Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00003783

Trial Description

start of 1:1-Block title

Title

A Phase 1/Randomized Phase 2 Study to Evaluate LY2603618 in Combination With Gemcitabine in Patients With Pancreatic Cancer

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The purpose of the Phase 1 portion of this study is to determine the safe dose of LY2603618
when given 24 hours after gemcitabine. This dose will then be used for the Phase 2 portion
of the study. The Phase 2 portion of the study will evaluate whether LY2603618 when
administered 24 hours after gemcitabine therapy is an effective treatment for patients with
pancreatic cancer.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Phase 1 will be a dose escalation of doses 70 mg/m2 to 300 mg/m2 divided into 6 cohorts.
Each patient will be assigned to a single cohort with no intrapatient dose escalation.
Patients will received gemcitabine on days 1, 8, and 15 followed by LY2603618 on days 2, 9,
and 16 of each 28 day cycle. The phase 1 portion will enroll approximately 26 patients
total to determine the maximum tolerated dose to be carried into the phase 2 portion of the
study.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003783
  •   2012/05/04
  •   2009/02/06
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   NCT00839332  (ClinicalTrials.gov)
  •   12096  (Eli Lilly and Company)
  •   I2I-MC-JMMC 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Pancreatic Neoplasms
  •   C25 -  Malignant neoplasm of pancreas
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: LY2603618
  •   Drug: Gemcitabine
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   I-II
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Phase 1: Determine the maximum tolerated dose for LY2603618 when administered after gemcitabine.; time frame: Time of first dose until 28 days post dose
- Phase 2: overall survival; time frame: Baseline to date of death

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Cmax of gemcitabine and LY2603618; time frame: Phase 1: During cycles 1 and 2 Phase 2: During cycle 1
- Overall tumor response rate; time frame: baseline to measured progressive disease
- Electrocardiogram QTc prolongation; time frame: Baseline and during Cycle 1 of both Phase 1 and Phase 2 for patients receiving LY2603618
- Time to disease progression; time frame: Baseline to objective progression
- Response rate in tumor size at 8 weeks and the relationship with overall survival; time frame: Baseline to date of confirmed response and date of death from any cause
- Time to treatment failure; time frame: baseline to time of discontinuing gemcitabine and/or LY2603618 or baseline to time of starting of new therapy after discontinuing study treatment
- AUC of gemcitabine and LY2603618; time frame: Phase 1: During cycles 1 and 2 Phase 2: During cycle 1

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   United States
  •   Germany
  •   Italy
  •   Netherlands
  •   Romania
  •   Spain
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2009/03/31
  •   125
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Diagnosed with cancer that is metastatic and/or advanced during Phase 1

- Diagnosed with pancreatic cancer that is metastatic and not amenable to surgery

- Must be 18 years of age

- Adequate hematological, liver, and renal functions

- ECOG status 0-2

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Known hypersensitivity to gemcitabine

- Pregnant or lactating females or refusal to use medically approved contraceptive
precautions

- Had prior treatment with radiotherapy involving more than 25% of marrow producing
area

- Have received treatment in the last 30 days with a drug which has not received
regulatory approval for any indication at the time of study entry

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Eli Lilly and Company
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Eli Lilly and Company
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST) 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Eli Lilly and Company
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST) 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.