cancer in organs Solid tumors
Conditions
Interventions
Patients will be treated weekly with carboplatin intravenous on the first day
of each week and with AZD1775 in 5 doses per week (2.5 days). The remaining
days of the week patients will not receive t
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Histological or cytological proof of advanced p53 mutated cancer, pre-treated with maximally one line of systemic chemotherapy in the advanced setting and any line of hormonal or immunotherapy for advanced disease, and potentially benefitting from carboplatin-AZD1775 combination therapy (prior (neo-)adjuvant chemotherapy is accepted and does not count as one line, since administered in early stage disease); 5. Able and willing to undergo blood sampling for PK and PD analysis; 6. Able and willing to undergo a tumor biopsy (if p53 status is already known, tumor biopsy is still mandatory) 8. Evaluable disease according to RECIST 1.1 criteria;
Exclusion criteria
Exclusion criteria: 1. Any treatment with investigational drugs within 28 days prior to receiving the first dose of investigational treatment; or 21 days for standard (neo-)adjuvant chemotherapy, hormonal and immunotherapy; 6. Unresolved (> grade 1) toxicities of previous chemotherapy, excluding alopecia. 8. 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 two weeks prior to Day 1 of dosing and withheld throughout the study until 1 week after the last dose of study medication. 17. Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) >= Class 2. o Unstable angina pectoris o Congestive heart failure o Acute myocardial infarction o Conduction abnormality not controlled with pacemaker or medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerable dose of the combination therapy of weekly carboplatin with the Wee-1 inhibitor AZD1775 | — |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary response rate Pharmacokinetics | — |
Countries
Netherlands
Outcome results
None listed