NCT00612703

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 cancer

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

January 30, 2008

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 12, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Last Updated

July 23, 2012

Status Verified

July 1, 2012

Enrollment Period

2.6 years

First QC Date

January 30, 2008

Last Update Submit

July 20, 2012

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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

    No time frame

Secondary Outcomes (2)

  • To determine the pharmacokinetic profiles of ARQ 197 and erlotinib, when administered in combination to patients with advanced solid tumors

    No time frame

  • To assess the preliminary anti-tumor activity of ARQ 197 when administered in combination with erlotinib to adult patients with advanced solid tumors

    No time frame

Interventions

ARQ 197DRUG

Treatment with ARQ 197 in combination with erlotinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Diego Pacific Oncology and Hematology Associates Inc.

Encinitas, California, 92024, United States

Location

Premiere Oncology

Santa Monica, California, 90404, United States

Location

Related Publications (1)

  • 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.

    PMID: 22605616DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

ARQ 197

Study Officials

  • Lee Rosen, MD

    Premiere Oncology of Santa Monica

    PRINCIPAL INVESTIGATOR

  • Richard G Just, MD

    Pacific Oncology and Hematology Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2008

First Posted

February 12, 2008

Study Start

February 1, 2008

Primary Completion

September 1, 2010

Last Updated

July 23, 2012

Record last verified: 2012-07

Locations

US(2)