Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)
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|ClinicalTrials.gov Identifier: NCT04046887|
Recruitment Status : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : August 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Pancreatic Ductal Adenocarcinoma||Drug: Lonsurf Drug: Gemcitabine Drug: Nab-Paclitaxel||Phase 1|
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
- Examine safety and toxicity of the combination
- Estimate response rate to the combination
- Estimate median overall survival (mOS) of the treated population
- Estimate median progression free survival (mPFS) of the treated population
- Estimate disease control rate (DCR) at 8 weeks
- Evaluate quality of life while receiving the combination therapy
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||
Initially 3 patients will be enrolled to the starting cohort. If 1 of 3 patients experience a dose-limiting toxicity (DLT) in the first cycle, then an additional 3 evaluable patients will be accrued to that dose level. Dose reductions are not permitted during cycle 1. If 2 or more patients in a cohort experience a DLT, then the previous dose will be considered the recommended phase 2 dose (PR2D) and dose escalation will terminate. Dose escalation will proceed according to the scheme above only after all patients (3 or 6 evaluable patients, depending on the incidence of DLT) have been followed for at least 1 full cycle.
Once dose escalation has been completed, if only 2 dose levels were used to determine the RP2D and depending on how many patients were replaced, additional patients will be enrolled at the RP2D in order to obtain data for 18 patients total.
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)|
|Estimated Study Start Date :||August 2019|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2020|
|Experimental: Combination of lonsurf + gemcitabine + nab-paclitaxel||
Lonsurf will be administered orally twice a day on days 2-6 and 16-20 of every 28-day cycle at a dose of 25 mg/m2, 20 mg/m2 or 30 mg/m2 depending on cohort assignment.
Gemcitabine will be intravenously administered on Days 1 and 15 of every 28-day cycle at a dose of 800 mg/m2, 600 mg/m2 or 1000 mg/m2 depending on cohort assignment.
Nab-Paclitaxel will be intravenously administered on Days 1 and 15 of every 28-day cycle at a dose of 100 mg/m2, 75 mg/m2 or 125 mg/m2 depending on cohort assignment.
- Frequency of Dose Limiting Toxicities (DLTs) [ Time Frame: 28 days (Cycle 1) ]Number of DLTs observed
- Frequency of adverse events in the safety evaluable population [ Time Frame: from start of treatment until 30 days after treatment discontinuation (i.e up to 2 years) ]safety and toxicity data will be assessed using NCI CTCAE v5.0
- Response rate to the combination of lonsurf, gemcitabine, and nab-paclitaxel in the efficacy evaluable population [ Time Frame: from start of treatment until treatment discontinuation (i.e. up to 2 years) ]Using RECIST 1.1
- Median Overall Survival (mOS) of the treated population [ Time Frame: from start of treatment until death or last known follow up (i.e up to 2 years) ]
- Median Progression-free Survival (mPFS) of the treated population [ Time Frame: from start of treatment until disease progression or last follow up (i.e. up to 2 years) ]
- Disease control rate (DCR) [ Time Frame: 8 weeks ]Disease control rate (DCR) as defined by (complete response + partial response + stable disease)
- European Organization for Research and Treatment of Cancer quality of life questionnaire [ Time Frame: Day 1 of each cycle(each cycle is 28 days),from start of treatment until disease progression or discontinuation of treatment (i.e. up to 2 years) ]Scale scores were calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046887
|Contact: Janet Flynn, RNemail@example.com|
|Contact: Patrick J Loehrer, MDfirstname.lastname@example.org|
|United States, Indiana|
|Indiana University Melvin & Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Patrick J Loehrer, MD||Indiana University|