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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03193918
Other study ID # ARO-017
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 14, 2017
Est. completion date July 15, 2020

Study information

Verified date July 2020
Source Arog Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 15, 2020
Est. primary completion date July 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Crenolanib
Crenolanib continuously on Days 1-28 at 1 of 3 BID doses - 60 mg, 80 mg or 100 mg
Ramucirumab
Ramucirumab IV 8 mg/kg on Days 1 and 15 q28 days
Paclitaxel
Paclitaxel IV 80 mg/m2 on Days 1, 8 and 15 q28 days

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Arog Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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. 5 weeks
Primary 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 Bi-monthly for up to 6 months.
See also
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