NCT00557609

Brief Summary

This is a multi-center, single arm intended to evaluate the anti-tumor effect of ARQ 197 in patients with microphthalmia transcription factor associated (MiT) tumors. MiT tumors include clear cell sarcoma, alveolar soft parts sarcoma, and translocation associated renal cell carcinoma.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2007

Typical duration for phase_2

Geographic Reach
3 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

3.2 years

First QC Date

November 12, 2007

Last Update Submit

February 6, 2013

Conditions

Renal Cell Carcinoma (RCC)Alveolar Soft Part Sarcoma (ASPS)Clear Cell Sarcoma (CCS)

Keywords

Microphthalmia transcription (MiT) factor associated tumorsAlveolar soft part sarcoma (ASPS)Clear cell sarcoma (CCS)Renal cell carcinoma (RCC)

Outcome Measures

Primary Outcomes (1)

  • Determine the overall response rate (ORR) in patients treated with ARQ 197

Secondary Outcomes (3)

  • Evaluate progression-free survival (PFS) time in patients treated with ARQ 197

  • Evaluate 6-month and 1-year overall survival (OS) rates in patients treated with ARQ 197

  • Further characterize the safety of ARQ 197 in adolescent and young adult patients with MiT tumors

Interventions

ARQ 197DRUG

360 mg administered twice daily until disease progression or other discontinuation criterion is met

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Unknown Facility

San Francisco, California, 94143, United States

Location

Unknown Facility

Santa Monica, California, 90404, United States

Location

Unknown Facility

Miami, Florida, 33136, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Cincinnati, Ohio, 45229, United States

Location

Unknown Facility

Dallas, Texas, 75201, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Toronto, Ontario, M5G 2M9, Canada

Location

Unknown Facility

London, SW3 6JJ, United Kingdom

Location

Related Publications (1)

  • Wagner AJ, Goldberg JM, Dubois SG, Choy E, Rosen L, Pappo A, Geller J, Judson I, Hogg D, Senzer N, Davis IJ, Chai F, Waghorne C, Schwartz B, Demetri GD. Tivantinib (ARQ 197), a selective inhibitor of MET, in patients with microphthalmia transcription factor-associated tumors: results of a multicenter phase 2 trial. Cancer. 2012 Dec 1;118(23):5894-902. doi: 10.1002/cncr.27582. Epub 2012 May 17.

    PMID: 22605650DERIVED

MeSH Terms

Conditions

Carcinoma, Renal CellSarcoma, Alveolar Soft PartSarcoma, Clear Cell

Interventions

ARQ 197

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueSarcomaNeoplasms, Connective Tissue

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2007

First Posted

November 14, 2007

Study Start

October 1, 2007

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

February 8, 2013

Record last verified: 2013-02

Locations

GB(1)US(7)CA(1)