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

NCT02215044 | Terminated Phase 1

• 1 other identifier: 1216.8
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Occurence of dose limiting toxicity according to CTCAE

  up to day 28 of each cycle

Secondary Outcomes (5)

• 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

Study Arms (1)

BI 2536 in combination with gemcitabine

EXPERIMENTAL

Drug: BI 2536, intravenous; Drug: Gemcitabine, intravenous

Interventions

BI 2536, intravenous DRUG

BI 2536 in combination with gemcitabine

Gemcitabine, intravenous DRUG

BI 2536 in combination with gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

BI 2536; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 13, 2014
• Study Start: June 1, 2007
• Primary Completion: December 1, 2008
• Last Updated: August 13, 2014

Record last verified: 2014-08