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Open-label Phase 1b Study of ARQ 092 in Combination With Anastrozole

NCT02476955 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2020-09-30

No results posted yet for this study

Summary

An Open-label Phase 1b Study of ARQ 092 in Combination with other Antineoplastic Agents in Subjects with Selected Solid Tumors

Conditions

Interventions

DRUG

ARQ 092 + carboplatin + paclitaxel (Closed)

Subjects will receive ARQ 092 orally at dose levels specified for their respective dose cohorts plus carboplatin (AUC6, intravenously, Day 1) plus paclitaxel (175 mg/m2, intravenously, Day 1) on a 21-day schedule.

DRUG

ARQ 092 + paclitaxel (Closed)

ARQ 092 will be administered orally at 200 mg twice a day (BID) weekly (Cohort 1P) of a 28-day cycle in combination with an intravenous (IV) infusion of paclitaxel (80 mg/m2). ARQ 092 will be administered once a week on Day 1, Day 8, Day 15, and Day 22 of each 28-day cycle; paclitaxel will be administered once a week on Day 1, Day 8, and Day 15 for three consecutive weeks followed by one week off of each 28-day cycle.

DRUG

ARQ 092 + anastrozole

ARQ 092 will be administered orally at 150 mg QD, 5 days on/9 days of a 28 day cycle in combination with anastrozole which will be administered orally at 1 mg QD continuously.

Sponsors & Collaborators

  • ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-09
Primary Completion
2019-05-07
Completion
2019-05-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02476955 on ClinicalTrials.gov