A Phase 1 Dose Escalation Study of ARQ 171 in Adult Patients With Advanced Solid Tumors
- Signed written informed consent must be obtained and documented prior to
study-specific screening procedures.
- A histologically or cytologically confirmed advanced solid tumor
- ≥ 18 years of age
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
- Karnofsky performance status ≥ 70%
- Male or female patients of child-producing potential must agree to use contraception
or avoidance of pregnancy measures during the study and for 30 days after
- Females of childbearing potential must have a negative serum pregnancy test.
- Laboratory results must meet study criteria.
- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents
within four weeks of first infusion
- Surgery within 4 weeks prior to first infusion
- Known untreated brain metastases
- Pregnant or breastfeeding
- Uncontrolled intercurrent illness, or uncontrolled infection or psychiatric
illness/social situations that would limit compliance with study requirements
- Other cancer within the last five years, with the exception of adequately treated
cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell
carcinoma of the skin