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A Phase 1 Dose Escalation Study of ARQ 087 in Adult Subjects With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Solid Tumor

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Trial Information

A Phase 1 Dose Escalation Study of ARQ 087 in Adult Subjects With Advanced Solid Tumors

Inclusion Criteria:

- Men or women ≥18 years of age

- Histologically or cytologically confirmed, locally advanced, inoperable, or
metastatic solid tumors

- Failure to respond to standard therapy, or for whom standard therapy does not exist.

- Evaluable or measurable disease

- Archival and/or fresh biopsy tissue samples must be available prior to the first dose
of the study drug

- Life expectancy greater than 12 weeks

- Eastern Cooperative Oncology Group (ECOG) performance status ≤2

- Hemoglobin (Hgb) ≥9.0 g/dl

- Absolute neutrophil count (ANC) ≥1.5 x 109/L

- Platelet count ≥100 x 109/L

- Total bilirubin ≤1.5 × upper limit of normal (ULN)

- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 × ULN (≤5 for subjects
with liver metastases)

- Serum creatinine ≤1.5 x ULN or creatinine clearance > 60 mL/min/1.73 m2 for subjects
with creatinine levels above institutional normal

- Men or women of child-producing potential must agree to use double-barrier
contraceptive measures or avoid intercourse during the study and for 90 days after
the last dose of study drug

- Women of childbearing potential must have a negative serum pregnancy test during
Screening Period and within 48 hours of the first dose of ARQ 087.

Exclusion Criteria:

- Anti-cancer chemotherapy, immunotherapy, or investigational agents within four weeks
or five times of the drug half life, whichever is longer, of the first dose of ARQ

- Major surgery or radiation therapy within four weeks of the first dose of ARQ 087

- Previous treatment with FGFR inhibitors

- History of allergic reactions attributed to compounds of similar chemical or
biological composition as ARQ 087

- Unable or unwilling to swallow the complete daily dose of ARQ 087

- Clinically unstable central nervous system (CNS) metastasis

- History of myocardial infarction (MI) or New York Heart Association (NYHA) Class
II-IV congestive heart failure within 6 months of the administration of the first
dose of ARQ 087 (MI occurring >6 months of the first dose of ARQ 087 will be

- Significant GI disorder(s) that could interfere with the absorption, metabolism, or
excretion of ARQ 087 (e.g. Crohn's disease, ulcerative colitis, extensive gastric

- History and/or current evidence of clinically relevant ectopic

- Previous other malignancy within 2 years prior to the first dose of ARQ 087, with the
exception of curatively treated non-melanoma skin cancer, carcinoma in-situ of the
breast or cervix, or superficial bladder tumors

- Concurrent severe uncontrolled illness not related to cancer, including:

- Ongoing or active known infection, including human immunodeficiency virus (HIV)
infection or bleeding

- Psychiatric illness/substance abuse/social situation that would limit compliance
with study requirements.

- Uncontrolled diabetes mellitus

- Blood transfusion within 5 days prior to blood draw being used to confirm eligibility

- Pregnant or breastfeeding

Type of Study:


Study Design:

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

Outcome Measure:

Assess the safety and tolerability of ARQ 087 in subjects with advanced solid tumors by monitoring frequency and severity of adverse events

Outcome Time Frame:

Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 24 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:

ARQ 087-101



Start Date:

December 2012

Completion Date:

June 2016

Related Keywords:

  • Solid Tumor
  • FGFR
  • Neoplasms



Austin, Texas  78705
Flint, Michigan  48532