Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01630590
Collaborator
Exelixis (Industry), High Impact Clinical Research Support Program (Other)
62
1
1
86.9
0.7

Study Details

Study Description

Brief Summary

The goal of this clinical research study is learn if adding cabozantinib (also known as XL184) to hormonal therapy can help to control prostate cancer. The safety of this drug will also be studied.

Cabozantinib is designed to block certain proteins in your blood that cause cancer cells to grow. This may cause cancer cells to die.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take 1 capsule of cabozantinib by mouth 1 time every day while you are on study. You should not eat or drink anything other than water for 2 hours before and 1 hour after taking the study drug. You should take the capsule with at least 1 cup (8 ounces) of water. You will also be given separate directions about how to take the study drug.

You will also receive hormone therapy. The hormone drug you receive will be standard of care hormone therapy. The study doctor will decide what hormone therapy you will receive and will explain when and how you should take the hormone therapy, as well as its risks.

You will be given a drug diary where you will record when you take cabozantinib. You should return this diary to the study staff when you come into the clinic.

Study Visits:

At every visit, you will be asked about any side effects you may have had and any other drugs you may be taking.

If you are receiving Coumadin, every week for the first 3 weeks, you will have blood drawn (about 1 teaspoon) to test your blood clotting function.

Every 3 weeks for the first 12 weeks of the study, and then every 6 weeks after that:
  • You will have a physical exam.

  • Blood (about 3-4 teaspoons) will be drawn for routine tests.

Every 3 weeks for the first 12 weeks of the study, and then every 12 weeks after that, blood (about 1 teaspoon) will be drawn to check your thyroid and pancreatic function. The frequency of the testing may change if the study doctor thinks it is needed.

Every 6 weeks, you will have the following tests performed:
  • Blood (about 2-3 teaspoons) will be drawn to measure your PSA levels and for biomarker testing.

  • Urine will be collected for routine tests.

  • You may have these test performed near your home if the study doctor thinks you are tolerating the treatment.

Every 12 weeks, you will have a bone scan and CT scans of the chest, abdomen, and pelvis to check the status of the disease.

Length of Study:

You may continue receiving the study drug for as long as the study doctor thinks it is in your best interest. You will be taken off study early if the disease gets worse, if you have intolerable side effects, or if your study doctor thinks it is in your best interest to stop.

Long-Term Follow-Up:

You will be contacted every 6 months after you stop taking the study drug to check on how you are feeling and the status of the disease. This will consist of a phone call, e-mail, or medical record review. If you are called, each call should last about 5 minutes.

This is an investigational study. Cabozantinib is FDA approved to treat patients with certain types of thyroid cancer. Its use in this study is investigational.

Up to 60 participants will take part in this study. All will be enrolled at MD Anderson.

Study Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Observational Study of XL-184 Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer
Actual Study Start Date :
Jan 8, 2014
Actual Primary Completion Date :
Apr 6, 2021
Actual Study Completion Date :
Apr 6, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cabozantinib + Androgen Ablation Therapy

Patients receive Cabozantinib at starting dose of 60 mg by mouth every day. Study cycles 3 weeks in duration. Patients stay on treatment as long as they are benefitting. Patients receive androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration. Study doctor will decide what hormone therapy patient will receive.

Drug: Cabozantinib
Starting dose of 60 mg by mouth every day of a 21 day cycle.
Other Names:
  • XL 184
  • Drug: Androgen Ablation Therapy
    Androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration given upon decision of study doctor.

    Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival [31.2 months]

      Progression defined by any of the following: (a) radiographic progression (using RECIST 1.1 for visceral disease and PCWG2 for Bone Scans), (b) receive additional anti-cancer therapy, or (c) clinical progression resulting in stopping the treatment.

    2. Serious Adverse Events and Other (Not Including Serious) Adverse Events [Start of treatment up to 30 days after study drug, up to 80 months]

      Number of instances of Serious Adverse Events and Other (Not Including Serious) Adverse Events. Adverse events were monitored for 30 days beyond the last day of treatment. These adverse events are documented. The adverse events are reported as Serious Adverse Events and Adverse Events. Serious Adverse Events are defined as adverse events in which the participant dies, is hospitalized, is disabled, or is exposed to the medicine while pregnant resulting in and birth defect. Adverse events evaluated for all treated participants using the NCI CTCAE version 4.3.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Histologic proof of prostate adenocarcinoma

    2. Newly diagnosed Androgen-Dependent Prostate Cancer. Patients already on ADT are eligible as long as the time from initiation of LHRH analog or antagonist is not greater than 3 months.

    3. Metastatic disease on bone scan and/or involvement of soft tissues (lymph nodes and/or viscera) by CT scan, PET/CT, or MRI

    4. PSA > 1 ng/ml, unless anaplastic features are present (according to eligibility 10)

    5. Life expectancy from a co-morbid illness > 3 years

    6. Eastern Cooperative Oncology Group (ECOG) performance status </= 2

    7. Patients must have adequate organ function as defined by: Absolute Neutrophil Count (ANC) >/= 1,500/ul (unless due to bone marrow infiltration by tumor in which case ANC

    /=500/ml are allowed) Hemoglobin (Hgb) >/= 9 gm/dL (unless due to bone marrow infiltration by tumor in which case Hgb>8 gm/dL); Total bilirubin </= 1.5times the upper limit of normal (ULN). For patients with known Gilbert's disease, total bilirubin should be </= 3mg/dL; platelet count >/= 100,000/mm^3 (unless due to bone marrow infiltration by tumor in which case >/=50,000/ml are allowed); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) </= 3.0 x ULN if no liver involvement, or </= 5 x ULN with liver involvement; Lipase < 2 x the upper limit of normal; Urine protein/creatinine ratio (UPCR) </= 1; Serum phosphorus >/= lower limits of normal (LLN); estimated creatinine clearance of >/=40 ml/min.

    1. Prior ADT is allowed if it was an adjunct to definite local therapy, was given for </=1 year and was completed at least 12 months before initiating therapy for metastatic disease.

    2. Prior therapy with other tyrosine kinase inhibitors (TKI) inhibitors or any other type of investigational agent is allowed if it was an adjunct to definitive local therapy, was given for </=6 months, and was completed at least 12 months before initiating therapy for metastatic disease.

    3. Patients with "anaplastic" features are eligible for this trial as defined by at least one of the following: a) Any of the following metastatic presentations: exclusive visceral metastases, radiographically predominant lytic bone metastases identified by plain X-ray or CT scan, bulky (>5 cm in longest dimension) lymphadenopathy or high-grade (gleason >8) tumor mass in the prostate/pelvis.; b) Low PSA (</= 10 ng/ml) at initial presentation (prior to androgen ablation or at symptomatic progression in the castrate-setting) plus high volume (>/=20) bone metastases.; c) Elevated serum LDH (>/= 2 x ULN) or elevated serum CEA (>/= 2 x ULN) in the absence of other etiologies.;

    1. Short interval (</= 180 days) to castrate-resistant progression following initiation of hormonal therapy.
    1. Sexually active fertile subjects, and their partners, must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study drug(s).
    Exclusion Criteria:
    1. Biological agents (antibodies, immune modulators, cytokines, or vaccines) or radionuclide treatment within 6 weeks of the first dose of study treatment.

    2. Radiation therapy within 2 weeks prior to initiation of study treatment.

    3. Symptomatic or uncontrolled brain metastasis or epidural disease requiring current treatment including steroids and anti-convulsant.

    4. The subject has had another diagnosis of malignancy requiring systemic treatment within the last two years, unless non-melanoma skin cancer, or superficial bladder cancer.

    5. The subject has uncontrolled or significant intercurrent illness including, but not limited to, the following conditions: Chronically uncontrolled hypertension, defined conventionally as consistent and repeated systolic pressures above 140 mmHg or diastolic pressures above 90 mmHg despite anti-hypertensive therapy. This may be better established with home BP readings than with clinic visit results. There is no criterion related to a specific BP result required for eligibility, nor are acute BP elevations that are related to iatrogenic causes, acute pain, or other transient reversible causes considered to be an exclusion criteria. The intent is to exclude patients with chronically uncontrolled hypertension that might be further exacerbated by Cabozantinib.

    6. Continued from # 5) Other cardiovascular disorders such as symptomatic congestive heart failure (CHF), unstable angina pectoris, clinically-significant cardiac arrhythmias, history of stroke (including transient ischemic attack [TIA], or other ischemic event) within 6 months of study treatment, myocardial infarction within 6 months of study treatment, history of thromboembolic event requiring therapeutic anticoagulation within 6 months of study treatment or main portal vein or vena cava thrombosis or occlusion. ;Gastrointestinal (GI) disorders particularly those associated with a high risk of perforation or fistula formation including: Any of the following at the time of screening; a) intra-abdominal tumor/metastases invading GI mucosa b) active peptic ulcer disease, c) inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis

    7. Continued from # 6) Any of the following within 6 months before the first dose of study treatment: a) history of abdominal fistula b) gastrointestinal perforation c) bowel obstruction or gastric outlet obstruction; d) intra-abdominal abscess. Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more that 6 months ago. GI surgery (particularly when associated with delayed or incomplete healing) within 28 days. Note: Complete healing following abdominal surgery must be confirmed prior to initiating treatment with cabozantinib even if surgery occurred more that 28 days ago. Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy or concurrent evidence of intraluminal tumor involving the trachea and esophagus.

    8. The subject is unable to swallow capsules tablets

    9. The subject has a previously-identified allergy or hypersensitivity to components of the study treatment formulation.

    10. Oral corticosteroids >/= 7.5mg/day prednisone (or prednisone equivalents).

    11. Prior treatment with cabozantinib.

    12. The subject has a corrected QT interval calculated by the Fridericia formula (QTcF)

    500 ms within 28 days before randomization.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • Exelixis
    • High Impact Clinical Research Support Program

    Investigators

    • Principal Investigator: Paul Corn, MD, PHD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01630590
    Other Study ID Numbers:
    • 2012-0252
    • NCI-2014-00934
    First Posted:
    Jun 28, 2012
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by M.D. Anderson Cancer Center
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled from January 2014 - January 2016 at MD Anderson Cancer Center
    Pre-assignment Detail
    Arm/Group Title Cabozantinib + Androgen Ablation Therapy
    Arm/Group Description Patients receive Cabozantinib at starting dose of 60 mg by mouth every day. Study cycles 3 weeks in duration. Patients stay on treatment as long as they are benefitting. Patients receive androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration. Study doctor will decide what hormone therapy patient will receive. Cabozantinib: Starting dose of 60 mg by mouth every day of a 21 day cycle. Androgen Ablation Therapy: Androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration given upon decision of study doctor.
    Period Title: Overall Study
    STARTED 62
    COMPLETED 5
    NOT COMPLETED 57

    Baseline Characteristics

    Arm/Group Title Cabozantinib + Androgen Ablation Therapy
    Arm/Group Description Patients receive Cabozantinib at starting dose of 60 mg by mouth every day. Study cycles 3 weeks in duration. Patients stay on treatment as long as they are benefitting. Patients receive androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration. Study doctor will decide what hormone therapy patient will receive. Cabozantinib: Starting dose of 60 mg by mouth every day of a 21 day cycle. Androgen Ablation Therapy: Androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration given upon decision of study doctor.
    Overall Participants 62
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    62
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    Male
    62
    100%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    5
    8.1%
    Not Hispanic or Latino
    56
    90.3%
    Unknown or Not Reported
    1
    1.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    1
    1.6%
    White
    57
    91.9%
    More than one race
    0
    0%
    Unknown or Not Reported
    4
    6.5%
    Region of Enrollment (participants) [Number]
    United States
    62
    100%
    Eastern Cooperative Oncology Group (ECOG) Performance Status (Count of Participants)
    Grade 0
    45
    72.6%
    Grade 1
    17
    27.4%
    Grade 2
    0
    0%
    Prior Treatment of Primary Tumor (Count of Participants)
    No Prior Treatment
    46
    74.2%
    Yes Prior Treatment
    16
    25.8%
    Gleason Score (Count of Participants)
    Gleason 6-7
    10
    16.1%
    Gleason 7 + 5
    2
    3.2%
    Gleason 8-10
    45
    72.6%
    Unknown Gleason Score
    5
    8.1%
    Prostate Specific Antigen (PSA) Levels (ng/mL) [Median (Full Range) ]
    Median (Full Range) [ng/mL]
    64.7
    Bone Specific Alkaline Phosphatase Level (µg/L) [Median (Full Range) ]
    Median (Full Range) [µg/L]
    61
    Bone Metastases (Count of Participants)
    Bone Metastases
    58
    93.5%
    Bone Only
    27
    43.5%
    Visceral Metastases (Count of Participants)
    Count of Participants [Participants]
    8
    12.9%
    Soft-Tissue Metastases (Count of Participants)
    None
    29
    46.8%
    Lymph Nodes
    33
    53.2%
    Liver
    2
    3.2%
    Lung
    6
    9.7%
    Volume of Metastases (Count of Participants)
    Low
    8
    12.9%
    High
    54
    87.1%

    Outcome Measures

    1. Primary Outcome
    Title Progression Free Survival
    Description Progression defined by any of the following: (a) radiographic progression (using RECIST 1.1 for visceral disease and PCWG2 for Bone Scans), (b) receive additional anti-cancer therapy, or (c) clinical progression resulting in stopping the treatment.
    Time Frame 31.2 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Cabozantinib + Androgen Ablation Therapy
    Arm/Group Description Patients receive Cabozantinib at starting dose of 60 mg by mouth every day. Study cycles 3 weeks in duration. Patients stay on treatment as long as they are benefitting. Patients receive androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration. Study doctor will decide what hormone therapy patient will receive. Cabozantinib: Starting dose of 60 mg by mouth every day of a 21 day cycle. Androgen Ablation Therapy: Androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration given upon decision of study doctor.
    Measure Participants 62
    Median (95% Confidence Interval) [months]
    16.1
    2. Primary Outcome
    Title Serious Adverse Events and Other (Not Including Serious) Adverse Events
    Description Number of instances of Serious Adverse Events and Other (Not Including Serious) Adverse Events. Adverse events were monitored for 30 days beyond the last day of treatment. These adverse events are documented. The adverse events are reported as Serious Adverse Events and Adverse Events. Serious Adverse Events are defined as adverse events in which the participant dies, is hospitalized, is disabled, or is exposed to the medicine while pregnant resulting in and birth defect. Adverse events evaluated for all treated participants using the NCI CTCAE version 4.3.
    Time Frame Start of treatment up to 30 days after study drug, up to 80 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Cabozantinib + Androgen Ablation Therapy
    Arm/Group Description Patients receive Cabozantinib at starting dose of 60 mg by mouth every day. Study cycles 3 weeks in duration. Patients stay on treatment as long as they are benefitting. Patients receive androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration. Study doctor will decide what hormone therapy patient will receive. Cabozantinib: Starting dose of 60 mg by mouth every day of a 21 day cycle. Androgen Ablation Therapy: Androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration given upon decision of study doctor.
    Measure Participants 62
    Other (Not Including Serious) Adverse Events
    2105
    Serious Adverse Events
    3

    Adverse Events

    Time Frame From the first dose through 30 days after the last day of treatment, up to 80 months
    Adverse Event Reporting Description
    Arm/Group Title Cabozantinib + Androgen Ablation Therapy
    Arm/Group Description Patients receive Cabozantinib at starting dose of 60 mg by mouth every day. Study cycles 3 weeks in duration. Patients stay on treatment as long as they are benefitting. Patients receive androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration. Study doctor will decide what hormone therapy patient will receive. Cabozantinib: Starting dose of 60 mg by mouth every day of a 21 day cycle. Androgen Ablation Therapy: Androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration given upon decision of study doctor.
    All Cause Mortality
    Cabozantinib + Androgen Ablation Therapy
    Affected / at Risk (%) # Events
    Total 24/62 (38.7%)
    Serious Adverse Events
    Cabozantinib + Androgen Ablation Therapy
    Affected / at Risk (%) # Events
    Total 3/62 (4.8%)
    Gastrointestinal disorders
    Diarrhea 1/62 (1.6%)
    Renal and urinary disorders
    Proteinuria 1/62 (1.6%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 1/62 (1.6%)
    Other (Not Including Serious) Adverse Events
    Cabozantinib + Androgen Ablation Therapy
    Affected / at Risk (%) # Events
    Total 62/62 (100%)
    Blood and lymphatic system disorders
    Anemia 41/62 (66.1%) 56
    Endocrine disorders
    Hyperthyroidism 6/62 (9.7%) 7
    Hypothyroidism 41/62 (66.1%) 57
    Gastrointestinal disorders
    Abdominal Pain 6/62 (9.7%) 8
    Bloating 3/62 (4.8%) 4
    Constipation 22/62 (35.5%) 36
    Diarrhea 46/62 (74.2%) 142
    Dry Mouth 8/62 (12.9%) 8
    Dyspepsia 7/62 (11.3%) 9
    Flatulence 5/62 (8.1%) 5
    Gastroesophageal Reflux Disease 18/62 (29%) 25
    Mucositis Oral 18/62 (29%) 37
    Nausea 21/62 (33.9%) 57
    Oral Dysesthesia 28/62 (45.2%) 43
    Oral Pain 11/62 (17.7%) 12
    Stomach Pain 3/62 (4.8%) 7
    Vomiting 14/62 (22.6%) 21
    General disorders
    Edema 54/62 (87.1%) 120
    Fatigue 54/62 (87.1%) 120
    Non-cardiac Chest Pain 4/62 (6.5%) 4
    Pain 32/62 (51.6%) 58
    Hepatobiliary disorders
    Lactate Dehydrogenase Increase 31/62 (50%) 58
    Investigations
    Alanine Aminotransferase Increase 50/62 (80.6%) 116
    Alkaline Phosphatase Increase 17/62 (27.4%) 30
    Aspartate Aminotransferase Increase 52/62 (83.9%) 148
    Bilirubin Increase 11/62 (17.7%) 16
    Lipase Increase 15/62 (24.2%) 21
    Neutrophil Count Decrease 21/62 (33.9%) 45
    Platelet Count Decrease 23/62 (37.1%) 29
    Amylase Increase 3/62 (4.8%) 3
    Weight Loss 8/62 (12.9%) 12
    White Blood Cell Decrease 29/62 (46.8%) 61
    Metabolism and nutrition disorders
    Anorexia 18/62 (29%) 26
    Dehydration 3/62 (4.8%) 3
    Hypercalcemia 4/62 (6.5%) 4
    Hyperglycemia 8/62 (12.9%) 16
    Hypernatremia 4/62 (6.5%) 4
    Hyperkalemia 8/62 (12.9%) 8
    Hypoalbuminemia 18/62 (29%) 36
    Hypocalcemia 8/62 (12.9%) 12
    Hypoglycemia 3/62 (4.8%) 3
    Hypokalemia 8/62 (12.9%) 10
    Hypomagnesemia 31/62 (50%) 67
    Hyponatremia 5/62 (8.1%) 8
    Musculoskeletal and connective tissue disorders
    Cramping in Extremities 7/62 (11.3%) 13
    Myalgia 3/62 (4.8%) 3
    Nervous system disorders
    Dizziness 10/62 (16.1%) 11
    Dysgeusia 37/62 (59.7%) 49
    Headache 7/62 (11.3%) 8
    Memory Impairment 3/62 (4.8%) 3
    Paresthesia 17/62 (27.4%) 22
    Neuropathy 4/62 (6.5%) 7
    Renal and urinary disorders
    Hematuria 4/62 (6.5%) 4
    Proteinuria 39/62 (62.9%) 79
    Respiratory, thoracic and mediastinal disorders
    Cough 8/62 (12.9%) 8
    Dyspnea 19/62 (30.6%) 26
    Hoarseness 21/62 (33.9%) 25
    Sore Throat 11/62 (17.7%) 13
    Upper Respiratory Infection 4/62 (6.5%) 4
    Voice Alteration 5/62 (8.1%) 5
    Skin and subcutaneous tissue disorders
    Alopecia 15/62 (24.2%) 17
    Dry Skin 20/62 (32.3%) 21
    Palmer Plantar Erythrodysesthesia 33/62 (53.2%) 82
    Rash 33/62 (53.2%) 82
    Skin Hypopigmentation 6/62 (9.7%) 7
    Vascular disorders
    Flushing 3/62 (4.8%) 3
    Hypertension 25/62 (40.3%) 37
    Thromboembolic Event 3/62 (4.8%) 4

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE 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 Dr. Paul Corn, Chair Ad Interim, Genitourinary Medical Oncology
    Organization UT MD Anderson Cancer Center
    Phone (713) 563-7208
    Email pcorn@mdanderson.org
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01630590
    Other Study ID Numbers:
    • 2012-0252
    • NCI-2014-00934
    First Posted:
    Jun 28, 2012
    Last Update Posted:
    Mar 25, 2022
    Last Verified:
    Mar 1, 2022