.1%
3
  25.0%
9
  69.2%
Time Frame Adverse events were assessed from the date treatment consent signed to date off study, approximately 45 months and 14 days for Arm A; 43 months and 14 days for Arm B; 9 months and 11 days for Dose Level 1; 27 months and 1 day for Dose Level 2; and 11 months and 25 days for Dose Level 3.
Adverse Event Reporting Description One participant in Arm/Group A declined to participate before treatment started.
 
Arm/Group Title Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone Ph II Arm A: Docetaxel + Prednisone Ph II Arm B: Cabozantinib + Docetaxel + Prednisone
Hide Arm/Group Description Cycle=21 days; Cabozantinib: 20 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID) Cycle=21 days; Cabozantinib: 40 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID) Cycle=21 days; Cabozantinib: 60 mg by mouth (PO) everyday (QD); Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID) Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg by mouth (PO) twice a day (BID) Cycle=21 days; Docetaxel: 75 mg/m^2 intravenous (IV) over 60 min on day 1; Prednisone: 5 mg PO twice a day (BID); Cabozantinib: 40 mg by mouth (PO) everyday (QD)
All-Cause Mortality
Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone Ph II Arm A: Docetaxel + Prednisone Ph II Arm B: Cabozantinib + Docetaxel + Prednisone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/8 (0.00%)      2/7 (28.57%)      0/12 (0.00%)      1/13 (7.69%)    
Hide Serious Adverse Events
Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone Ph II Arm A: Docetaxel + Prednisone Ph II Arm B: Cabozantinib + Docetaxel + Prednisone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/4 (50.00%)      5/8 (62.50%)      2/7 (28.57%)      3/12 (25.00%)      3/13 (23.08%)    
Blood and lymphatic system disorders           
Anemia  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Cardiac disorders           
Atrial fibrillation  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Heart failure  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Lower gastrointestinal hemorrhage  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Gastric ulcer  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Rectal ulcer  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Oral pain  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
General disorders           
Sudden death NOS  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 1/13 (7.69%)  1
Infusion related reaction  1  1/4 (25.00%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Fever  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Death NOS  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Infections and infestations           
Anorectal infection  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 1/13 (7.69%)  1
Appendicitis  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Lung infection  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Skin infection  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Investigations           
Febrile neutropenia  1  0/4 (0.00%)  0 2/8 (25.00%)  2 2/7 (28.57%)  2 0/12 (0.00%)  0 1/13 (7.69%)  1
Neutrophil count decreased  1  2/4 (50.00%)  4 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Metabolism and nutrition disorders           
Dehydration  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Hyperglycemia  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  2 0/13 (0.00%)  0
Hypoglycemia  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Nervous system disorders           
Transient ischemic attacks  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Surgical and medical procedures           
Thromboembolic event  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 1/13 (7.69%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ph I Dose Level 1:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 2:Cabozantinib + Docetaxel + Prednisone Ph I Dose Level 3:Cabozantinib + Docetaxel + Prednisone Ph II Arm A: Docetaxel + Prednisone Ph II Arm B: Cabozantinib + Docetaxel + Prednisone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      8/8 (100.00%)      7/7 (100.00%)      12/12 (100.00%)      13/13 (100.00%)    
Blood and lymphatic system disorders           
Anemia  1  0/4 (0.00%)  0 3/8 (37.50%)  11 1/7 (14.29%)  1 4/12 (33.33%)  5 1/13 (7.69%)  1
Cardiac disorders           
Atrial fibrillation  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  3 0/13 (0.00%)  0
Palpitations  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Sinus tachycardia  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Ear and labyrinth disorders           
Vertigo  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Eye disorders           
Watering eyes  1  1/4 (25.00%)  1 1/8 (12.50%)  1 1/7 (14.29%)  1 1/12 (8.33%)  1 2/13 (15.38%)  2
Blurred vision  1  1/4 (25.00%)  1 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Periorbital edema  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Gastrointestinal disorders           
Bloating  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Constipation  1  1/4 (25.00%)  1 3/8 (37.50%)  4 2/7 (28.57%)  2 2/12 (16.67%)  2 1/13 (7.69%)  1
Diarrhea  1  1/4 (25.00%)  3 6/8 (75.00%)  9 2/7 (28.57%)  3 3/12 (25.00%)  3 5/13 (38.46%)  7
Duodenal ulcer  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Gastroparesis  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Nausea  1  1/4 (25.00%)  1 5/8 (62.50%)  8 4/7 (57.14%)  5 2/12 (16.67%)  2 4/13 (30.77%)  4
Proctitis  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Rectal hemorrhage  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 1/12 (8.33%)  1 0/13 (0.00%)  0
Vomiting  1  2/4 (50.00%)  3 4/8 (50.00%)  6 2/7 (28.57%)  3 1/12 (8.33%)  1 1/13 (7.69%)  1
Abdominal distension  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Colitis  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 2/13 (15.38%)  3
Dyspepsia  1  2/4 (50.00%)  3 2/8 (25.00%)  2 1/7 (14.29%)  1 0/12 (0.00%)  0 1/13 (7.69%)  1
Mucositis oral  1  1/4 (25.00%)  1 6/8 (75.00%)  11 3/7 (42.86%)  5 0/12 (0.00%)  0 2/13 (15.38%)  2
Oral dysesthesia  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Oral pain  1  0/4 (0.00%)  0 4/8 (50.00%)  4 2/7 (28.57%)  3 0/12 (0.00%)  0 4/13 (30.77%)  5
Rectal pain  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Rectal perforation  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Rectal ulcer  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Abdominal pain  1  1/4 (25.00%)  1 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Dry mouth  1  1/4 (25.00%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Fecal incontinence  1  1/4 (25.00%)  1 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Flatulence  1  1/4 (25.00%)  1 1/8 (12.50%)  1 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Gingival pain  1  1/4 (25.00%)  2 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Gastroesophageal reflux disease  1  0/4 (0.00%)  0 2/8 (25.00%)  3 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Toothache  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Gastritis  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
General disorders           
Chills  1  1/4 (25.00%)  1 1/8 (12.50%)  1 1/7 (14.29%)  1 1/12 (8.33%)  1 1/13 (7.69%)  1
Fatigue  1  2/4 (50.00%)  2 5/8 (62.50%)  5 2/7 (28.57%)  3 6/12 (50.00%)  8 3/13 (23.08%)  3
Gait disturbance  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Infusion related reaction  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 1/12 (8.33%)  1 0/13 (0.00%)  0
Infusion site extravasation  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Malaise  1  1/4 (25.00%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Pain  1  1/4 (25.00%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 2/12 (16.67%)  3 1/13 (7.69%)  1
Fever  1  0/4 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1 0/12 (0.00%)  0 2/13 (15.38%)  2
Edema limbs  1  0/4 (0.00%)  0 5/8 (62.50%)  8 1/7 (14.29%)  1 0/12 (0.00%)  0 1/13 (7.69%)  1
Infections and infestations           
Nail infection  1  1/4 (25.00%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Gum infection  1  1/4 (25.00%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Upper respiratory infection  1  1/4 (25.00%)  2 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 2/13 (15.38%)  2
Urinary tract infection  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Lung infection  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Skin infection  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Mucosal infection  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Injury, poisoning and procedural complications           
Fall  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Fracture  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 1/12 (8.33%)  1 0/13 (0.00%)  0
Burn  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Bruising  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Infusion site extravasation  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Investigations           
Blood bilirubin increased  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
GGT increased  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  2 0/13 (0.00%)  0
Lipase increased  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  6 1/13 (7.69%)  3
Lymphocyte count decreased  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Platelet count decreased  1  1/4 (25.00%)  2 1/8 (12.50%)  1 0/7 (0.00%)  0 2/12 (16.67%)  2 0/13 (0.00%)  0
Serum amylase increased  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  10 1/13 (7.69%)  5
Weight gain  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  2 0/13 (0.00%)  0
Weight loss  1  0/4 (0.00%)  0 6/8 (75.00%)  10 2/7 (28.57%)  2 1/12 (8.33%)  1 2/13 (15.38%)  3
Alanine aminotransferase increased  1  2/4 (50.00%)  2 2/8 (25.00%)  2 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Neutrophil count decreased  1  3/4 (75.00%)  7 7/8 (87.50%)  16 4/7 (57.14%)  6 0/12 (0.00%)  0 0/13 (0.00%)  0
Aspartate aminotransferase increased  1  1/4 (25.00%)  2 2/8 (25.00%)  2 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Creatinine increased  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
White blood cell decreased  1  1/4 (25.00%)  4 3/8 (37.50%)  8 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Metabolism and nutrition disorders           
Anorexia  1  0/4 (0.00%)  0 4/8 (50.00%)  5 3/7 (42.86%)  3 3/12 (25.00%)  3 5/13 (38.46%)  5
Dehydration  1  0/4 (0.00%)  0 3/8 (37.50%)  3 2/7 (28.57%)  3 1/12 (8.33%)  1 2/13 (15.38%)  2
Hypercalcemia  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Hyperglycemia  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Hypophosphatemia  1  2/4 (50.00%)  12 5/8 (62.50%)  6 1/7 (14.29%)  9 1/12 (8.33%)  1 1/13 (7.69%)  2
Hypocalcemia  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Hypokalemia  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Hypomagnesemia  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Hypoalbuminemia  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Hypoglycemia  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Hyponatremia  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 2/12 (16.67%)  2 1/13 (7.69%)  1
Back pain  1  1/4 (25.00%)  1 1/8 (12.50%)  1 0/7 (0.00%)  0 2/12 (16.67%)  2 2/13 (15.38%)  2
Flank pain  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 1/12 (8.33%)  1 0/13 (0.00%)  0
Generalized muscle weakness  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 2/12 (16.67%)  2 0/13 (0.00%)  0
Muscle weakness lower limb  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Myalgia  1  0/4 (0.00%)  0 4/8 (50.00%)  4 0/7 (0.00%)  0 2/12 (16.67%)  2 4/13 (30.77%)  4
Chest wall pain  1  1/4 (25.00%)  1 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, specify  1 [1]  1/4 (25.00%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Neck edema  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Osteonecrosis of jaw  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Bone pain  1  0/4 (0.00%)  0 1/8 (12.50%)  2 2/7 (28.57%)  4 0/12 (0.00%)  0 0/13 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1 [2]  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Nervous system disorders           
Dizziness  1  1/4 (25.00%)  1 2/8 (25.00%)  2 3/7 (42.86%)  4 1/12 (8.33%)  1 0/13 (0.00%)  0
Dysgeusia  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 7/12 (58.33%)  7 8/13 (61.54%)  8
Paresthesia  1  0/4 (0.00%)  0 4/8 (50.00%)  4 2/7 (28.57%)  6 4/12 (33.33%)  4 0/13 (0.00%)  0
Peripheral sensory neuropathy  1  1/4 (25.00%)  1 2/8 (25.00%)  2 3/7 (42.86%)  3 2/12 (16.67%)  2 0/13 (0.00%)  0
Headache  1  1/4 (25.00%)  1 1/8 (12.50%)  2 2/7 (28.57%)  2 0/12 (0.00%)  0 3/13 (23.08%)  3
Nervous system disorders - Other, neuropathy  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Presyncope  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Syncope  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Movements involuntary  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Tremor  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Psychiatric disorders           
Confusion  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Insomnia  1  0/4 (0.00%)  0 1/8 (12.50%)  1 2/7 (28.57%)  2 0/12 (0.00%)  0 0/13 (0.00%)  0
Renal and urinary disorders           
Urinary incontinence  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Urinary tract obstruction  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Urinary tract pain  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Reproductive system and breast disorders           
Testicular pain  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Genital edema  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Gynecomastia  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Pelvic pain  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Allergic rhinitis  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Hoarseness  1  0/4 (0.00%)  0 2/8 (25.00%)  2 1/7 (14.29%)  1 1/12 (8.33%)  1 1/13 (7.69%)  1
Postnasal drip  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Bronchial obstruction  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Cough  1  1/4 (25.00%)  1 1/8 (12.50%)  2 0/7 (0.00%)  0 0/12 (0.00%)  0 3/13 (23.08%)  3
Dyspnea  1  0/4 (0.00%)  0 1/8 (12.50%)  1 2/7 (28.57%)  2 0/12 (0.00%)  0 2/13 (15.38%)  2
Epistaxis  1  1/4 (25.00%)  1 6/8 (75.00%)  7 3/7 (42.86%)  3 0/12 (0.00%)  0 8/13 (61.54%)  8
Nasal congestion  1  1/4 (25.00%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Productive cough  1  1/4 (25.00%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Voice alteration  1  1/4 (25.00%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Pleuritic pain  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Sore throat  1  1/4 (25.00%)  1 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Skin and subcutaneous tissue disorders           
Alopecia  1  2/4 (50.00%)  2 4/8 (50.00%)  5 2/7 (28.57%)  2 3/12 (25.00%)  3 7/13 (53.85%)  7
Nail discoloration  1  1/4 (25.00%)  1 0/8 (0.00%)  0 1/7 (14.29%)  1 1/12 (8.33%)  1 3/13 (23.08%)  3
Nail loss  1  1/4 (25.00%)  1 3/8 (37.50%)  3 0/7 (0.00%)  0 1/12 (8.33%)  1 2/13 (15.38%)  2
Pruritus  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Nail ridging  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Palmar-plantar erythrodysesthesia syndrome  1  2/4 (50.00%)  2 7/8 (87.50%)  26 3/7 (42.86%)  4 0/12 (0.00%)  0 6/13 (46.15%)  8
Skin and subcutaneous tissue disorders - Other, skin discoloration  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Skin hypopigmentation  1  0/4 (0.00%)  0 0/8 (0.00%)  0 4/7 (57.14%)  6 0/12 (0.00%)  0 4/13 (30.77%)  14
Scalp pain  1  1/4 (25.00%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, dermatitis-eye  1  1/4 (25.00%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Skin ulceration  1  1/4 (25.00%)  1 1/8 (12.50%)  4 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Dry skin  1  1/4 (25.00%)  1 2/8 (25.00%)  2 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Papulopustular rash  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Purpura  1  0/4 (0.00%)  0 1/8 (12.50%)  1 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Rash maculo-papular  1  0/4 (0.00%)  0 2/8 (25.00%)  2 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, petechiae  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Skin atrophy  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Skin hyperpigmentation  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Pain of skin  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  4 0/12 (0.00%)  0 0/13 (0.00%)  0
Rash acneiform  1  0/4 (0.00%)  0 1/8 (12.50%)  1 2/7 (28.57%)  2 0/12 (0.00%)  0 0/13 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, R. thigh lesion  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, dermatitis-hand  1  1/4 (25.00%)  1 0/8 (0.00%)  0 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Vascular disorders           
Thromboembolic event  1  0/4 (0.00%)  0 0/8 (0.00%)  0 2/7 (28.57%)  2 1/12 (8.33%)  1 0/13 (0.00%)  0
Vascular disorders - Other, peripheral vascular disease  1  0/4 (0.00%)  0 0/8 (0.00%)  0 0/7 (0.00%)  0 1/12 (8.33%)  1 0/13 (0.00%)  0
Flushing  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 0/13 (0.00%)  0
Hypotension  1  0/4 (0.00%)  0 1/8 (12.50%)  1 0/7 (0.00%)  0 0/12 (0.00%)  0 1/13 (7.69%)  1
Hypertension  1  0/4 (0.00%)  0 1/8 (12.50%)  1 2/7 (28.57%)  2 0/12 (0.00%)  0 0/13 (0.00%)  0
Hypotension  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
Vascular disorders - Other, vasculopathy  1  0/4 (0.00%)  0 0/8 (0.00%)  0 1/7 (14.29%)  1 0/12 (0.00%)  0 0/13 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
Burning sensation in legs/bones
[2]
Extraosseous extension
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
Layout table for Results Point of Contact information
Name/Title: Dr. William Dahut
Organization: National Cancer Institute
Phone: 240-760-6070
EMail: william_dahut@nih.gov
Publications of Results:
A phase I and randomized phase II study of cabozantinib plus docetaxel and prednisone (C+DP) versus docetaxel and prednisone (DP) alone in metastatic castrate-resistant prostate cancer (mCRPC). Munjid Al Harthy, Ravi Amrit Madan, Fatima Karzai, Daniel Peter Petrylak, Joseph W. Kim, Philip M. Arlen, Marc Robert Theoret, Jenn Marte, Marijo Bilusic, Anna Couvillon, Guinevere Chun, Helen Owens, Amy Hankin, Lisa M. Cordes, William Douglas Figg, James L. Gulley, and William L. Dahut Journal of Clinical Oncology 2019 37:7_suppl, 173-173
Layout table for additonal information
Responsible Party: William Dahut Jr., M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01683994    
Other Study ID Numbers: 120204
12-C-0204
First Submitted: September 8, 2012
First Posted: September 12, 2012
Results First Submitted: August 27, 2019
Results First Posted: November 8, 2019
Last Update Posted: November 8, 2019