Clinical Trials Logo
  1. Home
  2. Pancreatic Neoplasms
  3. NCT02215044

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

Pancreatic Neoplasms Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02215044
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Terminated
Phase Phase 1
Start date June 2007
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04085055 - Fine Needle Biopsy of Solid Pancreatic Mass Lesions N/A
Recruiting NCT01950572 - Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Terminated NCT00529113 - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Phase 1
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Recruiting NCT04809935 - EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy Phase 4
Recruiting NCT05481476 - Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer Phase 2
Not yet recruiting NCT04652271 - International Pancreatic Surgery Outcomes Study - PancreasGroup.Org
Active, not recruiting NCT02950064 - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations Phase 1
Completed NCT03054987 - Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction N/A
Completed NCT02909530 - Comparison Between Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in EUS-guided FNB of Solid Pancreatic Masses N/A
Completed NCT02374411 - Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients N/A
Completed NCT01770405 - Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract N/A
Terminated NCT01313416 - Gemcitabine and CT-011 for Resected Pancreatic Cancer Phase 2
Terminated NCT01515046 - Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer Phase 2
Enrolling by invitation NCT01465425 - Extracolonic Findings on Computed Tomography (CT) Colonography
Terminated NCT01434459 - Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin Phase 1
Completed NCT00985777 - Vitamin E δ-Tocotrienol Administered to Subjects With Resectable Pancreatic Exocrine Neoplasia Phase 1
Completed NCT00385177 - Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT00178763 - Hyperthermia With Chemotherapy for Locally Advanced or Metastatic Pancreas Cancer Phase 2
Completed NCT00196105 - Malignant Obstruction ZILVER Against Routine Therapy (MOZART I) N/A