Recent Updates
Recently added Catalysts

ARRY-614, p38/Tie2 inhibitor

Phase 1

Myelodysplastic Syndromes | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 9, 2020

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment116

FDA Designations

No designations recorded

Clinical trial landscape

ARRY-614, p38/Tie2 inhibitor · 2 trials · 1 indication

Phase 1 2
NCT01496495A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic SyndromesMyelodysplastic Syndromes
COMPLETED71 Analytics
NCT00916227A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic SyndromeMyelodysplastic Syndromes
COMPLETED45 Analytics
PHASE1COMPLETED
A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes
Myelodysplastic SyndromesUnlock trial analytics
PHASE1COMPLETED
A Study of ARRY-614 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndrome
Myelodysplastic SyndromesUnlock trial analytics

Study Endpoints

Primary Endpoints

Establish the maximum tolerated dose (MTD) of study drug.
Part 1, 9 months
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Part 1, 9 months; Part 2, 9 months
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
Part 1, 9 months; Part 2, 9 months
Characterize the safety profile of the study drug, in either the fasted or fed state, in terms of adverse events, clinical laboratory tests and electrocardiograms.
Part 1, one year; Part 2, one year
Establish the maximum tolerated dose (MTD) of the study drug.
Part 1, one year
Characterize the pharmacokinetics of the study drug and a metabolite under either fasted or fed conditions.
Part 1, one year; Part 2, one year

Secondary Endpoints

Assess the efficacy of the study drug in terms of response, time to response, duration of response, overall survival, hematologic improvement and platelet transfusion independence/reduction.
Part 1, 9 months; Part 2, 9 months
Assess the efficacy of study drug in terms of response, duration of response and hematologic improvement.
Part 1, one year; Part 2, one year
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ARRY-614EXPERIMENTAL -

Interventions

NameTypeDescription
ARRY-614, p38/Tie2 inhibitor; oralDRUGPart 1: multiple dose, escalating; Part 2: multiple dose, single schedule
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria (Part 1 and Part 2): * Diagnosis of MDS by bone marrow biopsy. * International Prognostic Scoring System (IPSS) score of low or intermediate-1 risk MDS. * May have received prior therapy for MDS. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about ARRY-614, p38/Tie2 inhibitor

What is ARRY-614 used for?

ARRY-614 is an investigational small molecule being studied for the treatment of Myelodysplastic Syndromes (MDS), specifically in patients with low or intermediate-1 risk disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does ARRY-614 target?

ARRY-614 is a p38/Tie2 inhibitor, meaning it targets the p38 mitogen-activated protein kinase and the Tie2 receptor tyrosine kinase. By inhibiting these targets, the drug is designed to modulate signaling pathways involved in the development and progression of Myelodysplastic Syndromes.

Who is developing ARRY-614?

ARRY-614 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical trials for the treatment of Myelodysplastic Syndromes.

What phase is ARRY-614 in?

ARRY-614 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied in patients with low or intermediate-1 risk Myelodysplastic Syndromes.

What clinical trials is ARRY-614 in?

ARRY-614 has been studied in two completed Phase 1 clinical trials: NCT00916227, which enrolled 45 patients, and NCT01496495, which enrolled 71 patients. Both trials were conducted in the United States and involved patients with low or intermediate-1 risk Myelodysplastic Syndromes.

Is ARRY-614 the same as p38/Tie2 inhibitor?

ARRY-614 is the drug name, and p38/Tie2 inhibitor describes its mechanism of action. The drug is a small molecule that inhibits both p38 and Tie2, and it is being developed by Pfizer for the treatment of Myelodysplastic Syndromes.