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

NCT ID: NCT01047007

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-18
• Study Completion Date: 2011-06-15

Brief 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

Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: adavosertib 65 mg BID

Participants received 65 mg of adavosertib administered orally twice a day (BID) on Days 1-5 of a 21-day cycle.

Group Type: EXPERIMENTAL

adavosertib 65 mg

Intervention Type: DRUG

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

Part 2 A1: adavosertib 20 mg BID+5-FU 1000 mg

Participants received 20 mg of adavosertib administered orally BID on Days 1-5 of a 21-day cycle and 1000 mg/m\^2/day of 5-FU administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle.

Group Type: EXPERIMENTAL

adavosertib 20 mg

Intervention Type: DRUG

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

5-FU 1000 mg/m^2/day

Intervention Type: DRUG

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

Part 2 A2: adavosertib 20 mg QD+5-FU 1000 mg

Participants received 20 mg of adavosertib administered orally once a day (QD) on Days 1-5 of a 21-day cycle and 1000 mg/m\^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle.

Group Type: EXPERIMENTAL

adavosertib 20 mg

Intervention Type: DRUG

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

5-FU 1000 mg/m^2/day

Intervention Type: DRUG

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

Parts 2B +3: adavosertib+5-FU+CDDP

Participants were to receive 20 mg or 65 mg of adavosertib administered either BID or QD on Days 1-5 of a 21-day cycle; 1000 mg/m\^2/day of 5-FU administered as an IV infusion on Days 1-4 of a 21-day cycle; and 60 mg/m\^2 to 100 mg/m\^2 of CDDP administered as an IV infusion on Day 1.

Group Type: EXPERIMENTAL

adavosertib 20 mg

Intervention Type: DRUG

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

5-FU 1000 mg/m^2/day

Intervention Type: DRUG

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

CDDP

Intervention Type: DRUG

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

adavosertib 65 mg

Intervention Type: DRUG

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

Interventions

adavosertib 20 mg

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

Intervention Type: 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

Intervention Type: DRUG

CDDP

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

Intervention Type: DRUG

adavosertib 65 mg

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

Intervention Type: DRUG

Other Intervention Names

MK-1775; Cisplatin; MK-1775

Eligibility Criteria

Inclusion Criteria

• Parts 1 and 2-A: Patient must have a histologically or cytologically confirmed locally advanced or metastatic solid tumor failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist
• Parts 2-B and 3: Patient must have a histologically or cytologically confirmed locally advanced or metastatic esophageal, head and neck, or gastric cancer, and be a candidate of 5-Fluorouracil and Cisplatin regimen defined in this study
• Patient must have performance status of 0 or 1 on the ECOG Performance Scale

Exclusion Criteria

• Patient who has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study drug or who has not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patient with a known primary central nervous system tumor
• Patient has known hypersensitivity to any of the components of the combination study therapy or its analogs
• Patient is receiving "alternative" cancer medications such as plant-derived products and their analogs with anti-tumor activity within 1 week prior to entering the study.
• Patient must not have prior radiation therapy to more than 30% of the bone marrow and must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

MK1775-005

Identifier Type: OTHER

Identifier Source: secondary_id

1775-005

Identifier Type: -

Identifier Source: org_study_id