- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00557609
Phase 2 Study in Patients With MiT Tumors
A Phase 2 Study of ARQ 197 in Patients With Microphthalmia Transcription Factor Associated Tumors
Study Overview
Status
Intervention / Treatment
Detailed Description
This is a multi-center, single arm, two-stage phase 2 study of ARQ 197 in patients with microphthalmia transcription factor associated (MiT) tumors. ARQ 197 is a novel small molecule drug designed to block the activity of c-Met, which is thought to play multiple key roles in human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis.
The microphthalmia transcription factor tumors (MiT tumors) are clear cell sarcoma (CCS), alveolar soft part sarcoma (ASPS), and translocation associated renal cell carcinoma (RCC). These soft tissue cancers are characterized by a common transcriptional mechanism that leads to inexorable spread and resistance to all known therapies. They tend to strike adolescents and young adults, and are invariably fatal if not resectable at diagnosis. Several academic laboratories have shown that genetic translocations in these tumors upregulate c-Met, and that such tumors are dependent upon this activity.
The study will enroll adolescent (age 13 or older) and adult patients with a histologically or cytologically confirmed MiT malignant disease. Eligible patients will receive ARQ 197 twice daily. Treatment will be continued until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.
During the study, tumor evaluations will be performed at baseline, then in 8-week intervals.
To evaluate each patient's safety and the drug's toxicity, physical examinations, laboratory evaluations, vitals signs, and adverse event assessments will be performed throughout the study. Blood samples for PK analysis will be collected during first cycle of treatment from up to 10 patients aged 20 or younger. Archival tissue specimens and relevant laboratory results on patients' gene translocation/fusion status will be collected.
Tumor biopsies may also be collected (optional) with patient's consent. If patients agree tumor samples may be collected using core needle biopsy.
In addition, to explore biological responses of tumors to ARQ 197 treatment, FDG-PET scanning will be performed at three time points: within 14 days prior to the treatment, on Day 8 (± 2 days) of Cycle 1 and after two cycles of treatment coinciding with tumor measurement.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
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London, United Kingdom, SW3 6JJ
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California
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San Francisco, California, United States, 94143
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Santa Monica, California, United States, 90404
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Florida
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Miami, Florida, United States, 33136
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Massachusetts
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Boston, Massachusetts, United States, 02115
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Ohio
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Cincinnati, Ohio, United States, 45229
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Texas
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Dallas, Texas, United States, 75201
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Houston, Texas, United States, 77030
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically or cytologically confirmed unresectable locally advanced or metastatic alveolar soft part sarcoma, clear cell sarcoma, or translocation associated renal cell carcinoma
- ≥13 years old
- Male or female patients of child-producing potential must agree to use double barrier contraception, oral contraceptives or avoidance of pregnancy measures during the study and for 30 days after the last ARQ 197 dose
- Females of childbearing potential must have a negative serum pregnancy test
Exclusion Criteria:
- Central nervous system metastasis unless it has been stable for ≥ 3 months after treatment and patient has no neural symptoms
- Pregnant or lactating
- Significant gastrointestinal disorder(s), in the opinion of a Investigator, could interfere with the absorption of ARQ 197 (e.g., Crohn's disease, ulcerative colitis, extensive gastric or small bowel resection)
- Unable or unwilling to swallow ARQ 197 capsules twice daily
- Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Bradycardia at baseline or known history of arrhythmia
- Received ARQ 197 previously
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Determine the overall response rate (ORR) in patients treated with ARQ 197
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Secondary Outcome Measures
Outcome Measure |
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Evaluate progression-free survival (PFS) time in patients treated with ARQ 197
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Evaluate 6-month and 1-year overall survival (OS) rates in patients treated with ARQ 197
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Further characterize the safety of ARQ 197 in adolescent and young adult patients with MiT tumors
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Neoplasms, Connective Tissue
- Neoplasms, Muscle Tissue
- Sarcoma
- Carcinoma, Renal Cell
- Sarcoma, Clear Cell
- Sarcoma, Alveolar Soft Part
Other Study ID Numbers
- ARQ 197-204
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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