Afatinib and Gemcitabine/Nab-paclitaxel in Metastatic Pancreatic Cancer
NCT02975141 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2018-08-13
Summary
This study sets out to determine the maximum tolerated dose (MTD) of afatinib in combination with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. The identified MTD will serve as recommended phase II dose (RP2D).
Conditions
Interventions
- DRUG
-
Afatinib 30Mg Tab
Study Drug
- DRUG
-
Afatinib 40Mg Tab
Study Drug
- DRUG
-
Gemzar
Chemotherapy Backbone
- DRUG
-
Chemotherapy Backbone
Sponsors & Collaborators
-
Technical University of Munich
collaborator OTHER -
University of Cologne
collaborator OTHER -
PD Dr. med. Volker Heinemann
lead OTHER
Principal Investigators
-
Volker Heinemann, Professor · University of Munich - Klinikum Großhadern
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-30
- Primary Completion
- 2018-12-31
- Completion
- 2019-06-30
Countries
- Germany
Study Locations
More Related Trials
-
Gemcitabine With Abraxane and Other Investigational Therapies in Neoadjuvant Treatment of Pancreatic Adenocarcinoma
NCT01470417 ·Status: COMPLETED ·Phase: PHASE2
-
Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer
NCT00320749 ·Status: COMPLETED ·Phase: PHASE1
-
Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma
NCT02172976 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer
NCT02570711 ·Status: TERMINATED ·Phase: PHASE2
-
Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer
NCT01851174 ·Status: TERMINATED ·Phase: PHASE2
-
Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma
NCT02879318 ·Status: COMPLETED ·Phase: PHASE2
-
Gemcitabine Alone or in Combination With Other Chemotherapy Drugs in Treating Patients With Metastatic Cancer of the Pancreas
NCT00012220 ·Status: COMPLETED ·Phase: PHASE2
-
Gemcitabine, Cisplatin, Epirubicin, and Capecitabine in Treating Patients With Stage I-II Resectable Pancreatic Cancer
NCT01150630 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer
NCT05673811 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma
NCT05624918 ·Status: RECRUITING ·Phase: PHASE2
-
Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Pancreatic Cancer
NCT00564720 ·Status: TERMINATED ·Phase: PHASE2
-
Study of Gemcitabine and Abraxane to Treat Potentially Operable Pancreatic Cancer
NCT01298011 ·Status: COMPLETED ·Phase: PHASE2
-
Genes as Predictors of Response to Gemcitabine, Docetaxel, and Capecitabine (GTX) in Metastatic or Unresectable Pancreatic Cancer.
NCT00159471 ·Status: TERMINATED ·Phase: NA
-
A Study of ABTL0812 in Pancreatic Cancer
NCT03417921 ·Status: SUSPENDED ·Phase: PHASE1/PHASE2
-
Trial to Investigate Intensified Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer
NCT02125136 ·Status: COMPLETED ·Phase: PHASE2
-
AVN944 in Combination With Gemcitabine for the Treatment of Pancreatic Cancer
NCT00493441 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy Study of Gemcitabine-erlotinib Versus Gemcitabine-erlotinib-capecitabine in Patients With Metastatic Pancreatic Cancer
NCT01303029 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Gemcitabine, Nab-paclitaxel, and Ficlatuzumab (AV-299) in Patients With Advanced Pancreatic Cancer
NCT03316599 ·Status: COMPLETED ·Phase: PHASE1
-
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
NCT00003810 ·Status: COMPLETED ·Phase: PHASE2
-
Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer
NCT02451553 ·Status: COMPLETED ·Phase: PHASE1
-
Gemcitabine Versus Reduced-dose Combination Chemotherapy in Fragile Patients with Non-resectable Pancreatic Cancer
NCT05841420 ·Status: RECRUITING ·Phase: PHASE2
-
First-line Therapy in Metastatic PDAC
NCT03487016 ·Status: UNKNOWN ·Phase: PHASE2
-
AXP107-11 in Combination With Standard Gemcitabine (Gemzar® ) Therapy for Treatment in Patients With Pancreatic Cancer
NCT01182246 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Safety and Efficacy Study of Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Metastatic Pancreatic Cancer
NCT02017015 ·Status: COMPLETED ·Phase: PHASE2
-
Study Of PF-03084014 In Combination With Gemcitabine And Nab-Paclitaxel In Patients With Metastatic Pancreatic Adenocarcinoma Not Previously Treated With Anticancer Therapies
NCT02109445 ·Status: TERMINATED ·Phase: PHASE2