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An Observational Study of XL-184 Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer

Phase 2
Not Enrolling
Prostate Cancer

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Trial Information

An Observational Study of XL-184 Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer

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.

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 6 weeks, this blood
will also be used to measure your PSA.

- Urine will be collected for routine tests (every 6 weeks).

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

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.

Inclusion Criteria:

1. Histologic proof of prostate adenocarcinoma

2. Androgen-Dependent Prostate Cancer

3. Metastatic disease on bone scan and/or involvement of soft tissues (lymph nodes
and/or viscera) by computed tomography (CT) scan and/or magnetic resonance imaging

4. PSA > 1 ng/ml

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

6. Eastern Cooperative Oncology Group (ECOG) performance status
7. Patients must have adequate organ function as defined by: Absolute Neutrophil Count
(ANC) >/= 1,500/ul (without colony stimulating factor support); Hemoglobin (Hgb) >/=
9 gm/dL; Total bilirubin with known Gilbert's disease, total bilirubin should be >/= 100,000/mm^3; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
< 1.5 x the upper limit of normal; Urine protein/creatinine ratio (UPCR) phosphorus >/= lower limits of normal (LLN); estimated creatinine clearance of >/=40

8. Patients already on Androgen Deprivation Therapy (ADT) are eligible as long as the
time from initiation of luteinizing hormone-releasing hormone (LHRH) analog or
antagonist is not greater than 1 month.

9. Prior ADT is allowed if it was an adjunct to definite local therapy, was given for
metastatic diseases

10. 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 initiating therapy for metastatic disease.

11. Patients with "anaplastic" features are eligible for this trial.

12. 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

5. The subject has prothrombin time (PT)/ International Normalized Ratio (INR) or
partial thromboplastin time (PTT) test results at screening >/= 1.3 x the laboratory

6. The subject requires concomitant treatment, in therapeutic doses, with anticoagulants
such as warfarin or Coumadin-related agents, heparin, thrombin or Factor Xa (FXa)
inhibitors, and antiplatelet agents (eg, clopidogrel). Low dose aspirin ( mg/day), low-dose warfarin ( Heparin (LMWH) are permitted.

7. The subject has uncontrolled or significant intercurrent illness including, but not
limited to, the following conditions: Cardiovascular disorders such as symptomatic
congestive heart failure (CHF), uncontrolled hypertension defined as sustained blood
pressure (BP) > 140 mm mercury (Hg) systolic, or > 90 mm Hg diastolic despite optimal
antihypertensive treatment (BP must be controlled at screening), 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;

8. Continued from # 9) 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;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

9. Continued from # 10) ;Other disorders associated with a high risk of fistula
formation including percutaneous endoscopic gastrostomy (PEG) tube placement within 3
months before the first dose of study therapy or concurrent evidence of intraluminal
tumor involving the trachea and esophagus.

10. The subject is unable to swallow capsules tablets

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

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

13. Prior treatment with cabozantinib.

14. The subject has a corrected QT interval calculated by the Fridericia formula (QTcF)
>500 ms within 28 days before randomization.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

Castrate-resistant progression defined by any of the following: (a) radiographic progression (using RECIST 1.1 for visceral disease and PCWG2 for Bone Scans), (b) receipt of additional anti-cancer therapy, or (c) clinical progression warranting discontinuation from the study as judged by the treating physician.

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Paul Corn, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2013

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Metastatic Prostate Cancer
  • Prostate adenocarcinoma
  • Androgen-Dependent Prostate Cancer
  • Cabozantinib
  • XL 184
  • Androgen Ablation
  • Prostatic Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030