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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02575508
Other study ID # I 265214
Secondary ID NCI-2015-01597I
Status Withdrawn
Phase Phase 1/Phase 2
First received October 6, 2015
Last updated May 19, 2016

Study information

Verified date May 2016
Source Roswell Park Cancer Institute
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This phase Ib/II trial studies the side effects and best dose of pan fibroblast growth factor receptor (FGFR) kinase inhibitor BGJ398 when given together with fluorouracil, irinotecan hydrochloride and oxaliplatin (combination chemotherapy) in treating patients with untreated pancreatic cancer that has spread to another place in the body. Pan FGFR kinase inhibitor BGJ398 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, irinotecan hydrochloride and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pan FGFR kinase inhibitor BGJ398 together with fluorouracil, irinotecan hydrochloride and oxaliplatin may be a better treatment for pancreatic cancer.


Description:

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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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Locations

Country Name City State
United States Roswell Park Cancer Institute Buffalo New York

Sponsors (2)

Lead Sponsor Collaborator
Roswell Park Cancer Institute National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of dose-limiting toxicity (DLT) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase Ib) Up to 28 days Yes
Primary Maximum tolerated dose (MTD) and recommended phase II dose of BGJ398 in combination with mFOLFIRINOX, defined as the dose with a probability of DLT of 0.30 graded according to the NCI CTCAE version 4.0 (Phase Ib) The MTD will be estimated using isotonic regression (cumulative cohort design). 28 days Yes
Primary Overall survival (Phase II) The overall survival will be summarized using Kaplan-Meier methods, from which an estimate of the 6-month survival rate and corresponding standard error will be obtained using the methods proposed by Breslow and Day. Time from the start of the study treatment until death, last follow-up or drop-out, assessed at 6 months No
Secondary Changes in CA19-9 expression levels (Phase II) The CA19-9 expression will be reported by time as mean, median, standard deviation, and percentiles. Changes in expression will be evaluated using the paired t-test or Wilcoxon signed rank test, as appropriate. Baseline to 2 years No
Secondary Incidence of adverse events graded according to the NCI CTCAE version 4.0 The frequency of toxicities will be tabulated by grade across all dose levels and cycles. The frequency of toxicities will also be tabulated for the dose estimated to be the MTD and RP2D in phase Ib. Up to 28 days after completion of study treatment Yes
Secondary Objective tumor response (Phase II) The objective tumor responses will be reported as frequencies and relative frequencies, with the response rates estimated with Clopper-Pearson 95% confidence intervals. Up to 2 years No
Secondary Progression free survival (Phase II) The progression free survival will be summarized using standard Kaplan-Meier methods, with estimates of median survival and given survival rates (i.e., 1 year) will be obtained with 95% confidence intervals. Up to 2 years No
Secondary Potential associations between response rate and tumor biomarkers (Phase II) Will be evaluated using logistic regression models and associated exact methods. Up to 2 years No
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