Study of Adavosertib(AZD1775) in Japanese Patients With Advanced Solid Tumours
Condition: Advanced Solid Tumours
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open-label study to assess the safety, tolerability, pharmacokinetics(PK)
      and anti-tumour activity of adavosertib in Japanese patients with advanced solid tumours.
      This study consists of 2 parts, monotherapy (part A) and chemotherapy combination (part B).
      At least 3, or up to 6, evaluable Japanese patients with advanced solid tumours will be
      enrolled in each cohort to confirm the tolerability.
    

Detailed description: 
      Objectives:

      Primary objective:

      Part A:

      To assess the safety and tolerability, describe any dose-limiting toxicity (DLT) for
      adavosertib

      Secondary objective:

      To determine the PK profile of adavosertib To describe adavosertib's preliminary anti-tumour
      activity using the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

      Part B:

      To assess the safety and tolerability, describe any dose-limiting toxicity (DLT) for
      adavosertib in combination with gemcitabine

      Secondary objective:

      To determine the PK profile of adavosertib plus gemcitabine To describe preliminary
      anti-tumour activity of adavosertib in combination with gemcitabine using the Response
      Evaluation Criteria in Solid Tumours (RECIST) v1.1 To assess the drug interaction between
      adavosertib and gemcitabine

      Overall design:

      This is a phase I, open-label study to assess the safety, tolerability, PK and anti-tumour
      activity of adavosertib in Japanese patients with advanced solid tumours. This study consists
      of 2 parts, monotherapy (part A) and chemotherapy combination (part B). At least 3, or up to
      6, evaluable Japanese patients with advanced solid tumours will be enrolled in each cohort.
      The total number of subjects will depend upon the available data in each cohort and the
      Safety Review Committee (SRC)'s decision.

      Number of Subjects:

      At least 3, or up to 6, evaluable Japanese patients with advanced solid tumours will be
      enrolled in each cohort.

      Treatments and treatment duration:

      Subjects in each part will receive the study treatments as described below:

      Part A: Adavosertib by mouth (PO) once daily (QD) for 5 days ON and 2 days OFF for week 1 and
      2 of a 21 days cycle.

      Part B: Adavosertib PO will be taken QD on Days 2, 3, 9, 10, 16, and 17. Gemcitabine will be
      administered by intravenous infusion according to institutional standards on Days 1, 8, and
      15 of each 28-day cycle.

      Subjects will be allowed to continue adavosertib until disease progression, intolerable
      toxicity, or discontinuation criteria have been met.
    

Intervention name(s): Adavosertib (AZD1775)
Intervention type(s): Drug
Intervention description(s): Adavosertib taken orally
Intervention MeSH terms: Adavosertib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other