NCT01574937

Brief Summary

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. It also means that the FDA (U.S. Food and Drug Administration) may not have approved this drug for use in participants, including people with your type of cancer. In this research study, we are testing the safety of XL184 at different dose levels. XL184 is a new study drug, which is taken by mouth. Laboratory studies have shown that XL184 may prevent tumor growth by stopping the formation of blood vessels inside the tumor and also shrink tumors. This drug has been used in early-stage studies and is also currently being studied in other trials. Information from those other research studies suggests that XL184 may help to slow or stop tumor growth including prostate cancer. We will also be taking blood and urine tests to look at how your body processes the drug.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Timeline
Completed

Started Apr 2012

Longer than P75 for phase_1 prostate-cancer

Geographic Reach
1 country

2 active sites

Status
completed

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 3, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

2.7 years

First QC Date

April 8, 2012

Last Update Submit

August 5, 2021

Conditions

Prostate Cancer

Keywords

Castration ResistantPost Chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose

    To define the MTD of cabozantinib in combination with abiraterone

    2 years

Secondary Outcomes (1)

  • Definition of a Dosing Regimen

    2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Cabozantinib and abiraterone

Drug: CabozantinibDrug: Abiraterone

Interventions

CabozantinibDRUG

28 day cycle

Also known as: XL 184
Treatment Arm
AbirateroneDRUG

28 day cycle

Also known as: Zytiga
Treatment Arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CRPC with up to 2 prior chemotherapy regimens
  • Progressive disease on CT, MRI or bone scan per mRECIST
  • Has recovered to baseline/CTCAE less than or equal to Grade 1 from toxicities related to prior treatment (except alopecia)
  • Agree to use accepted barrier method of contraception

You may not qualify if:

  • Cytotoxic chemotherapy within 3 weeks
  • Prior treatment with cabozantinib or other c-MET inhibitor
  • Prior therapy with a lyase inhibitor
  • Concurrent use of hormonal therapies other than LHRH analogue or orchiectomy
  • Received radiation therapy to thoracic cavity or GI tract within 3 months, to bone or brain metastasis within 2 weeks or to any other site within 4 weeks of first dose of study drug
  • Prior treatment with a small molecular kinase inhibitor within 2 weeks of study entry
  • Received another investigational product within 28 days prior to study entry
  • Active brain metastases or epidural disease
  • Requires concomitant treatment in therapeutic doses with warfarin or warfarin-related agents
  • No uncontrolled significant intercurrent or recent illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabozantinibabirateroneAbiraterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Christopher Sweeney, MBBS

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 8, 2012

First Posted

April 10, 2012

Study Start

April 3, 2012

Primary Completion

December 31, 2014

Study Completion

July 1, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)