Trials / Completed
CompletedNCT03193918
Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma
Phase I/Ib Study of Crenolanib With Ramucirumab and Paclitaxel as Second Line Therapy for Advanced Esophagogastric Adenocarcinoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Arog Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-04-14
- Primary completion
- 2020-07-15
- Completion
- 2020-07-15
- First posted
- 2017-06-21
- Last updated
- 2020-07-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03193918. Inclusion in this directory is not an endorsement.