Phase Ib Study AZD1775 in Combination With Carboplatin and Paclitaxel in Adult Asian Patients With Solid Tumours
Condition: Advanced Solid Tumours
MeSH terms: Neoplasms
Intervention: AZD1775; Paclitaxel; carboplatin
Intervention description: AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small-molecule inhibitor of the WEE1 kinase that sensitizes tumour cells to cytotoxic agents and is being developed for the treatment of advanced solid tumours and p53 pathway deficient malignancies. Gemcitabine is a nucleoside analog used as chemotherapy.; Paclitaxel is a mitotic inhibitor used in cancer chemotherapy ; it and docetaxel represent the taxane family of drugs.; Carboplatin is a chemotherapy drug used against some forms of cancer (mainly ovarian carcinoma, lung, head and neck cancers as well as endometrial, esophageal, bladder, breast and cervical; central nervous system or germ cell tumors; osteogenic sarcoma, and as preparation for a stem cell or bone marrow transplant.).
Intervention MeSH terms: Paclitaxel; Carboplatin; Adavosertib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      This is a phase Ib, open-label, multicentre study of AZD1775 administered orally in
      monotherapy and in combination with carboplatin and paclitaxel to Asian patients with
      advanced solid tumours.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological confirmation of a locally advanced or metastatic solid
             tumour, excluding lymphoma, that failed to respond to standard therapy, progressed
             despite standard therapy, or for which standard therapy does not exist.

          -  At least 1 measureable lesion that can be accurately assessed at baseline by
             computerised tomography (CT) or magnetic resonance imaging (MRI) for solid tumours
             assessed using RECIST v1.1.

          -  World Health Organisation performance status 0 to 1 with no deterioration over the
             previous 2 weeks and a minimum life expectancy of ≥12 weeks.

        Exclusion Criteria:

          -  Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a
             previous treatment regimen or clinical study within 14 days (if investigational agent
             does not have well characterised PK profile) or 5 × half-lives of the first dose of
             study treatment

          -  Patient has had prescription or non-prescription drugs or other products (ie,
             grapefruit juice) known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with
             a narrow therapeutic index, or to be moderate to strong inhibitors or inducers of
             CYP3A4, which cannot be discontinued 2 weeks before Day 1 of dosing and withheld
             throughout the study until 2 weeks after the last dose of study drug.
             Co-administration of aprepitant during this study is prohibited.

          -  AZD1775 is an inhibitor of breast cancer resistance protein (BCRP). The use of statins
             including Atorvastatin which are substrates for BCRP are therefore prohibited and
             patients should be moved on to non-BCRP alternatives.