Regorafenib in Combination With Paclitaxel in Advanced Oesophagogastric Carcinoma (REPEAT)
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|ClinicalTrials.gov Identifier: NCT02406170|
Recruitment Status : Completed
First Posted : April 2, 2015
Last Update Posted : October 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Neoplasms Stomach Neoplasms Neoplasm Metastasis||Drug: Regorafenib Drug: Paclitaxel||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The REPEAT Trial: Regorafenib in Combination With Paclitaxel in Advanced Oesophagogastric Carcinoma, a Phase 1b Study|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||October 2019|
|Actual Study Completion Date :||October 2019|
Regorafenib tolerability will be tested in a dose escalation scheme with a cytotoxic backbone of paclitaxel 80mg/m2.
The dose of regorafenib will be escalated in fixed increments to establish the maximum tolerated dose (MTD) from day 1-21 against a cytotoxic backbone of paclitaxel 80mg/m2 on days 1, 8 and 15 of a 28 day cycle
Other Name: dose escalation scheme
Paclitaxel will be administered in combination with regorafenib to serve as a cytotoxic backbone, it will be given in a dose of 80mg/m2 on days 1,8 and 15 of a 28 day cycle.
- Toxicity graded according to NCI Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: 4 weeks ]graded according to NCI Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE).
- Paclitaxel concentration in tumor biopsy [ Time Frame: 2 year ]
- Composite Paclitaxel pharmacokinetics [ Time Frame: 2 year ]Area under the plasma concentration versus time curve (AUC), Peak plasma concentration (Cmax)
- Expression of regorafenib targets in tumor biopsy samples [ Time Frame: 2 year ]
- Progression free survival [ Time Frame: 2 years ]
- Overall survival [ Time Frame: 2 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406170
|Academic Medical Center, Medical Oncology|
|Amsterdam, Netherlands, 1100 DD|
|Principal Investigator:||Hanneke WM van Laarhoven, MD,PHD||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|