CompletedPhase 1

Phase I of Carboplatin-Olaparib Followed by Olaparib Monotherapy in Advanced Cancer

Netherlands25 participantsStarted 2015-05

Plain-language summary

A phase I trial to determine the recommended phase two dose of the combination of carboplatin and olaparib.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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);
✓. Age ≥ 18 years;
✓. Able and willing to give written informed consent;
✓. WHO performance status of 0, 1 or 2;
✓. Able and willing to undergo blood sampling for PK and PD analysis;
✓. Life expectancy ≥ 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity;
✓. Evaluable disease according to RECIST 1.1 criteria;
✓. Minimal acceptable safety laboratory values

✕. 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;
✕. 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;
✕. Any current treatment with drugs that induce or inhibit the CYP3A4 system : http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm093664.htm#inVivo or APPENDIX IX
✕. Women who have a positive pregnancy test (urine/serum) and/or who are breast feeding;
✕. 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)
✕. 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;
✕. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
✕. Patients with known active hepatitis B or C;

Maximum Tolerated Dose

Timeframe: per doselevel of 3 to 6 patients (when 3-6 patients have completed DLT period of 3 weeks)

NCT IDNCT02418624

SponsorThe Netherlands Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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);
✓. Age ≥ 18 years;
✓. Able and willing to give written informed consent;
✓. WHO performance status of 0, 1 or 2;
✓. Able and willing to undergo blood sampling for PK and PD analysis;
✓. Life expectancy ≥ 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity;
✓. Evaluable disease according to RECIST 1.1 criteria;
✓. Minimal acceptable safety laboratory values

✕. 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;
✕. 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;
✕. Any current treatment with drugs that induce or inhibit the CYP3A4 system : http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/druginteractionslabeling/ucm093664.htm#inVivo or APPENDIX IX
✕. Women who have a positive pregnancy test (urine/serum) and/or who are breast feeding;
✕. 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)
✕. 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;
✕. Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
✕. Patients with known active hepatitis B or C;