Combination of Icotinib and Gemcitabine as First-line Treatment in Pancreatic Cancer

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02278458
• Other study ID #: BD-IC-IV70
• Status: Active, not recruiting
• Phase: Phase 1
• First received: October 28, 2014
• Last updated: May 21, 2015
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: May 2015
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: October 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• icotinib
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
Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.

Locations

Country	Name	City	State
China	Bethune First Hospital of Jilin University	Changchun	Jilin
China	Cancer Hospital of Harbin Medical University	Harbin	Heilongjiang
China	First Affiliated Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients who suffer adverse events		24 months	Yes
Secondary	Tumor response assessed by RECIST 1.1		3 months	No
Secondary	Progression-free survival		4 months	No