Study on the activity and safety of the FGFR inhibitor drug, INCB054828, in patients with advanced gastric adenocarcinoma, resistant to trastuzumab

Phase 1

• Conditions: advanced esophageal-gastric junction (EGJ)/Gastric cancer Trastuzumab resistant; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-004522-14-IT
• Lead Sponsor: Centro Ricerche Cliniche di Verona

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-30
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

•Histologically confirmed advanced or metastatic adenocarcinoma of the stomach and the gastroesophageal junction.
•Disease progression within 3 months of the last dose of first-line trastuzumab containing therapy.
•Patients must have performed a fresh biopsy (at least 8-10 slides with >20% tumor content) at the baseline of study enrollment.
•At least one measurable and evaluable disease site based on response evaluation criteria in solid tumors (RECIST v1.1).
•Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.
•Age =18, no age upper limit unless patient would be unable to tolerate chemotherapy.
•An expected survival of more than 3 months.
•Duration from the last therapy is more than 4 weeks for other cytotoxic agents, operation or radiotherapy.
•Major organ function has to meet the following criteria
oHemoglobin (Hb)>8 g/dL
oPLT >75 X 109/L
oANC >1.5 X 109/L
•Absence of pregnacy or breastfeeding.
•Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men shall agree to take appropriate methods of contraception during the study until the 8th week post the last administration of study drug.
•Patients must be accessible to follow-up and management in the treatment center.
•Patient has to voluntarily join the study and sign the Informed Consent Form for the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

•Current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjuntivitis etc, confirmed by ophthalmologic examination.
•Any active malignancies except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix.
•Poor-controlled arterial hypertension (sistolic blood pressure >140 mmHg and diastolic blood pressure >90 mmHg) despite standard medical management.
•Serious cardiovascular disease: II level myocardial ischemia or myocardial infarction, arrhytmia (including QT interval prolongation, for man > 450ms, for woman > 470 ms); III-IV level cardiac function insufficiency, or echocardiography showed that left ventricular ejection fraction (LVEF) < 50%.
•Positive urinary protein (urine protein detection of 2 or more, or 24 hour urine protein >1.0 g).
•Total bilirubin = 1.5 × upper limit of normal (ULN; = 2.5 × ULN if Gilbert syndrome or metastatic disease involving liver).
•AST and ALT > 2.5 × ULN (AST and ALT > 5 × ULN in the presence of liver metastases).
•Creatinine clearance = 30 mL/min based on Cockroft-Gault
•Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction).
•Serum phosphate > institutional ULN.
•Serum calcium outside of the institutional normal range or serum albumin-corrected calcium outside of the institutional normal range when serum albumin is outside of the institutional normal range.
•History of calcium/phosphate homeostasis disorder.
•History and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcification.
•Current evidence of significant corneal disorder/keratopathy or retinal disorder, confirmed by ophthalmologic examination.
•Factors of high gastrointestinal bleeding risk, including the following conditions: local active ulcer lesions with positive fecal occult blood test (++); history of black stool, or vomiting blood in the past 2 months; unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by Pis based on gastric endoscopy result.
•Abnormal Coagulation (INR >1.5 APTT >1.5 UNL), with tendency of bleed.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified