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Cabozantinib in Recurrent/Metastatic Merkel Cell Carcinoma

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: NCT02036476
Recruitment Status : Active, not recruiting
First Posted : January 15, 2014
Last Update Posted : July 15, 2022
Information provided by (Responsible Party):
Robert I. Haddad, MD, Dana-Farber Cancer Institute

Brief Summary:
This is an open-label, non-randomized, phase 2 study to assess the feasibility of using cabozantinib in recurrent/metastatic Merkel Cell Carcinoma patients that progressed after platinum-based therapy.

Condition or disease Intervention/treatment Phase
Merkel Cell Carcinoma Skin Cancer Drug: Cabozantinib Phase 2

Detailed Description:

Cabozantinib (XL184) is an inhibitor of multiple receptor tyrosine kinases and was approved by the U.S. Food and Drug Administration (FDA) on 29 November 2012 for the treatment of patients with progressive, metastatic medullary thyroid cancer. It is commercially available as COMETRIQ™ in the United States.

During the Pre Treatment Period, participants are consented and qualified (screened) for the study. Treatment will be administered on an outpatient basis.

Each treatment cycle lasts 28 days, during which time the participant will be taking the study drug, cabozantinib, once daily. The participant will be given a study drug-dosing diary for each treatment cycle. The diary will also include special instructions for taking the study drug.

- Participants will be followed for 8 weeks after removal from study or until death, whichever occurs first. Participants removed from study for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cabozantinib in Recurrent/Metastatic Merkel Cell Carcinoma
Actual Study Start Date : January 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Cabozantinib
Cabozantinib 60 mg Oral Daily 28 days (4 weeks)
Drug: Cabozantinib
Cabozantinib 60 mg Oral Daily 28 days (4 weeks)
Other Names:
  • XL184
  • Cometriq

Primary Outcome Measures :
  1. Disease Control Rate [ Time Frame: 3 Months ]
    The disease control rate is defined as the rate of complete response (CR), partial response (PR), or stable disease (SD) as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Secondary Outcome Measures :
  1. Progression-Free and Overall Survival [ Time Frame: 2 Years ]
    To determine progression-free survival and overall survival of patients receiving cabozantinib for Merkel Cell Carcinoma.

  2. Adverse Events [ Time Frame: 2 Years ]
    To determine the frequency and severity of adverse events as assessed by using common terminology criteria for adverse events (CTCAE) version 4.0.

  3. Expression of c-MET, phospho-MET and VEGFR-2 on tumor tissue [ Time Frame: 2 Years ]
    To retrospectively correlate the expression of c-MET, phospho-MET and VEGFR-2 on tumor tissue with clinical outcome.

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.

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

Inclusion Criteria:

  • Must have histologically or cytologically confirmed Merkel Cell Carcinoma that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective
  • Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥10 mm with spiral CT scan (see section 10 for the evaluation of measureable disease). Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented
  • Must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin or another organoplatinum compound. Patients are also eligible if they received curative intent platinum-based therapy and progressed within a year of therapy
  • No prior MET inhibitor is allowed
  • At least 2 weeks since prior chemotherapy or radiation therapy. At least 3 weeks since prior biologics or investigational agents
  • Recovery from effects of recent treatment to baseline or CTCAE ≤ grade 1 toxicity from all prior therapies except alopecia and other non-clinically significant AEs
  • Participants must be ≥18 years of age
  • ECOG performance status ≤1
  • Participants must have normal organ and marrow function
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
  • Ability to understand and the willingness to sign a written informed consent document
  • Collection of archival tissue specimens for confirmation of Merkel Cell Carcinoma

Exclusion Criteria:

  • Participants who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier
  • Participants may not be receiving any biologics or investigational agents within 3 weeks
  • The subject has active brain metastases or epidural disease
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib
  • Has prothrombin time (PT)/ International Normalized Ratio (INR) or partial thromboplastin time (PTT) test ≥ 1.3 the institutional ULN within 7 days before the first dose of study treatment, unless PT/PTT prolongation known to be secondary to conditions not associated with increased bleeding risk (as on antiphospholipid antibody syndrome)
  • Requires concomitant treatment, in therapeutic doses, with anticoagulants
  • Active bleeding or pathologic conditions that carry high risk of bleeding
  • Have experienced clinically significant gastrointestinal bleeding within 6 months before first dose of study treatment
  • Requires chronic concomitant treatment of strong CYP3A4 inducers
  • Is unable or unwilling to swallow tablets
  • Has a corrected QT interval calculated by the Fridericia formula (QTcF)>500 ms within 28 days before initiation of cabozantinib
  • Has evidence of tumor invading the GI tract or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib
  • Has radiographic evidence of cavitating pulmonary lesion(s)
  • Has uncontrolled, significant intercurrent or recent illness
  • Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy
  • History of major surgery within 3 months or minor surgery within 1 month of the first dose of cabozantinib
  • Pregnant women
  • Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy
  • HIV-positive individuals on combination antiretroviral therapy

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): NCT02036476

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
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Principal Investigator: Robert Haddad, MD Dana-Farber Cancer Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert I. Haddad, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT02036476    
Other Study ID Numbers: 13-490
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share individual participant data. Cumulative results will be posted here and published.
Keywords provided by Robert I. Haddad, MD, Dana-Farber Cancer Institute:
Merkel Cell Carcinoma
Skin Cancer
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Skin Diseases
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue