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.
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
Drug | Synonyms | Arms |
---|
Crenolanib | | Crenolanib combined with ramucirumab/paclitaxel |
Ramucirumab | | Crenolanib combined with ramucirumab/paclitaxel |
Paclitaxel | | Crenolanib 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
Name | Type | Description | Interventions |
---|
Crenolanib combined with ramucirumab/paclitaxel | Experimental | | - 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: | Completed |
Lead Sponsor: | Arog Pharmaceuticals, Inc. |
Last Updated
July 20, 2020