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A Phase I Study of ARQ 197 in Combination With Erlotinib in CYP2C19 Poor Metabolizer Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer


Phase 1
20 Years
N/A
Not Enrolling
Both
Advanced/Recurrent Non-small-cell Lung Cancer

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Trial Information

A Phase I Study of ARQ 197 in Combination With Erlotinib in CYP2C19 Poor Metabolizer Patients With Advanced/Recurrent Non-Small-Cell Lung Cancer


Inclusion Criteria:



- Voluntary written informed consent for study participation must be obtained

- A histologically or cytologically confirmed advanced/recurrent non-small-cell lung
cancer

- History of ≥1 prior chemotherapy regimen (treatment with EGFR tyrosine kinase
inhibitors will be counted as one regimen)

- ECOG PS of 0 or 1

- Life expectancy of ≥3 months

- Poor metabolizers as defined by CYP2C19 genotype

Exclusion Criteria:

- Anti-cancer chemotherapy, anti-cancer therapy with EGFR-TKI, hormone therapy,
radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody
therapy within 28 days prior to ARQ 197 dose

- Surgery for cancer within 28 days prior to ARQ 197 dose

- Active double cancer

- Known symptomatic brain metastases

- An intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive
heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial
pneumonia)

- Pregnant or lactating

- Subjects who wish to have a child and who would not agree to use contraceptive
measures

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Dose-Limiting Toxicity

Safety Issue:

Yes

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

ARQ 197-005

NCT ID:

NCT01251796

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Advanced/Recurrent Non-small-cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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