EUCTR2016-000559-28-GBActive, not recruitingPhase 1
Randomised phase II Trial of olaparib, chemotherapy or olaparib and cediranib in patients with platinum–resistant ovarian cancer - OCTOVA
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- niversity of Oxford
- Enrollment
- 138
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •A patient will be eligible for inclusion in this study if all of the following criteria apply.
- •1.Female patients, aged 16+ years with relapsed epithelial ovarian, primary peritoneal or fallopian tube cancer who have relapsed within 12 months of previous platinum-based therapy. Their most recent chemotherapy does not have to have been platinum-based.
- •2.Patients can have received prior PARP inhibitor and antiangiogenic therapy, but there must be a > 6 month interval since treatment.
- •3.Patients can have received prior antiangiogenic therapy, but there must be a > 6 month interval since treatment; except for bevacizumab where a 6 week interval is required.
- •4.Measurable disease by RECIST Version 1.1 performed in past 4 weeks. At least one lesion, not previously irradiated, that can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes which must have short axis = 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.
- •5.Sufficient archival tissue confirming histological diagnosis available.
- •6.ECOG PS 0-2
- •7.Able to swallow and retain oral medications.
- •8.Life expectancy > 12 weeks in terms of disease related mortality
- •9.Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •10.Written (signed and dated) informed consent prior to any study specific procedures and be capable of co-operating with protocol.
- •11.Patients must have
- •Haemoglobin = 9.0 g/dL and no blood transfusions in the 28 days prior to randomisation
- •12.Patients must have normal organ and bone marrow function measured within 14 days prior to administration of study treatment as defined below:
- •Absolute neutrophil count (ANC) = 1.5 x 109/L
- •Platelet count > 100 x 109/L
- •Total bilirubin = 1.5 x institutional upper limit of normal (ULN)
- •AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be = 5x ULN
- •Serum creatinine = 1.5 x institutional upper limit of normal (ULN) or calculated creatinine clearance >50 ml/min calculated using Cockroft-Gault, Jelliffe or Wright (see Appendix 4)
- •Urine dipstick for proteinuria <2+. If urine dipstick is = 2+ on two occasions more than one week apart then a 24-hour urine must demonstrate = 1 g of protein in 24 hours or protein/creatinine ratio < 1.5.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 84
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
Exclusion Criteria
- •A patient will not be eligible for the trial if any of the following apply:
- •1.Received previous single agent weekly paclitaxel for relapsed disease.
- •2.Pregnant or breast-feeding women or women of childbearing potential unless effective methods of contraception are used during the trial and for 6 months after stopping treatment. Negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1. Pregnancy test will be performed monthly in women of child bearing potential.
- •4.Radiotherapy within 2 weeks from the last dose prior to study treatment
- •5.Started a stable dose of bisphosphonates for bone metastases less than 4 weeks prior to treatment with study drug e.g. patient is eligible and can continue to take bisphosphonates if these were started at least 4 weeks prior to treatment with study drug.
- •6.Concomitant use of known CYP3A4 inhibitors such as ketokonazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.
- •7.Concomitant use of potent inducers of CYP3A4 such as rifampicin, carbamazepine, phenobarbital, phenytoin and St. John Wort.
- •8.Persistent toxicities (>=CTCAE grade 2), with the exception of alopecia, caused by previous cancer therapy.
- •9.Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
- •10.Blood transfusions within 1 month prior to study start
- •11.Patients with myelodysplastic syndrome/acute myeloid leukaemia.
- •12.Patients with symptomatic, untreated, uncontrolled brain or meningeal metastases or tumour.
- •a.A scan to confirm the absence of brain metastases is not required.
- •b.Patients with radiological evidence of stable brain metastases are eligible, providing that they are asymptomatic and:
- •i. Do not require corticosteroids, or
- •ii. Have previously been treated with corticosteroids, with clinical and radiological evidence of stabilisation at least 10 days after discontinuation of steroids
- •iii. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 28 days prior to treatment.
- •13.Major surgery within 14 days of starting study treatment
- •14.Patients who have not recovered from any effects of any major surgery.
- •15.Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
- •16.Any psychiatric disorder that prohibits obtaining informed consent.
- •17.Left Ventricular Ejection Fraction (LVEF) < institutional lower limit of normal, when:
- •Prior treatment with anthracyclines (excluding liposomal doxorubicin)
- •Prior treatment with trastuzumab
- •A NYHA classification of II controlled with treatment (see Appendix 2)
- •Prior central thoracic RT, including RT to the heart
- •History of myocardial infarction within the prior 12 months
- •18.Poorly controlled hypertension (persistently elevated > 150/100mmHg, either systolic or diastolic or both, despite anti-hypertensive medication)
- •19.History of inflammatory bowel disease
- •20.History of cerebrovascular accident (including transient ischaemic attacks) within last 12 months.
- •21.Gastro intestinal impairment that could affect ability to take, or absorption of, oral medicines including sub- acute or complete bowel obstruction
- •22.Evidence of severe or uncontrolled cardiac disease
- •23.Evidence of active bleeding or bleeding diathesis.
- •Defined as significant
Investigators
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