ARQ 197 for Subjects With Relapsed or Refractory Germ Cell Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT01055067
First received: January 21, 2010
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

This is a multicenter, single-arm study for safety and efficacy.


Condition Intervention Phase
Non-CNS Germ Cell Tumors (Seminomas and Nonseminomas)
Drug: Tivantinib (ARQ 197)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Phase 2 Trial of ARQ 197 for Subjects With Relapsed or Refractory Germ Cell Tumors

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • To determine the objective response rate after 4 cycles of therapy with ARQ 197 in subjects with GCT [ Time Frame: approximately 112 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the progression free survival (PFS) rate at 12-weeks. To determine median overall survival among subjects treated with ARQ 197. To determine safety and tolerability of ARQ 197 in this subject population [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tivantinib (ARQ 197)
3 capusles of 120 mg each, administered twice a day (once in the morning and once in the evening - total daily dose of 720 mg) in continuous 4-week cycles
Drug: Tivantinib (ARQ 197)
Capsule, 120 mg, BID (360 mg), approximately 112 days
Other Name: Tivantinib

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically-confirmed non-CNS GCT, both seminomas and nonseminomas are allowed.
  2. Male subjects 16 years of age or older.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of equal to or less than 1.
  4. Documented progression during or following equal to or greater than 1 prior platinum-containing chemotherapy regimen(s) (no limit to number of lines of prior treatment), and considered platinum-resistant by the Investigator. Subjects who have progressed or whose tumors have recurred after stem cell transplantation are also allowed.
  5. All subjects must have either declined or not be a candidate for curative therapy. In general, this means a subject would have to have progressive disease (PD) after receiving high-dose chemotherapy, have certain features making them ineligible for high-dose chemotherapy, or have refused high-dose chemotherapy despite being informed of its curative potential.
  6. Subjects must have radiographically measurable disease as defined by RECIST 1.1 and meet one of the following criteria:

    • Documented germ cell tumor progression based on radiographic measurements;
    • Elevated serum tumor markers in case of radiographically measured stable disease.
  7. Subjects should be able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or chronic co-morbidity that would interfere with therapy.
  8. Subjects must agree to use double-barrier contraceptive measures or avoidance of intercourse during the study and for 90 days after the last dose of study drug.
  9. Adequate bone marrow, liver, and renal functions, defined as:

    • Platelet count equal to or greater than 75 times 10^9/L;
    • Hemoglobin equal to or greater than 9.0 g/dL;
    • Absolute neutrophil count (ANC) equal to or greater than 1.5 times 10^9/L;
    • Total bilirubin equal to or less than 2.5 mg/dL;
    • Alanine aminotransaminase (ALT) and aspartate aminotransaminase (AST) equal to or less than 2.5 times the upper limit of normal (ULN) (equal to or less than 5 times the ULN for subjects with liver metastases);
    • Serum creatinine equal to or less than 1.5 times the ULN.
  10. Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an Independent Ethics Committee or Institutional Review Board approved informed consent form (including Health Insurance Portability and Accountability Act authorization, if applicable) before performance of any study specific procedures or tests.

Exclusion Criteria:

  1. Previous or concurrent cancer that is distinct from GCT in primary site or histology, EXCEPT treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated equal to or greater than 3 years prior to enrollment is permitted.
  2. History of cardiac disease:

    • Congestive heart failure defined as Class II to IV per New York Heart Association classification.
    • Active coronary artery disease.
    • Previously diagnosed bradycardia or other cardiac arrhythmia defined as equal to or greater than Grade 2 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, or uncontrolled hypertension.
    • Myocardial infarction that occurred within 6 months prior to study entry (myocardial infarction that occurred greater than 6 months prior to study entry is permitted).
  3. Active clinically serious infection(s) defined as equal to or greater than Grade 2 according to NCI CTCAE, version 4.0.
  4. Known metastatic brain or meningeal tumors, unless the subject is greater than 6 months from definitive therapy, has a negative imaging study within 4 weeks of first dose of study drug and is clinically stable (no concomitant therapy, including supportive therapy with steroids or anticonvulsant medications) with respect to the tumor at the time of first dose of study drug.
  5. Any primary CNS GCT.
  6. Concurrent treatment with anticancer therapies including cytotoxic chemotherapy, immunotherapy, radiotherapy, vaccines or investigational therapy during the study or within 3 weeks of first dose of study drug.
  7. Any major surgical procedure within 3 weeks prior to first dose of study drug.
  8. Prior therapy with c-MET inhibitors, including ARQ197.
  9. Substance abuse or medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.
  10. Any condition that is unstable or that could jeopardize the safety of the subject and the subject's protocol compliance, including known human immunodeficiency virus, hepatitis B virus or hepatitis C virus infection.
  11. Inability to swallow oral medications.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055067

Locations
United States, California
Los Angeles, California, United States, 90033
United States, Florida
Orlando, Florida, United States, 32806
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, New York
New York, New York, United States, 10065
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
France
Lyon cedex, France, 69373
Villejuif, France, 94800
United Kingdom
Leeds, United Kingdom, LS9 7TF
London, United Kingdom, SM2 5PT
Sponsors and Collaborators
Daiichi Sankyo Inc.
Investigators
Principal Investigator: Darren Feldman, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT01055067     History of Changes
Other Study ID Numbers: ARQ 197-A-U251
Study First Received: January 21, 2010
Last Updated: September 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 22, 2014