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ARQ 197 for Participants With Relapsed or Refractory Germ Cell Tumors

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.
 
ClinicalTrials.gov Identifier: NCT01055067
Recruitment Status : Terminated (The study was terminated early for futility according to the stopping rule of the Simon 2-stage design.)
First Posted : January 25, 2010
Results First Posted : September 9, 2020
Last Update Posted : September 29, 2020
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase 2 Trial of ARQ 197 for Subjects With Relapsed or Refractory Germ Cell Tumors
Actual Study Start Date : February 2, 2010
Actual Primary Completion Date : November 30, 2011
Actual Study Completion Date : November 30, 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tivantinib (ARQ 197)
3 capsules 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




Primary Outcome Measures :
  1. Best Overall Response and Objective Response Rate Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors [ Time Frame: Baseline up to first objective response, up to 1 year 9 months postdose ]
    The best overall response was the best response (in the order of confirmed complete response [CR], confirmed partial response [PR], unconfirmed CR, unconfirmed PR, stable disease [SD], and progressive disease [PD]) among all overall responses recorded from the start of treatment until the participant withdrew from the study. Objective response was defined as the number of participants with confirmed CR and confirmed PR after 4 cycles of therapy with ARQ 197. According to Response Evaluation Criteria in Solid Tumors v 1.1, CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, defined as at least a 20% increase in the sum of diameters of target lesions.


Secondary Outcome Measures :
  1. Progression-Free Survival Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors [ Time Frame: Baseline up to progressive disease or death (whichever occurs first), up to 1 year 9 months postdose ]
    Progression-free survival (PFS) is defined as the time from the date of the start of study treatment to the earlier of the dates of the first documentation of progressive disease (PD) or death due to any cause. According to Response Evaluation Criteria in Solid Tumors v 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions.

  2. Overall Survival Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors [ Time Frame: Baseline up to death (any cause), up to 1 year 9 months postdose ]
    Overall survival (OS) was defined as the time from the date of the start of study treatment to the date of death due to any cause.

  3. Treatment-Emergent Adverse Events Reported in ≥ 10% of Participants Following Treatment With Tivantinib (ARQ 197) in Participants With Relapsed or Refractory Germ Cell Tumors [ Time Frame: Baseline up to 30 days after last dose, up to 1 year 9 months postdose ]
    Treatment-emergent adverse events (TEAEs) were defined as an adverse event (AE) that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the first dose until 30 days after the last dose.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically-confirmed non-central nervous system germ cell tumor (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.

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 ClinicalTrials.gov identifier (NCT number): NCT01055067


Locations
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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
Saint 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
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Study Director: Clinical Study Leader Daiichi Sankyo, Inc.
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01055067    
Other Study ID Numbers: ARQ197-A-U251
First Posted: January 25, 2010    Key Record Dates
Results First Posted: September 9, 2020
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Seminoma
Neoplasms by Histologic Type
Neoplasms
Germinoma