A Phase 1 Study of ARQ 197 in Adult Patients With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Brief Summary

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To determine the safety, tolerability and recommended Phase 2 dose of ARQ 197 when administered in combination with erlotinib to patients with advanced solid tumors

Detailed Description

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Conditions

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Cancer

Keywords

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Cancer, oral, erlotinib, tarceva, solid tumor, advanced tumor, phase 1 Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ARQ 197

Treatment with ARQ 197 in combination with erlotinib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
* A histologically or cytologically confirmed solid tumor that is advanced, metastatic, and/or inoperable following prior standard chemotherapy, and/or for which, in the opinion of the investigator, there is no alternative therapy, or for which monotherapy with erlotinib is appropriate
* ≥ 18 years of age
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)

Exclusion Criteria

* Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose (patients currently on erlotinib monotherapy may be enrolled into the study without a washout)
* Major surgery within 4 weeks prior to first dose
* Central nervous system metastasis unless it has been stable for ≥ 3 months after treatment and patient has no neural symptoms
* Pregnant or breastfeeding
* Significant gastrointestinal disorder that, in the opinion of the Investigator, could interfere with the absorption of ARQ 197 and/or erlotinib (e.g. significant, uncontrolled inflammatory bowel disease or extensive small bowel resection)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lee Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

Premiere Oncology of Santa Monica

Richard G Just, MD

Role: PRINCIPAL_INVESTIGATOR

Pacific Oncology and Hematology Associates

Locations

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San Diego Pacific Oncology and Hematology Associates Inc.

Encinitas, California, United States

Site Status

Premiere Oncology

Santa Monica, California, United States

Site Status

Countries

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United States

References

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Goldman JW, Laux I, Chai F, Savage RE, Ferrari D, Garmey EG, Just RG, Rosen LS. Phase 1 dose-escalation trial evaluating the combination of the selective MET (mesenchymal-epithelial transition factor) inhibitor tivantinib (ARQ 197) plus erlotinib. Cancer. 2012 Dec 1;118(23):5903-11. doi: 10.1002/cncr.27575. Epub 2012 May 17.

Reference Type DERIVED

PMID: 22605616 (View on PubMed)

Other Identifiers

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ARQ 197-111

Identifier Type: -

Identifier Source: org_study_id