Cabozantinib in Advanced Solid Malignancies

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Rebecca Suk Heist, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01588821
First received: April 26, 2012
Last updated: December 20, 2013
Last verified: December 2013

April 26, 2012
December 20, 2013
June 2012
June 2014   (final data collection date for primary outcome measure)
Effect of Cabozantinib on Bone Biomarkers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Effect of cabozantinib on bone biomarkers of osteoblast and osteoclast acitivity (urinary NTx, serum NTx, serum CTx, among others)
Same as current
Complete list of historical versions of study NCT01588821 on ClinicalTrials.gov Archive Site
  • Rate of skeletal-related event (SRE) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Rate of SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia)
  • Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Quality of life as measured by pain and analgesic scores and the Functional Assessment of Cancer Therapy - General (FACT-G)
  • Overall Tumor Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Overall tumor response rate by Response Evaluation Criteria in Solid Tumors (RECIST) if patient has RECIST evaluable disase
  • MET amplification in tumor sample [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Response will be correlated with specific tumor genotype (MET amplification).
  • Response to Cabozantinib in Bone Metastatic Disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Response to cabozantinib in bone metastatic disease as measured by bone scan or PET-CT scan
  • Time to SRE [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time to SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia)
  • Rate of skeletal-related event (SRE) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Rate of SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia)
  • Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Quality of life as measured by pain and analgesic scores and the Functional Assessment of Cancer Therapy - General (FACT-G)
  • Overall Tumor Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Overall tumor response rate by Response Evaluation Criteria in Solid Tumors (RECIST) if patient has RECIST evaluable disase
  • Correlate Response with Tumor Genotyping [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Correlate response with specific tumor genotype (e.g. MET amplification).
  • Response to Cabozantinib in Bone Metastatic Disease [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Response to cabozantinib in bone metastatic disease as measured by bone scan or PET-CT scan
  • Time to SRE [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time to SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia)
Not Provided
Not Provided
 
Cabozantinib in Advanced Solid Malignancies
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.

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lung Cancer
  • Solid Tumor (Not Breast or Prostate Cancers)
Drug: Cabozantinib
60 mg daily by mouth
Other Name: XL184
Experimental: Treatment Arm
Cabozantinib
Intervention: Drug: Cabozantinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
29
Not Provided
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Rebecca Heist, MD 617-726-8033 rheist@partners.org
United States
 
NCT01588821
12-091
Yes
Rebecca Suk Heist, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Rebecca Heist, MD MGH
Massachusetts General Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP