Cabozantinib in Advanced Solid Malignancies
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lung Cancer, Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/14/2018 |
| Start Date: | June 2012 |
| End Date: | June 2019 |
Phase II Trial of Cabozantinib (XL184) in Patients With Advanced Solid (Non-breast, Non-prostate) Malignancies and Bony Metastases
This research study is a Phase II clinical trial. Phase II clinical trials test the
effectiveness of an investigational drug to learn whether the drug works in treating a
specific cancer. "Investigational" means that the drug is still being studied and that
research doctors are trying to find out more about it-such as the safest dose to use, the
side effects it may cause, and if the drug is effective for treating different types of
cancer. It also means that the FDA has not approved the drug for this type of cancer, or for
any use outside of research studies.
When cancer spreads from the primary tumor, one of the most commons sites it spreads to is
bone. When cancer spreads to bone there can be significant symptoms such as pain.
Cabozantinib works by blocking signaling that leads to cancer growth as well as blocking the
growth of new blood vessels (angiogenesis) that help to feed a tumor. Cabozantinib has been
studied or is being studied in research studies as a possible treatment for various types of
cancer, including prostate cancer, brain cancer, thyroid cancer, lung cancer and kidney
cancer.
Previous clinical research studies indicate that cabozantinib may also have activity against
cancer once it has spread to the bones.
The purpose of this study is to find out if cabozantinib is effective in treating cancer that
has spread to the bone.
effectiveness of an investigational drug to learn whether the drug works in treating a
specific cancer. "Investigational" means that the drug is still being studied and that
research doctors are trying to find out more about it-such as the safest dose to use, the
side effects it may cause, and if the drug is effective for treating different types of
cancer. It also means that the FDA has not approved the drug for this type of cancer, or for
any use outside of research studies.
When cancer spreads from the primary tumor, one of the most commons sites it spreads to is
bone. When cancer spreads to bone there can be significant symptoms such as pain.
Cabozantinib works by blocking signaling that leads to cancer growth as well as blocking the
growth of new blood vessels (angiogenesis) that help to feed a tumor. Cabozantinib has been
studied or is being studied in research studies as a possible treatment for various types of
cancer, including prostate cancer, brain cancer, thyroid cancer, lung cancer and kidney
cancer.
Previous clinical research studies indicate that cabozantinib may also have activity against
cancer once it has spread to the bones.
The purpose of this study is to find out if cabozantinib is effective in treating cancer that
has spread to the bone.
Cabozantinib is a tablet that the subject will take by mouth. The subject will take it once
per day. The study treatment with cabozantinib will be divided into 28 day cycles. A member
of the study staff will give the subject a drug diary and explain to the subject how to use
it to record doses of cabozantinib. This diary will also contain specific instructions about
how the subject take cabozantinib.
Every 28 days the subject will undergo the following procedures: Physical examination,
questions about any side effects the subject may have, blood samples for routine laboratory
tests and research tests, urine sample, electrocardiogram (EKG), and questionnaires to
measure quality of life and level of pain. Every two months the subject will undergo a CT
scan or MRI to evaluate the subjects disease.
The investigators would like the subject to return to the study clinic for follow-up
procedures about 4-5 weeks after the last dose of cabozantinib.
The subject can continue to receive the study drug for as long as their disease does not
worsen and the subject do not experience unacceptable side effects.
per day. The study treatment with cabozantinib will be divided into 28 day cycles. A member
of the study staff will give the subject a drug diary and explain to the subject how to use
it to record doses of cabozantinib. This diary will also contain specific instructions about
how the subject take cabozantinib.
Every 28 days the subject will undergo the following procedures: Physical examination,
questions about any side effects the subject may have, blood samples for routine laboratory
tests and research tests, urine sample, electrocardiogram (EKG), and questionnaires to
measure quality of life and level of pain. Every two months the subject will undergo a CT
scan or MRI to evaluate the subjects disease.
The investigators would like the subject to return to the study clinic for follow-up
procedures about 4-5 weeks after the last dose of cabozantinib.
The subject can continue to receive the study drug for as long as their disease does not
worsen and the subject do not experience unacceptable side effects.
Inclusion Criteria:
- Histologic or cytologic diagnosis of a solid tumor (not breast or prostate) that is
metastatic and refractory to or progressed following standard therapies
- Has bony metastases
- Agree to use medically accepted methods of contraception
Exclusion Criteria:
- Pregnant or breastfeeding
- Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or
biologic agents within 3 weeks of study entry(6 weeks for nitrosoureas/mitomycin C)
- Received radiation to the thoracic cavity/GI tract (within 3 months of study entry),
to bone or brain metastasis (within 14 days) or to any other site within 28 days
- Received prior treatment with small molecule kinase inhibitor or hormonal therapy
within 14 days/5 half-lives
- Received therapy with another investigational agent within past 28 days
- Has not recovered from toxicities due to prior therapies
- Primary brain tumor
- Active brain metastases or epidural disease
- Uncontrolled significant intercurrent or recent illness
- Allergy or hypersensitivity to components of the study treatment formulation
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Rebecca Heist, MD
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