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Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer
This study has been completed.
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Matthew R. Smith, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01347788
First received: April 11, 2011
Last updated: October 17, 2016
Last verified: October 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Prostate Adenocarcinoma | Drug: cabozantinib | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Dose-Finding Pilot Study of XL184 in Men With Castrate-Resistant Prostate Cancer and Bone Metastases |
Resource links provided by NLM:
Genetics Home Reference related topics:
prostate cancer
MedlinePlus related topics:
Prostate Cancer
Drug Information available for:
Cabozantinib
U.S. FDA Resources
Further study details as provided by Matthew R. Smith, MD, PhD, Massachusetts General Hospital:
Primary Outcome Measures:
- 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.
| Enrollment: | 34 |
| Study Start Date: | April 2011 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
Dose level 0: cabozantinib 40 mg daily
|
Drug: cabozantinib
Cabozantinib PO QD
Other Name: XL84
|
|
Experimental: Cohort 2
Dose level -1: cabozantinib 20 mg daily
|
Drug: cabozantinib
Cabozantinib PO QD
Other Name: XL84
|
|
Experimental: Expansion cohort
Dose level 0: cabozantinib 40 mg daily
|
Drug: cabozantinib
Cabozantinib PO QD
Other Name: XL84
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347788
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347788
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Matthew R Smith, M.D., Ph.D. | Massachusetts General Hospital |
More Information
Publications:
| Responsible Party: | Matthew R. Smith, MD, PhD, Professor of Medicine, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01347788 History of Changes |
| Other Study ID Numbers: |
11-005 |
| Study First Received: | April 11, 2011 |
| Results First Received: | September 15, 2014 |
| Last Updated: | October 17, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Matthew R. Smith, MD, PhD, Massachusetts General Hospital:
|
Prostate cancer Castration Resistant Bone Metastases |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Adenocarcinoma Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Prostatic Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on August 21, 2017