Clinical trialPhase 1Terminated
Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)
Phase I Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
- Outcome
- Stopped earlyUnable to proceed due to Neulasta difficulties and other complications. (Other)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 11 September 2019
- Expected end
- 4 October 2023
- Enrollment
- 14 participants
- Sites
- 1
- Primary outcomes
- Frequency of Dose Limiting Toxicities (DLTs)
- Sponsor
- Other
- Results posted
- No
- Last update
- 5 January 2024
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Brief summary public domain (ClinicalTrials.gov)
The purpose of this study is to determine the recommended phase 2 dose (RP2D) of the combination of lonsurf, gemcitabine and nab-paclitaxel in Pancreatic ductal adenocarcinoma (PDAC)
Detailed description public domain (ClinicalTrials.gov)
This is a single-institution, prospective, phase I dose escalation trial of lonsurf combined with gemcitabine and nab-paclitaxel using the 3+3 design. This study will enroll 18 patients over 12-15 months. Primary Objective To determine the recommended phase 2 dose (RP2D) of the combination of lonsurf, gemcitabine and nab-paclitaxel Secondary Objectives 1. Examine safety and toxicity of the combination 2. Estimate response rate to the combination 3. Estimate median overall survival (mOS) of the treated population 4. Estimate median progression free survival (mPFS) of the treated population 5. Estimate disease control rate (DCR) at 8 weeks 6. Evaluate quality of life while receiving the combination therapy