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

Prostate Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347788
• Other study ID #: 11-005
• Status: Completed
• Phase: Phase 1
• First received: April 11, 2011
• Last updated: October 16, 2015
• Start date: April 2011
• Est. completion date: May 2013

Study information

• Verified date: October 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms

Intervention

Drug:
• cabozantinib
Cabozantinib PO QD

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & 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 Re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No