Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments cabozantinib, androgen ablation therapy
Phase phase 2
Targets c-MET, VEGF, RET, AXL, FLT-3, KIT, TRKB, TIE2
Sponsor M.D. Anderson Cancer Center
Collaborator Exelixis
Start date January 2014
End date January 2018
Trial size 60 participants
Trial identifier NCT01630590, 2012-0252, NCI-2014-00934

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 XL 184
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.

Primary Outcomes

Measure
Progression Free Survival
time frame: 12 weeks

Eligibility Criteria

Male participants of any age.

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 /= 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 /= 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) /= lower limits of normal (LLN); estimated creatinine clearance of >/=40 ml/min. 8. Prior ADT is allowed if it was an adjunct to definite local therapy, was given for 5 cm in longest dimension) lymphadenopathy or high-grade (gleason >8) tumor mass in the prostate/pelvis.; b) Low PSA (/=20) bone metastases.; c) Elevated serum LDH (>/= 2 x ULN) or elevated serum CEA (>/= 2 x ULN) in the absence of other etiologies.; d) Short interval (/= 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.

Additional Information

Official title An Observational Study of XL-184 Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer
Principal investigator Paul Corn, MD, PHD
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. 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.
Location data was received from the National Cancer Institute and was last updated in June 2016.