Conditions: Solid Tumors
Keywords: Head and Neck Cancer Esophageal Cancer Gastric Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 11
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Participants received 65 mg of adavosertib administered orally twice a day (BID) on Days 1-5 of a 21-day cycle. arm 2: 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. arm 3: 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. arm 4: 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.

Interventions: intervention 1: adavosertib 20 mg intervention 2: 5-FU 1000 mg/m^2/day intervention 3: CDDP intervention 4: adavosertib 65 mg
Intervention descriptions: intervention 1: Adavosertib 20 mg capsule administered orally on days 1-5 of a 21 day cycle. intervention 2: 5-FU 1000 mg/m\^2/day administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle intervention 3: CDDP 60 mg/m\^2 to 100 mg/m\^2 administered as an IV infusion on Day 1. intervention 4: Adavosertib 65 mg capsule administered orally on days 1-5 of a 21 day cycle.

Protocol document: