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Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03193918
Recruitment Status : Recruiting
First Posted : June 21, 2017
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Arog Pharmaceuticals, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Esophagogastric Adenocarcinoma Drug: Crenolanib Drug: Ramucirumab Drug: Paclitaxel Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 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
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Hyuntae Yoo, PhD 2145930527 hyoo@davacro.com

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Geoffrey Ku, MD       kug@mskcc.org   
Sponsors and Collaborators
Arog Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Geoffrey Ku, MD Memorial Sloan Kettering Cancer Center
More Information
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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 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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