Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer
Dose-Finding Pilot Study of XL184 in Men With Castrate-Resistant Prostate Cancer and Bone Metastases
1 other identifier
interventional
34
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2011
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 11, 2011
CompletedFirst Posted
Study publicly available on registry
May 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
November 17, 2015
CompletedNovember 28, 2016
October 1, 2016
2.1 years
April 11, 2011
September 15, 2014
October 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Partial Response in Bone Scan From Baseline to 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
Study Arms (3)
Cohort 1
EXPERIMENTALDose level 0: cabozantinib 40 mg daily
Cohort 2
EXPERIMENTALDose level -1: cabozantinib 20 mg daily
Expansion cohort
EXPERIMENTALDose level 0: cabozantinib 40 mg daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Lee RJ, Saylor PJ, Michaelson MD, Rothenberg SM, Smas ME, Miyamoto DT, Gurski CA, Xie W, Maheswaran S, Haber DA, Goldin JG, Smith MR. A dose-ranging study of cabozantinib in men with castration-resistant prostate cancer and bone metastases. Clin Cancer Res. 2013 Jun 1;19(11):3088-94. doi: 10.1158/1078-0432.CCR-13-0319. Epub 2013 Apr 3.
PMID: 23553848RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Lee RJ, Saylor PJ, Michaelson MD, Rothenberg SM, Smas ME, Miyamoto DT, Gurski CA, Xie W, Maheswaran S, Haber DA, Goldin JG, Smith MR. Clin Cancer Res. 2013 Jun 1;19(11):3088-94. doi: 10.1158/1078-0432.CCR-13-0319. Epub 2013 Apr 3.
Results Point of Contact
- Title
- Matthew R Smith, MDPhD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew R Smith, M.D., Ph.D.
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
April 11, 2011
First Posted
May 4, 2011
Study Start
April 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
November 28, 2016
Results First Posted
November 17, 2015
Record last verified: 2016-10