XL-184+Abiraterone in Post-Chemo CRPC
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2019 |
| Start Date: | September 2012 |
| End Date: | December 2019 |
A Dose Finding Clinical Trial of Cabozantinib (XL 184) Administered in Combination With Abiraterone in Castration Resistant Prostate Cancer
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.
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.
The following procedures will be performed during this study. On Day 1 for every cycle (28
days/4 weeks)-The following will be undertaken prior to initiating study therapy and on day 1
of every subsequent cycle: A medical history, physical exam, performance status, blood tests,
urine test.
Since we are looking for the highest dose of the study drug that can be administered safely
without severe or unmanageable side effects in participants, not everyone who participates in
this research study will receive the same dose of the study drug. The dose you get will
depend on the number of participants who have been enrolled in the study before you and how
well they have tolerated their doses.
We will actively monitor your condition for up to 30 days after you come off the study. If
you come off study for a side effect we will monitor your condition until the resolution or
stabilization of the side effect
days/4 weeks)-The following will be undertaken prior to initiating study therapy and on day 1
of every subsequent cycle: A medical history, physical exam, performance status, blood tests,
urine test.
Since we are looking for the highest dose of the study drug that can be administered safely
without severe or unmanageable side effects in participants, not everyone who participates in
this research study will receive the same dose of the study drug. The dose you get will
depend on the number of participants who have been enrolled in the study before you and how
well they have tolerated their doses.
We will actively monitor your condition for up to 30 days after you come off the study. If
you come off study for a side effect we will monitor your condition until the resolution or
stabilization of the side effect
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
3
sites
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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