Abiraterone treatment for patients with relapsed ovarian cancer.

Phase 1

• Conditions: Epithelial ovarian cancer (including fallopian tube and primary peritoneal); MedDRA version: 19.0Level: PTClassification code 10061328Term: Ovarian epithelial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000293-29-GB
• Lead Sponsor: The Royal Marsden NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-27
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 47

Inclusion Criteria

1) Patients must have histologically or cytologically confirmed epithelial ovarian, fallopian tube (FT) or primary peritoneal (PP) cancer and have progressed (radiological or CA125 criteria) within 12 months of last systemic anti-cancer therapy
2) Life expectancy of at least 12 weeks
3) Post-menopausal defined as:
•Aged = 18 years having had bilateral salpingo-oophorectomy (BSO)
•Aged = 45 years with intact uterus and amenorrhoeic for at least 12 months
•FSH >40 U/L in patients who have had a hysterectomy and ovaries are intact (i.e. not had bilateral oophorectomy)
Documentary evidence is required for patients who have undergone irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy
4) ECOG performance status of 0-2
5) Patients must not have had prior hormone therapy (e.g. tamoxifen, aromatase inhibitor, progestogens, anti-androgens)
6) Patients will have received at least one line of prior platinum-based chemotherapy
7) Measurable or evaluable disease (if not measurable by RECIST v1.1 criteria, patients must be evaluable by GCIG CA125 criteria)
8) Archival tumour tissue (FFPE or 8-10 unstained slides) must be available. Otherwise, a biopsy must be carried out to obtain sufficient tissue for histological assessment
9) Haematological and biochemical indices within acceptable ranges (as specified in the protocol)
10) Aged 18 years or over
11) Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up

Are the trial subjects under 18? no
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 47
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1) Tumours of mucinous, clear cell, malignant mixed mesodermal (MMMT) or non-epithelial ovarian cancers (e.g. Brenner tumours, Sex-cord tumours)
2) Radiotherapy (except for palliative reasons) or chemotherapy within the preceding three weeks (four weeks for investigational agent or within five half-lives of the investigational agent, whichever is longer)
3) Persistent grade 2 or greater toxicities from any cause except for alopecia or grade 2 peripheral neuropathy
4) Known leptomeningeal involvement or brain metastases
5) Clinical and/or biochemical evidence of hyperaldosteronism or hypopituitarism
6) Unresolved bowel obstruction
7) Major surgery within four weeks prior to commencement of trial treatment
8) Treatment with warfarin. Patients on warfarin for DVT/PE can be converted to LMWH at least one week prior to commencement of trial treatment
9) At high medical risk because of non-malignant systemic disease including active uncontrolled infection
10) Known to be serologically positive for hepatitis B and/or hepatitis C
11) Active or uncontrolled autoimmune disease that may require corticosteroid therapy
12) History of clinically significant heart disease, e.g. myocardial infarction or arterial thrombotic event within six months, severe or unstable angina, or New York Heart Association Class III or IV heart disease
13) Systolic blood pressure >160 mm Hg and diastolic blood pressure >95 mm Hg documented on at least two different occasions
[Note: Hypertension controlled by antihypertensive therapy is permitted].
14) Any other active malignancy requiring treatment
15) Patients for whom treatment with prednisone or prednisolone is contraindicated
16) Patients participating in or planning to participate in another interventional clinical trial. Participation in an observational trial is acceptable
17) Any other condition which, in the Investigator’s opinion, would not make the patient a good candidate for the clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified