study with AZD1775 combined with carboplatin in patients with ovarian cancer. An extra group with additional safety and anti-tumor activity in patients with Ovarian Cancer, lung cancer, cervical and endometrial cancer.

Phase 1

• Conditions: p53 mutated epithelial ovarian cancer (after first line standard therapy), non-small cell lung cancer, small cell lung cancer, cervical and endometrial cancer; MedDRA version: 20.0 Level: PT Classification code 10014733 Term: Endometrial cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10055094 Term: Cervix cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-019106-16-NL
• Lead Sponsor: etherlands Cancer Institute (NKI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 224

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified