Phase II and Pharmacological Study with Wee-1 Inhibitor AZD1775 Combined with Carboplatin in Patients with p53 Mutated Epithelial Ovarian Cancer that Show Early Relapse (< 3 months) or Progression during Standard First Line Treatment with Carboplatin – Paclitaxel Combination Therapy. With an additional safety and preliminary anti-tumor activity cohort of Wee-1 inhibitor AZD1775 Combined with Carboplatin in Patients with p53 Mutated Epithelial Ovarian Cancer, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), cervical, and endometrial cancer that Show Early Relapse (<6 months) or Progression during Standard First Treatment with cisplatin or carboplatin containing therapy. - M10MKO

etherlands Cancer Institute (NKI)0 个研究点目标入组 224 人开始时间: 2010年3月3日最近更新: 2019年6月30日

试验速览

暂无简介。

•1. p53 mutated (determined by IHC and later by sequencing) epithelial ovarian cancer
•2. measurable disease on CT scan
•3. patients previously received standard 1st line platinum therapy (combined with paclitaxel) for epithelial ovarian cancer, and showed recurrence on or within 3 months of this treatment
•4. age > 18 years
•5. WHO performance status lower or equal to 1
•1. histological or cytological proof of advanced epithelial ovarian cancer, NSCLC, SCLC, cervical and endometrial cancer (with proven p53 mutation).
•2. previously treated with (standard) (1st) line platinum-based therapy (combined with paclitaxel in case of ovarian cancer ), and showed recurrence on or within 6 months after the end of this treatment.
•3. Patients are allowed to have received second line non-platinum containing therapy after recurrence on 1st line treatment. No more than 2 lines of pre-treatment with cytotoxic chemotherapy are allowed.
•4. Eligible patients will have p53 mutation determined by sequencing of exons 2-10.
•5. Able and willing to undergo a tumor biopsy (if p53 status is already known, tumor biopsy is still mandatory).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 24

•1. symptomatic cerebral or leptomeningeal metastases
•2. current participation or previous participation in a study with an investigational compound, or chemo- and/or radiotherapy within 28 days of receiving first dose of study medication
•3. 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.
•Additional exclusion criteria for safety and activity cohort:
•1. More than 2 lines pre-treatment with cytotoxic chemotherapy are not allowed. Only the first line will be carboplatin or cisplatin containing.

发起方

etherlands Cancer Institute (NKI)