Cabozantinib in Advanced Solid Malignancies

This study is currently recruiting participants.
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
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Solid Tumor (Not Breast or Prostate Cancers)
Drug: Cabozantinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Cabozantinib (XL184) in Patients With Advanced Solid (Non-breast, Non-prostate) Malignancies and Bony Metastases

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 29
Study Start Date: June 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Cabozantinib
Drug: Cabozantinib
60 mg daily by mouth
Other Name: XL184

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588821

Contacts
Contact: Rebecca Heist, MD 617-726-8033 rheist@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rebecca Heist, MD         
Principal Investigator: Rebecca Heist, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Rebecca Heist, MD MGH
  More Information

No publications provided

Responsible Party: Rebecca Suk Heist, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01588821     History of Changes
Other Study ID Numbers: 12-091
Study First Received: April 26, 2012
Last Updated: December 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Metastatic
Refractory
Relapsed

Additional relevant MeSH terms:
Lung Neoplasms
Prostatic Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 23, 2014