Phase II Trial of Cabozantinib (XL184) in Patients With Advanced Solid (Non-breast, Non-prostate) Malignancies and Bony Metastases
18 Years
N/A
Both
Lung Cancer, Solid Tumor (Not Breast or Prostate Cancers)
Trial Information
Phase II Trial of Cabozantinib (XL184) in Patients With Advanced Solid (Non-breast, Non-prostate) Malignancies and Bony Metastases
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Effect of Cabozantinib on Bone Biomarkers
Outcome Description:
Effect of cabozantinib on bone biomarkers of osteoblast and osteoclast acitivity (urinary NTx, serum NTx, serum CTx, among others)
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Rebecca Heist, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
MGH
Authority:
United States: Food and Drug Administration
Study ID:
12-091
NCT ID:
NCT01588821
Start Date:
June 2012
Completion Date:
Related Keywords:
- Lung Cancer
- Solid Tumor (Not Breast or Prostate Cancers)
- Metastatic
- Refractory
- Relapsed
- Lung Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
