Clinical Trials /

Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma

NCT03193918

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Adenocarcinoma
  • Gastric Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma
  • Official Title: Phase I/Ib Study of Crenolanib With Ramucirumab and Paclitaxel as Second Line Therapy for Advanced Esophagogastric Adenocarcinoma

Clinical Trial IDs

  • ORG STUDY ID: ARO-017
  • NCT ID: NCT03193918

Conditions

  • Esophagogastric Adenocarcinoma

Interventions

DrugSynonymsArms
CrenolanibCrenolanib combined with ramucirumab/paclitaxel
RamucirumabCrenolanib combined with ramucirumab/paclitaxel
PaclitaxelCrenolanib combined with ramucirumab/paclitaxel

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Crenolanib combined with ramucirumab/paclitaxelExperimental
  • Crenolanib
  • Ramucirumab
  • Paclitaxel

Eligibility Criteria

        Inclusion Criteria:

          -  Pathologically confirmed adenocarcinoma of the esophagus, GEJ or stomach.

          -  Stage IV disease or locally advanced/unresectable tumors

          -  Prior progression on only 1 line of chemotherapy in the advanced/metastatic setting
             containing a fluoropyrimidine and/or platinum compound

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

        Exclusion Criteria:

          -  Prior treatment with a taxane is not permitted in the dose-expansion phase. Patients
             in the dose escalation component may have received a taxane in the peri-operative
             setting, provided they developed disease recurrence >6 months after the completion of
             this therapy

          -  Known pre-existing liver disease (e.g. cirrhosis, chronic hepatitis B or C,
             nonalcoholic steatohepatitis, sclerosing cholangitis)

          -  Patients with any clinically apparent ascites or who have undergone a paracentesis
             within 7 days of enrollment

          -  Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm
             Hg on repeated measurement) despite optimal medical management

          -  Active or clinically significant cardiac disease

          -  Patients with arterial thrombotic events, such as cerebrovascular accident or
             myocardial infarction, within 6 months of enrollment
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:MTD of oral continuous dosing of crenolanib (3 different doses) plus ramucirumab/paclitaxel in patients defined as the highest dose level in which <2 of 6 patients develop a DLT. The DLT is based on the 1st cycle adverse events.
Time Frame:5 weeks
Safety Issue:
Description:The DLT is based on the first cycle (35 days) adverse events. If at least 2 of 3 or 2 of up to 6 patients experience a DLT at the starting dose level, then the study will be paused and the starting dose will be re-assessed. The MTD is defined as the highest dose level in which <2 of 6 patients develop a DLT. This will constitute the first part of the study which will enroll a maximum of 18 patients.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Arog Pharmaceuticals, Inc.

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