- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02215044
Dose-finding Study of BI 2536 Administered in Combination With Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer
August 12, 2014 updated by: Boehringer Ingelheim
A Phase I Open-label Dose-finding Study of Intravenous BI 2536 Administered in Repeated 4-week Cycles as Repeated Doses on Day 1 and Day 15 in Combination With Gemcitabine Administered on Day 1, Day 8 and Day 15 in Patients With Locally Advanced or Metastatic Pancreatic Cancer
Determination of the maximum tolerated dose (MTD), safety, and tolerability when BI 2536 was given on Day 1 and Day 15 in combination with gemcitabine given on Day 1, Day 8 and Day 15 every 28 days in patients with locally advanced or metastatic pancreatic adenocarcinoma and characterisation the antitumor activity, pharmacokinetic (PK) profile, and CA 19-9 tumor marker response in response to the combination of BI 2536 with gemcitabine in patients with locally advanced or metastatic pancreatic adenocarcinoma.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patient with histologically or cytologically confirmed locally advanced, unresectable or metastasized adenocarcinoma of the pancreas who:
- have not received gemcitabine chemotherapy for locally advanced or metastatic pancreatic cancer or
- have progressive disease not before at least 6 months from cessation of adjuvant gemcitabine chemotherapy following curative surgical tumor resection
- Male or female patient aged 18 years or older
- Life expectancy of at least three (3) months
- Eastern Co-operative Oncology Group (ECOG) performance score of 2 or less
- Patient must have given written informed consent
Exclusion Criteria:
- Prior chemo- (other than adjuvant gemcitabine), hormone- (other than Megace®) or immunotherapy
- Ampullary carcinoma of the pancreas
- Brain metastases, which are symptomatic or require therapy
- Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
- Other malignancies diagnosed within the past five (5) years (other than non-melanomatous skin cancer)
- Absolute neutrophil count (ANC) <1,500/μl, platelet count <150,000/μl, or hemoglobin <9 g/dl
- Total bilirubin >1.8mg/dl (>30.78 μmol/l,, international system of units (SI) equivalent) under adequate drainage measures (in case of obstructive jaundice)
- No hepatic metastases: Aspartate amino transferase (AST) and/or alanine amino transferase (ALT) >2.5 x upper limit of normal (ULN). Hepatic metastases: aspartate amino transferase (AST) and/or alanine amino transferase (ALT) >5 x ULN
- Serum creatinine >2.0 mg/dl (>176 μmol/L, SI Unit equivalent)
- Radiotherapy within the last 2 weeks prior to or during treatment with the trial drug
- Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents)
- Patients with known HIV, Hepatitis-B or -C infection
- Known or suspected active drug or alcohol abuse
- Women of child-bearing potential; men who are able to father a child and are unwilling to use a medically acceptable method of contraception during the trial
- Pregnancy or breast feeding
- Treatment with any investigational drug within the past 4 weeks or within less than four half-life times of the investigational drug before treatment with the trial drug and/or persistence of toxicities of prior anticancer therapies which are deemed to be clinically relevant
- Patient unable to comply with the protocol
- Patients requiring warfarin (Coumadin®) or patients with a known pre-existing coagulopathy unrelated to pancreatic cancer (This means, for example, that patient with a long (years) history or recurrent venocclusive disease clearly preceding the diagnosis of pancreatic cancer will be excluded from the study. Patients with recent hypercoagulable state (ie deep vein thrombosis or pulmonary embolism) due to pancreatic cancer who are clinically stable on low molecular weight heparin will not be excluded)
- Patients with neuropathy (sensory or motor) ≥ common terminology criteria for adverse events (CTCAE) 3
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BI 2536 in combination with gemcitabine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurence of dose limiting toxicity according to CTCAE
Time Frame: up to day 28 of each cycle
|
up to day 28 of each cycle
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞)
Time Frame: Pre-dose, up to 192 hours after start of treatment
|
Pre-dose, up to 192 hours after start of treatment
|
Maximum measured concentration of the analytes in plasma (Cmax)
Time Frame: Pre-dose, up to 192 hours after start of treatment
|
Pre-dose, up to 192 hours after start of treatment
|
Objective tumour responses based on Response evaluation criteria in solid tumors (RECIST) criteria
Time Frame: up to 1 year
|
up to 1 year
|
Survival status
Time Frame: up to 1 year
|
up to 1 year
|
Tumor marker (CA19-9) response to treatment with BI 2536 and gemcitabine
Time Frame: Day 1 of each treatment cycle prior to administration of study treatment
|
Day 1 of each treatment cycle prior to administration of study treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
August 7, 2014
First Submitted That Met QC Criteria
August 12, 2014
First Posted (Estimate)
August 13, 2014
Study Record Updates
Last Update Posted (Estimate)
August 13, 2014
Last Update Submitted That Met QC Criteria
August 12, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- 1216.8
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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