NCT02278458

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1 pancreatic-cancer

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_1 pancreatic-cancer

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

1.3 years

First QC Date

October 28, 2014

Last Update Submit

May 21, 2015

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • The number of patients who suffer adverse events

    24 months

Secondary Outcomes (2)

  • Tumor response assessed by RECIST 1.1

    3 months

  • Progression-free survival

    4 months

Study Arms (1)

icotinib plus gemcitabine

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.

Drug: icotinibDrug: Gemcitabine

Interventions

icotinibDRUG

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.

Also known as: Commana
icotinib plus gemcitabine
GemcitabineDRUG

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

Also known as: Gemzar
icotinib plus gemcitabine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

Bethune First Hospital of Jilin University

Changchun, Jilin, 150081, China

Location

First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 150081, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

icotinibGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Yanqiao Zhang, MD

    Cancer Hospital of Harbin Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2014

First Posted

October 30, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2016

Study Completion

October 1, 2016

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

CN(3)