Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-14

Study Completion Date

2020-07-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Esophagogastric Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crenolanib combined with ramucirumab/paclitaxel

Group Type EXPERIMENTAL

Crenolanib

Intervention Type DRUG

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

Ramucirumab

Intervention Type DRUG

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

Paclitaxel

Intervention Type DRUG

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

Interventions

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Crenolanib

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

Intervention Type DRUG

Ramucirumab

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

Intervention Type DRUG

Paclitaxel

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No