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A Dose Escalation Study of Adavosertib(MK1775) in Combination With 5-FU or 5-FU/CDDP in Patients With Advanced Solid Tumor (1775-005

NCT01047007 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-09-21

Study results available
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Summary

The study evaluates safety of adavosertib in monotherapy, and in combination with 5-Fluorouracil (5-FU) alone or with 5-FU/cis-diamminedichloroplatinum (CDDP) in Japanese participants with solid tumor. The primary hypothesis is that adavosertib is safe and tolerable in participants with locally advanced or metastatic solid tumors.

Conditions

Interventions

DRUG

adavosertib 20 mg

Adavosertib 20 mg capsule administered orally on days 1-5 of a 21 day cycle.

DRUG

5-FU 1000 mg/m^2/day

5-FU 1000 mg/m\^2/day administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle

DRUG

CDDP

CDDP 60 mg/m\^2 to 100 mg/m\^2 administered as an IV infusion on Day 1.

DRUG

adavosertib 65 mg

Adavosertib 65 mg capsule administered orally on days 1-5 of a 21 day cycle.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-18
Primary Completion
2011-06-15
Completion
2011-06-15

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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 NCT01047007 on ClinicalTrials.gov