Dose-finding Study Of BI 2536 Administered In Combination With Gemcitabine In Patients With Locally Advanced Or Metastatic Pancreatic Cancer

Study Overview

Dose-finding Study of BI 2536 Administered in Combination With Gemcitabine 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.

N/A

Pancreatic Neoplasms

DRUG: BI 2536, intravenous
DRUG: Gemcitabine, intravenous

1216.8

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-08-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2014-08-12
First Submitted that Met QC Criteria 2014-08-12	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2014-08-13
First Posted (ESTIMATED) 2014-08-13	Results First Posted N/A	Last Verified 2014-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: BI 2536 in combination with gemcitabine	DRUG: BI 2536, intravenous DRUG: Gemcitabine, intravenous

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: BI 2536 in combination with gemcitabine

DRUG: BI 2536, intravenous

DRUG: Gemcitabine, intravenous

Primary Outcome Measures	Measure Description	Time Frame
Occurence of dose limiting toxicity according to CTCAE		up to day 28 of each cycle

Secondary Outcome Measures	Measure Description	Time Frame
Area under the concentration-time curve of the analytes in plasma from time zero to infinity (AUC0-∞)		Pre-dose, up to 192 hours after start of treatment
Maximum measured concentration of the analytes in plasma (Cmax)		Pre-dose, up to 192 hours after start of treatment
Objective tumour responses based on Response evaluation criteria in solid tumors (RECIST) criteria		up to 1 year
Survival status		up to 1 year
Tumor marker (CA19-9) response to treatment with BI 2536 and gemcitabine		Day 1 of each treatment cycle prior to administration of study treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patient with histologically or cytologically confirmed locally advanced, unresectable or metastasized adenocarcinoma of the pancreas who:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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