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Dose-finding Study of BI 2536 Administered in Combination With Gemcitabine in Patients With Locally Advanced or Metastatic 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. Identifier: NCT02215044
Recruitment Status : Terminated
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: BI 2536, intravenous Drug: Gemcitabine, intravenous Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2007
Actual Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BI 2536 in combination with gemcitabine Drug: BI 2536, intravenous
Drug: Gemcitabine, intravenous

Primary Outcome Measures :
  1. Occurence of dose limiting toxicity according to CTCAE [ Time Frame: up to day 28 of each cycle ]

Secondary Outcome Measures :
  1. 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 ]
  2. Maximum measured concentration of the analytes in plasma (Cmax) [ Time Frame: Pre-dose, up to 192 hours after start of treatment ]
  3. Objective tumour responses based on Response evaluation criteria in solid tumors (RECIST) criteria [ Time Frame: up to 1 year ]
  4. Survival status [ Time Frame: up to 1 year ]
  5. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

    1. have not received gemcitabine chemotherapy for locally advanced or metastatic pancreatic cancer or
    2. 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
Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02215044    
Other Study ID Numbers: 1216.8
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs