Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations

Completed · Phase 1/Phase 2

Conditions studied: Solid Tumor

In brief

This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR genetic aberrations, including iCCA with FGFR2 gene fusion (Part 2; Expanded Cohort, signal finding).

Key facts

Study ID

NCT01752920

Run by

Basilea Pharmaceutica

People needed

119

Starts

2012-12-10

Expected to finish

2018-08-28

Last updated by the study team

2023-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed written informed consent granted
• Men or women ≥18 years of age
• Histologically or cytologically confirmed, locally advanced, inoperable, or metastatic solid tumors. Patients eligible for enrollment in the Expanded Cohort must have documented and/or confirmed FGFR genetic aberrations, including iCCA with FGFR2 gene fusion.
• 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 ≥ 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Hemoglobin (Hgb) ≥ 9.0 g/dL
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
• Platelet count ≥ 100 x 10\^9/L
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (≤ 2 x ULN for patients with cholangiocarcinoma)
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 × ULN (≤ 5 x ULN for patients with liver metastases)
• Serum creatinine ≤ 1.5 x ULN or creatinine clearance > 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
• Albumin ≥ 2.8 g/dL
• INR 0.8 to ULN or ≤ 3 for patients receiving anticoagulant therapy
• Men or women of child-producing potential must agree to use double-barrier contraceptive measures, oral contraception, 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 derazantinib.

You may not qualify if…

• Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks or five times of the drug half life, whichever is longer, of the first dose of derazantinib
• Major surgery or radiation therapy within four weeks of the first dose of derazantinib
• Previous treatment with FGFR inhibitors
• History of allergic reactions attributed to compounds of similar chemical or biological composition as derazantinib
• Unable or unwilling to swallow the complete daily dose of derazantinib
• Clinically unstable central nervous system (CNS) metastasis
• History of myocardial infarction (MI) or congestive heart failure defined as Class II to IV per the New York Heart Association classification within 6 months of the first dose of derazantinib (MI occurring >6 months of the first dose of derazantinib will be permitted)
• Significant GI disorder(s) that could interfere with the absorption, metabolism, or excretion of derazantinib (e.g. Crohn's disease, ulcerative colitis, extensive gastric resection)
• History and/or current evidence of clinically relevant ectopic mineralization/calcification
• Previous malignancy within 2 years prior to the first dose of derazantinib, except curatively treated non-melanoma skin cancer, carcinoma in-situ of the breast or cervix, or superficial bladder tumors
• Known human immunodeficiency virus (HIV) infection
• Concurrent uncontrolled illness not related to cancer, including but not limited to:
• Psychiatric illness/substance abuse/social situation that would limit compliance with study requirements.
• Uncontrolled diabetes mellitus
• Blood transfusion within 5 days of the blood draw being used to confirm eligibility
• Pregnant or breastfeeding

Where it is running

• Scottsdale Healthcare Research Institute — Scottsdale, Arizona, United States
• Emory University, Winship Cancer Institute — Atlanta, Georgia, United States
• Karmanos Cancer Institute, Detroit — Detroit, Michigan, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Montefiore-Einstein Center for Cancer Care — The Bronx, New York, United States
• University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
• START - South Texas Accelerated Research Therapeutics, LLC — San Antonio, Texas, United States
• University of Washington — Seattle, Washington, United States
• Istituto Clinico Humanitas — Milan, Italy
• Istituto Nazionale Tumori (National Cancer Institute) — Milan, Italy
• Instituto Oncologico Veneto, IRCCS — Padova, Italy
• Azienda Ospedaliero-Universitaria Pisana - U.O. Oncologia Medica 2 Univ. — Pisa, Italy

Full record on ClinicalTrials.gov

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