Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Cabozantinib in Advanced Solid Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01588821
Recruitment Status : Completed
First Posted : May 1, 2012
Results First Posted : January 10, 2018
Last Update Posted : September 29, 2020
Information provided by (Responsible Party):
Rebecca Suk Heist, MD, Massachusetts General Hospital

Brief Summary:

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2012
Actual Primary Completion Date : January 2017
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment Arm
Drug: Cabozantinib
60 mg daily by mouth
Other Name: XL184

Primary Outcome Measures :
  1. Number of Participants With Bone Bio-marker Response [ Time Frame: 8 Weeks ]
    Effect of cabozantinib on bone biomarkers of osteoblast and osteoclast activity. The bio-markers of interest were serum C-terminal telopeptide (Ctx), urine N-terminal telopeptide (Ntx), serum (Ntx). Participants were considered to have a response if there was at least a 40% decrease in the bio-marker concentration.

Secondary Outcome Measures :
  1. Number of Patients With Skeletal-related Events (SRE) [ Time Frame: 2 years ]
    The number of patients that experience a SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia)

  2. Quality of Life as Assessed by FACT-G [ Time Frame: From baseline to Cycle 3 Day 1 (approximately 2 months) ]
    Quality of life as measured by the Functional Assessment of Cancer Therapy - General (FACT-G). FACT-G assesses patients' physical, social/family, emotional, and functional well-being. The total score can range from 0 to 108, with lower scores indicating higher quality of life. Patients without QOL scores at cycle 3 day 1 had their score from their last assessment carried forward.

  3. Overall Tumor Response Rate [ Time Frame: 2 years ]

    The number of participants with a complete or partial response as measured by bone scan or PET-CT scan using. Response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

    • Complete Response (CR): Disappearance of all target lesions
    • Partial Response (PR): At least a 30% decrease in the sum of the Longest Diameter (LD) of target lesions, taking as reference the baseline sum LD

  4. MET Amplification in Tumor Sample [ Time Frame: 2 years ]
    Response will be correlated with specific tumor genotype (MET amplification).

  5. Response to Cabozantinib in Bone Metastatic Disease [ Time Frame: 2 years ]
    Response to cabozantinib in bone metastatic disease as measured by bone scan or PET-CT scan

  6. Time to SRE [ Time Frame: 2 years ]
    Time to SRE in patients treated with cabozantinib (SRE defined as pathologic fracture, cord compression, radiation or surgery to bone, hypercalcemia)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01588821

Layout table for location information
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Layout table for investigator information
Principal Investigator: Rebecca Heist, MD MGH
Layout table for additonal information
Responsible Party: Rebecca Suk Heist, MD, Principal Investigator, Massachusetts General Hospital Identifier: NCT01588821    
Other Study ID Numbers: 12-091
First Posted: May 1, 2012    Key Record Dates
Results First Posted: January 10, 2018
Last Update Posted: September 29, 2020
Last Verified: September 2020
Keywords provided by Rebecca Suk Heist, MD, Massachusetts General Hospital:
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases