Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments icotinib, gemcitabine
Phase phase 1
Target EGFR
Sponsor Betta Pharmaceuticals Co.,Ltd.
Start date October 2014
End date January 2016
Trial size 24 participants
Trial identifier NCT02278458, BD-IC-IV70

Summary

Research Hypothesis: icotinib administered in combination with gemcitabine has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.The primary objective is to determine the safety profile of icotinib in combination with gemcitabine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Three dose of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity. Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.
icotinib Commana
Three dose levels of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity.
gemcitabine Gemzar
Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.

Primary Outcomes

Measure
The number of patients who suffer adverse events
time frame: 24 months

Secondary Outcomes

Measure
Tumor response assessed by RECIST 1.1
time frame: 3 months
Progression-free survival
time frame: 4 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Locally advanced, unresectable or metastatic pancreatic cancer by histologic or cytologic confirmation without previous chemotherapy or target therapy. - ECOG Performance Status of 0 to 1. - Adequate organ function as defined by study-specified laboratory tests. - Signed informed consent form. - Willing and able to comply with study procedures. Exclusion Criteria: - Previous chemotherapy or target therapy. - Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions. - Systemically active steroids. - Another investigational product within 28 days prior to receiving study drug. - Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring within 28 days prior to receiving study drug. - Infection with HIV, hepatitis B or C at screening. - Pregnant or lactating. - Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures.

Additional Information

Official title Phase I, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of Icotinib Combined With Gemcitabine as First-line Treatment in Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
Principal investigator Yanqiao Zhang, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Betta Pharmaceuticals Co.,Ltd..