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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278458
Recruitment Status : Unknown
Verified May 2015 by Betta Pharmaceuticals Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : October 30, 2014
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
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 : October 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Gemzar




Primary Outcome Measures :
  1. The number of patients who suffer adverse events [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Tumor response assessed by RECIST 1.1 [ Time Frame: 3 months ]
  2. Progression-free survival [ Time Frame: 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278458


Locations
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China, Heilongjiang
Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150081
China, Jilin
Bethune First Hospital of Jilin University
Changchun, Jilin, China, 150081
China, Liaoning
First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 150081
Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.
Investigators
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Principal Investigator: Yanqiao Zhang, MD Cancer Hospital of Harbin Medical University

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Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02278458    
Other Study ID Numbers: BD-IC-IV70
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs