Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma
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ClinicalTrials.gov Identifier: NCT03193918 |
Recruitment Status :
Completed
First Posted : June 21, 2017
Last Update Posted : July 20, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophagogastric Adenocarcinoma | Drug: Crenolanib Drug: Ramucirumab Drug: Paclitaxel | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/Ib Study of Crenolanib With Ramucirumab and Paclitaxel as Second Line Therapy for Advanced Esophagogastric Adenocarcinoma |
Actual Study Start Date : | April 14, 2017 |
Actual Primary Completion Date : | July 15, 2020 |
Actual Study Completion Date : | July 15, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Crenolanib combined with ramucirumab/paclitaxel |
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 |
- 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 ]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.
- Response rate (RR) of the combination in patients will be radiographically evaluated until progressive disease (PD), intolerable toxicity, withdrawal of consent, physician's decision, death or the completion of 6 cycles. adenocarcinoma patients [ Time Frame: Bi-monthly for up to 6 months. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193918
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Geoffrey Ku, MD | Memorial Sloan Kettering Cancer Center |
Responsible Party: | Arog Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT03193918 |
Other Study ID Numbers: |
ARO-017 |
First Posted: | June 21, 2017 Key Record Dates |
Last Update Posted: | July 20, 2020 |
Last Verified: | July 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Paclitaxel Ramucirumab |
Crenolanib Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |