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Report for Clinical Trial NCT02989857

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation

Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of orally administered AG-120. Subjects, all personnel involved in the evaluation of subjects' response to treatment (e.g., Investigators, study coordinators, study pharmacists), and designated Sponsor team members will be blinded to study treatment. Subjects are required to have a histologically-confirmed diagnosis of IDH1 gene-mutated cholangiocarcinoma that is not eligible for curative resection, transplantation, or ablative therapies prior to enrollment.IDH1 mutation testing will be performed at participating investigative sites. Subjects must have progression of disease and have received at least 1 but not more than 2 prior treatment regimens for advanced disease (nonresectable or metastatic). All subjects must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy regimen.

NCT02989857 Advanced Cholangiocarcinoma Metastatic Cholangiocarcinoma
MeSH:Cholangiocarcinoma
HPO:Cholangiocarcinoma

2 Interventions

Name: AG-120

Type: Drug
Group Labels: 1

AG-120 experimental study drug

Name: AG-120 matched placebo

Type: Drug
Group Labels: 1

AG-120 matched placebo


Primary Outcomes

Measure: Progression Free Survival (PFS)

Time: Up to 26 weeks, on average

Secondary Outcomes

Measure: Adverse Event (AE) and Serious Adverse Event (SAE) analysis

Time: Up to 26 weeks, on average

Measure: Overall Survival (OS)

Time: Up to 52 weeks, on average

Measure: Overall Response Rate (ORR)

Time: Up to 26 weeks, on average

Description: Method of assessment will be questionnaires. Questionnaire: EORTC QLQ-C30

Measure: Quality of Life (QOL)

Time: Up to 52 weeks, on average

Description: Method of assessment will be questionnaires. Questionnaire: EORTC QLQ-Bil21

Measure: Quality of Life (QOL)

Time: Up to 52 weeks, on average

Description: Method of assessment will be questionnaires. Questionnaire: PGI-C/PGI-S

Measure: Quality of Life (QOL)

Time: Up to 52 weeks, on average

Description: Method of assessment will be questionnaires. Questionnaire: EuroQOL EQ-5D-5L

Measure: Health Economic Outcomes

Time: Up to 26 weeks, on average

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 R132C

3. Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available) based on central laboratory testing (R132C/L/G/H/S mutation variants tested). --- R132C ---



HPO Nodes


HPO: