MedTrace Logo

Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma

NCT03193918 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-07-20

No results posted yet for this study

Summary

This is a single-arm phase I/Ib study of crenolanib combined with ramucirumab/paclitaxel as second line therapy for patients with advanced/metastatic adenocarcinoma of the esophagus, GEJ or stomach. Patients will be enrolled in two phases; dose escalation phase and dose expansion phase.

Conditions

  • Esophagogastric Adenocarcinoma

Interventions

DRUG

Crenolanib

Crenolanib continuously on Days 1-28 at 1 of 3 BID doses - 60 mg, 80 mg or 100 mg

DRUG

Ramucirumab

Ramucirumab IV 8 mg/kg on Days 1 and 15 q28 days

DRUG

Paclitaxel

Paclitaxel IV 80 mg/m2 on Days 1, 8 and 15 q28 days

Sponsors & Collaborators

  • Arog Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Geoffrey Ku, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-14
Primary Completion
2020-07-15
Completion
2020-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03193918 on ClinicalTrials.gov