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A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Advanced/Recurrent Solid Tumors


Phase 1
20 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Phase 1 Dose Escalation Study of ARQ 197 in Adult Patients With Advanced/Recurrent Solid Tumors


Inclusion Criteria:



- Patients who did not respond or are refractory to available therapy or for whom no
standard effective systemic therapy exists.

- Karnofsky performance status (KPS) ≥ 70%, or Eastern Cooperative Oncology Group
(ECOG) performance status 0 to 1

- Patients with adequate organ function

Exclusion Criteria:

- Anti-cancer chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or
investigational agents within 4 weeks prior to the first dose of ARQ 197

- Known symptomatic brain metastases

- Pregnant or breastfeeding

- Uncontrolled intercurrent illness

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 197

Safety Issue:

Yes

Principal Investigator

Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Kyowa Hakko Kirin Company, Limited

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

ARQ 197-0701

NCT ID:

NCT00609921

Start Date:

January 2008

Completion Date:

Related Keywords:

  • Cancer

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