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

Sponsor

Betta Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02278458

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: icotinib Drug: Gemcitabine	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

Jan 1, 2016

Anticipated Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: icotinib plus gemcitabine 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.	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. Other Names: Commana Drug: Gemcitabine Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks. Other Names: Gemzar

Arm

Intervention/Treatment

Experimental: icotinib plus gemcitabine

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.

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.

Other Names:

Commana

Drug: Gemcitabine

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

Other Names:

Gemzar

Outcome Measures

Primary Outcome Measures

The number of patients who suffer adverse events [24 months]

Secondary Outcome Measures

Tumor response assessed by RECIST 1.1 [3 months]
Progression-free survival [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150081
2	Bethune First Hospital of Jilin University	Changchun	Jilin	China	150081
3	First Affiliated Hospital of China Medical University	Shenyang	Liaoning	China	150081

Sponsors and Collaborators

Betta Pharmaceuticals Co., Ltd.

Investigators

Principal Investigator: Yanqiao Zhang, MD, Cancer Hospital of Harbin Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Betta Pharmaceuticals Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02278458

Other Study ID Numbers:

BD-IC-IV70

First Posted:

Oct 30, 2014

Last Update Posted:

May 22, 2015

Last Verified:

May 1, 2015

Additional relevant MeSH terms:

Pancreatic Neoplasms

Gemcitabine

Study Results

No Results Posted as of May 22, 2015