Dose-finding Study of BI 2536 Administered in Combination With Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Boehringer Ingelheim

Status and phase

Terminated

Phase 1

Conditions

Pancreatic Neoplasms

Treatments

Drug: Gemcitabine, intravenous

Drug: BI 2536, intravenous

Study type

Interventional

Funder types

Industry

Identifiers

NCT02215044

1216.8

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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