Clinical trial NCT02418624 (phase 1, status: completed)
Conditions: breast cancer, ovarian cancer, advanced cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, K74.02, G47.22, H35.3133, H35.3134, H35.3113, H35.3114, H35.3123
Drugs: carboplatin, olaparib
SMILES: OC1=NN=C(CC2=CC(C(=O)N3CCN(CC3)C(=O)C3CC3)=C(F)C=C2)C2=CC=CC=C12
Eligibility criteria:

        Inclusion criteria:

          1. Histological or cytological proof of advanced cancer pre-treated with maximally one
             line of systemic chemotherapy in the advanced setting and any line of hormonal therapy
             for advanced disease, and potentially benefitting from olaparib-carboplatin
             combination therapy (prior (neo-)adjuvant chemotherapy is accepted and does not count
             as one line, since administered in early stage disease);

          2. Age ≥ 18 years;

          3. Able and willing to give written informed consent;

          4. WHO performance status of 0, 1 or 2;

          5. Able and willing to undergo blood sampling for PK and PD analysis;

          6. Life expectancy ≥ 3 months, allowing adequate follow up of toxicity evaluation and
             antitumor activity;

          7. Evaluable disease according to RECIST 1.1 criteria;

          8. Minimal acceptable safety laboratory values

               1. ANC of ≥ 1.5 x 10^9 /L

               2. Hemoglobin of at least 6.2 mM and no transfusions in the last 28 days.

               3. Platelet count of ≥ 100 x 10^9 /L

               4. Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN (or < 3 x ULN in case
                  of known Gilbert syndrome), ASAT and ALAT 2.5 x ULN (or <5 x ULN in case of liver
                  metastasis)

               5. Renal function as defined by serum creatinine ≤1.5 x ULN or creatinine clearance
                  ≥ 50 mL/min (by Cockcroft-Gault formula);

          9. Negative pregnancy test (urine/serum) for female patients with childbearing potential;

        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;

          2. Patients who have received high dose alkylating agents, a PARP1 inhibitor or
             carboplatin pretreatment; unless no progression on carboplatin had been observed
             during earlier treatment and the last carboplatin administration had been longer than
             6 months ago;

          3. Any current treatment with drugs that induce or inhibit the CYP3A4 system :
             http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteracti
             onslabeling/ucm093664.htm#inVivo or APPENDIX IX

          4. Women who have a positive pregnancy test (urine/serum) and/or who are breast feeding;

          5. Unreliable contraceptive methods. Women and men enrolled in this trial must agree to
             use a reliable contraceptive method throughout the study (adequate contraceptive
             methods are: oral, injected or implanted hormonal methods, intra-uterine devices or
             systems, condom or other barrier contraceptive measures, sterilization and true
             abstinence)

          6. Radiotherapy within the last four weeks prior to receiving the first dose of
             investigational treatment; except 1x8 Gy for pain palliation then a seven days
             interval should be maintained;

          7. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2
             type patients;

          8. Patients with known active hepatitis B or C;

          9. Recent myocardial infarction (< six months) or unstable angina;

         10. Symptomatic brain metastases. If adequately treated with resection and/or irradiation
             and patients are at least four weeks completely free of symptoms of these metastases
             and without medication related to these metastases patients could be eligible if all
             other in- and exclusion criteria are obeyed.

         11. Known leptomeningeal metastases.

         12. Patients with myelodysplastic syndrome or acute myeloid leukemia

         13. Any medical condition not yet specified above that is considered to possibly, probably
             or definitely interfere with study procedures, including adequate follow-up and
             compliance and/or would jeopardize safe treatment.