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

Primary Purpose

Prostate Adenocarcinoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

cabozantinib

About this trial

This is an interventional treatment trial for Prostate Adenocarcinoma focused on measuring Prostate cancer, Castration Resistant, Bone Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Expansion cohort

Arm Description

Dose level 0: cabozantinib 40 mg daily

Dose level -1: cabozantinib 20 mg daily

Dose level 0: cabozantinib 40 mg daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01347788

First Posted

April 11, 2011

Last Updated

October 17, 2016

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01347788

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Adenocarcinoma

Keywords

Prostate cancer, Castration Resistant, Bone Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

Dose level 0: cabozantinib 40 mg daily

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

Dose level -1: cabozantinib 20 mg daily

Arm Title

Expansion cohort

Arm Type

Experimental

Arm Description

Dose level 0: cabozantinib 40 mg daily

Intervention Type

Drug

Intervention Name(s)

cabozantinib

Other Intervention Name(s)

XL84

Intervention Description

Cabozantinib PO QD

Primary Outcome Measure Information:

Title

Partial Response in Bone Scan From Baseline to Week 6

Description

Time Frame

Baseline and Week 6

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew R Smith, M.D., Ph.D.

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

23553848

Citation

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.

Results Reference

result

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

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