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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

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Terminated
Phase 1

Conditions

Solid Tumors

Treatments

Drug: adavosertib 65 mg
Drug: CDDP
Drug: 5-FU 1000 mg/m^2/day
Drug: adavosertib 20 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01047007
MK1775-005 (Other Identifier)
1775-005

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

11 participants in 4 patient groups

Part 1: adavosertib 65 mg BID
Experimental group
Description:
Participants received 65 mg of adavosertib administered orally twice a day (BID) on Days 1-5 of a 21-day cycle.
Treatment:
Drug: adavosertib 65 mg
Part 2 A1: adavosertib 20 mg BID+5-FU 1000 mg
Experimental group
Description:
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.
Treatment:
Drug: adavosertib 20 mg
Drug: 5-FU 1000 mg/m^2/day
Part 2 A2: adavosertib 20 mg QD+5-FU 1000 mg
Experimental group
Description:
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.
Treatment:
Drug: adavosertib 20 mg
Drug: 5-FU 1000 mg/m^2/day
Parts 2B +3: adavosertib+5-FU+CDDP
Experimental group
Description:
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.
Treatment:
Drug: adavosertib 20 mg
Drug: 5-FU 1000 mg/m^2/day
Drug: adavosertib 65 mg
Drug: CDDP

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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