Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer

October 17, 2016 updated by: Matthew R. Smith, MD, PhD, Massachusetts General Hospital

Dose-Finding Pilot Study of XL184 in Men With Castrate-Resistant Prostate Cancer and Bone Metastases

Cabozantinib (XL184) is a new drug that is being developed to treat cancer. Cabozantinib works by blocking the "angiogenesis," or the growth of new blood vessels, to the tumor. This is similar to how several other cancer drugs work but in addition Cabozantinib also blocks other pathways that may be responsible for allowing cancer cells to become resistant to these other "anti-angiogenic" treatments. So far cabozantinib has been investigated in treating brain cancer and a rare form of thyroid cancer. This study will explore lower doses of cabozantinib with the goal to find the most effective, safe, and tolerable dose without undesirable side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cabozantinib will be taken by mouth daily. The first five treatment cycles will be 21 days. All cycles after that will be 42 days long. Patients will keep a diary to record study drug dosing.

During the screening phase patients will receive a physical exam, blood and urine tests, a bone scan, a CT of the abdomen and pelvis, and an MRI scan of total body. On Day 1 of each cycle patients will receive a physical exam and blood and urine tests. Bone scan, CT and MRI scans will be performed at the start of cycles 3 and 5, and then repeated once every 12 weeks.

Patients will continue to receive study treatment as long as they are receiving benefit from the treatment, do not experience any severe or unmanageable side effects, and disease does not get any worse.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Histologically confirmed prostate adenocarcinoma
  • Bone metastases confirmed by bone scan
  • Current androgen deprivation therapy
  • Castration-resistant disease based on progression in bone and/or PSA progression
  • Recovered from toxicities related to prior treatment, except alopecia, lymphopenia, other non-clinically significant adverse events
  • Life expectancy of greater than 3 months
  • Normal organ and marrow function
  • Capable of understanding and complying with the protocol requirements
  • Agree to use medically accepted methods of contraception
  • Able to swallow capsules

Exclusion Criteria:

  • More than two prior chemotherapy regimens for metastatic prostate cancer
  • Known untreated, symptomatic or uncontrolled brain metastases
  • Serious or unhealed wound
  • Treatment with anticoagulants
  • Previously identified allergy or hypersensitivity to components of the study treatment formulation
  • History of a different malignancy unless disease-free for at least 5 years, or basal or squamous cell carcinoma of the skin
  • Current antiretroviral therapy
  • Uncontrolled hypertension
  • Uncontrolled intercurrent illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Dose level 0: cabozantinib 40 mg daily
Drug: cabozantinib
Cabozantinib PO QD
Other Names:
  • XL84
Experimental: Cohort 2
Dose level -1: cabozantinib 20 mg daily
Drug: cabozantinib
Cabozantinib PO QD
Other Names:
  • XL84
Experimental: Expansion cohort
Dose level 0: cabozantinib 40 mg daily
Drug: cabozantinib
Cabozantinib PO QD
Other Names:
  • XL84

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partial Response in Bone Scan From Baseline to Week 6
Time Frame: Baseline and Week 6
Bone scans will be centrally reviewed and categorized based on comparison of week 6 and baseline imaging. Partial response is defined as 30% or greater decrease in bone scan lesion area from baseline to week 6. An adaptive response design to determine the lowest effective cabozantinib dose among three dose levels (dose level +1, dose level 0 and dose level +1) will be employed.
Baseline and Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Matthew R Smith, M.D., Ph.D., Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

April 11, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (Estimate)

May 4, 2011

Study Record Updates

Last Update Posted (Estimate)

November 28, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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