Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT01164995
Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological proof of epithelial ovarian cancer, and proven p53 mutated pathway by PCR/Sequencing. IHC will also be performed. In the additional safety and efficacy cohort also inclusion of NSCLC, SCLC, cervical and endometrial cancer (only ovarian cancer cohort is pursued)
* Measurable disease on a CT-scan or elevated Cancer Antigen (CA)-125 levels that can be monitored.
* 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 (relapse within 6 months in the additional safety and efficacy cohort)
* Able and willing to voluntarily give written informed consent.
* Able and willing to undergo blood sampling for pharmacokinetics and pharmacodynamics.
* Life expectancy ≥ 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity.
* Minimal acceptable safety laboratory values:
* Absolute neutrophil count (ANC) of ≥ 1.5 x 109 /L (or 1500/m3).
* Platelet count of ≥ 100 x 109 /L (or 100,000/mm3).
* Hemoglobin ≥ 5.6 mmol/L (or 9.1 g/dl).
* Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALAT and ASAT ≤ 2.5 x ULN, or ALAT and ASAT ≥ 5x ULN in case of liver metastases.
* Renal function as defined by serum creatinine ≥ 1.5 x ULN or creatinine clearance ≥ 60 ml/min for patients with creatinine levels ≥ 1.5 x ULN (by Cockcroft-Gault formula).
* WHO performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* No radio- or chemotherapy within the last 4 weeks prior to study entry (palliative limited radiation for pain reduction is allowed)
* Able and willing to swallow oral medication.
* Able and willing to receive iv medication.
* Negative pregnancy test (urine/serum) for female patients with childbearing potential.
Exclusion Criteria:
* Symptomatic cerebral or leptomeningeal metastases.
* 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. (Palliative limited radiation for pain reduction is allowed only between day 8 and day 21 of the study, and allowed to a limited area to palliate pain.
* No prior radiation therapy to more than 30% of the bone marrow and patient must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy.
* More than 1 prior cytotoxic chemotherapy regimen in initial trial. In the additional safety and efficacy cohort: more than 2 prior cytotoxic chemotherapy regimens.
* Prior stem cell or bone marrow transplant.
* Unresolved (\> grade 1) toxicities of previous chemotherapy, excluding alopecia.
* Known hypersensitivity to the components of the combination study therapy or its analogs.
* Patient has had prescription or non-prescription drugs or other products known to be metabolized by CYP3A4, or to inhibit or induce CYP3A4 that cannot be discontinued prior to Day 1 of dosing and withheld throughout the study until 2 days after the last dose of study medication
* Bowel obstructions or motility disorders that may negatively affect oral drug absorption.
* Patients with known alcoholism, drug addiction and/or a history of psychotic disorders who are not suitable for adequate follow up.
* Women who are pregnant or breast feeding.
* Fertile women who do not agree to use a reliable contraceptive method throughout the study.
* Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients.
* Patients with a known history of hepatitis B or C.
* Neurological disease that may render a patient at increased risk for peripheral or central neurotoxicity.
* Clinical history suggestive for Li Fraumeni syndrome.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01164995
Study Brief:
Protocol Section:
NCT01164995