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Ovarian CancerPhase 2OCTOVANCT03117933

Olaparib +/- Cediranib or Chemotherapy in Patients With Platinum-resistant Ovarian Cancer

A Phase 2 study testing Olaparib, Cediranib and Paclitaxel in people with Ovarian Cancer, run by University of Oxford at 14 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The trial will compare the drugs olaparib and cediranib with standard chemotherapy in platinum resistant ovarian cancer. Patients will be randomised to one of three treatment groups: olaparib only, olaparib and cediranib and the control group paclitaxel. Read more about this study

Who is it for?
Ages 16 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Olaparib, Cediranib and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
14 sitesUnited Kingdom
Study dates
9 Mar 2017to 31 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Female patients, age ≥ 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.
  • Patients can have received prior PARP inhibitor, but there must be a > 6 month interval since treatment.
  • 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.
  • 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.
  • Sufficient archival tissue confirming histological diagnosis available.
  • ECOG PS 0-2
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  • Able to swallow and retain oral medications.
  • Life expectancy > 12 weeks in terms of disease related mortality
  • 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.
  • Written (signed and dated) informed consent prior to any study specific procedures and be capable of co-operating with protocol.
  • Patients must have
  • Haemoglobin ≥ 9.0 g/dL and no blood transfusions in the 28 days prior to randomisation
  • 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.

Who cannot join

  • Received previous single agent weekly paclitaxel for relapsed disease.
  • 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.
  • Postmenopausal is defined as:
  • Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments
  • LH and FSH levels in the post-menopausal range for women under 50,
  • radiation-induced oophorectomy with last menses >1 year ago,
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  • chemotherapy-induced menopause with >1 year interval since last menses, or surgical sterilisation (bilateral oophorectomy or hysterectomy).
  • Treatment with any other investigational agent, systemic chemotherapy, or participation in another interventional clinical trial within 28 days prior to enrolment.
  • Radiotherapy within 2 weeks from the last dose prior to study treatment
  • 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.
  • Concomitant use of known CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.
  • Concomitant use of potent inducers of CYP3A4 such as rifampicin, carbamazepine, phenobarbital, phenytoin and St. John Wort.
  • Persistent toxicities (>=CTCAE grade 2) caused by previous cancer therapy with the exception of alopecia.
  • Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
  • Blood transfusions within 1 month prior to study start
  • Patients with myelodysplastic syndrome/acute myeloid leukaemia.
  • Patients with symptomatic, untreated, uncontrolled brain or meningeal metastases or tumour.
  • 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.
  • Major surgery within 14 days of starting study treatment
  • Patients who have not recovered from any effects of any major surgery.
  • Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on HRCT scan
  • Any psychiatric disorder that prohibits obtaining informed consent.
  • Left Ventricular Ejection Fraction (LVEF) < institutional lower limit of normal, when:
  • Prior treatment with anthracyclines (excluding liposomal doxorubicin) ii. Prior treatment with trastuzumab iii. A NYHA classification of II controlled with treatment (see Appendix 2) iv. Prior central thoracic RT, including RT to the heart v. History of myocardial infarction within the prior 12 months
  • Poorly controlled hypertension (persistently elevated > 150/100mmHg, either systolic or diastolic or both, despite anti-hypertensive medication)
  • History of inflammatory bowel disease
  • History of cerebrovascular accident (including transient ischaemic attacks) within last 12 months.
  • Gastro intestinal impairment that could affect ability to take, or absorption of, oral medicines including sub- acute or complete bowel obstruction
  • Evidence of severe or uncontrolled cardiac disease
  • Evidence of active bleeding or bleeding diathesis. Defined as significant haemorrhage (>30mL bleeding/episode in previous 3 months) or haemoptysis (>5mL fresh blood in previous 4 weeks)
  • Known treatment-limiting hypersensitivity to cediranib, olaparib, paclitaxel or any of its excipients
  • Other psychological, social or medical condition, physical examination finding or a laboratory abnormality that the Investigator considers would make the patient a poor trial candidate or could interfere with protocol compliance or the interpretation of trial results.
  • Any other active malignancy, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and non-melanoma skin lesions, requiring treatment/or whose prognosis will prevent readout from trial endpoints.
  • Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.
  • 28 Immunocompromised patients e.g., patients who are taking immunosuppressive drugs.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United Kingdom14 sites

  • Royal United Hospital

    Bath

  • Belfast City Hospital

    Belfast, County Antrim, BT9 7AM

  • Velindre

    Cardiff

  • Beatson West of Scotland Cancer Centre

    Glasgow

  • Royal Surrey County Hospital

    Guildford, Surrey, GU2 7XX

  • Clatterbridge Cancer Centre

    Liverpool

  • St Bartholomew's

    London, EC1A 7BE

  • Hammersmith Hospital

    London, W12 0HS

  • Royal Marsden Chelsea & Sutton

    London

  • University College London

    London

  • The Christie

    Manchester

  • Mount Vernon Cancer Centre

    Northwood, Middlesex

  • City Hospital Nottingham

    Nottingham, Nottinghamshire, NG5 1PB

  • Churchill Hospital

    Oxford, OX3 7LE

Other trials in United Kingdom

About this study

Official title: Randomised Phase II Trial of Olaparib, Chemotherapy or Olaparib and Cediranib in Patients With Platinum-resistant Ovarian Cancer

The trial will compare the drugs olaparib and cediranib with standard chemotherapy in platinum resistant ovarian cancer. Patients will be randomised to one of three treatment groups: olaparib only, olaparib and cediranib and the control group paclitaxel. The aim is to compare efficacy of the 3 treatments and also how well each treatment is tolerated including the participants quality of life.

Read the detailed description

Olaparib is a PARP inhibitor which targets BRCA1/2 mutated tumour cells and cediranib is an anti-angiogenic drug which reduces blood supply to the tumour, suppressing tumour viability. Phase I/II trials of both drugs have shown these are well tolerated alone or in combination in ovarian cancer.

The trial aims to compare the efficacy of the combination and of olaparib alone with paclitaxel chemotherapy and whether the olaparib/cediranib combination is better tolerated thus improving quality of life. Secondly standard paclitaxel chemotherapy must be administered weekly at hospital whereas the olaparib/cediranib combination can be administered at home potentially also improving patient quality of life.

Participants' tumours will be resistant to platinum based therapies. Participants will be randomised into one of the 3 treatment arms after stratification for prior PARP/anti-angiogenic treatments/BRCA status. Participants will be on trial up to 18 months.

Conditions
Ovarian Cancer
Being tested
Olaparib, Cediranib, Paclitaxel
Keywords
BRCA1/2 mutation, Platinum resistance
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlaparibDrug

    Tablet, 100mg and 150mg

  • CediranibDrug

    Tablet 15mg and 20mg

  • PaclitaxelDrug

    Intravenous (IV)

Study groups in NCT03117933
Study groupRoleWhat they receive
A: PaclitaxelActive comparatorPaclitaxel, IV weekly, 80mg/m2; until progression
Receives: Drug: Paclitaxel
B: OlaparibExperimentalOlaparib, oral, 300mg twice daily; until progression
Receives: Drug: Olaparib
C: Olaparib and CediranibExperimentalOlaparib, oral, 300mg twice daily and Cediranib, tablet, 20mg once daily; until progression
Receives: Drug: Olaparib; Drug: Cediranib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Progression free survival (PFS), measured as time from date of randomisation to RECIST-defined progression or death from any cause (whichever is first)

    Measured: up to 18 months

Secondary outcomes (7)

  1. Adverse events

    Adverse events using CTCAE v4.03

    Measured: up to 18 months

  2. Overall Survival

    Overall Survival

    Measured: 12 & 18 months

  3. Objective Response Rate

    Objective Response Rate based on RECIST v1.1

    Measured: up to 18 months

  4. Objective Response Rate

    Objective Response Rate based GCIG CA125

    Measured: up to 18 months

  5. Quality of Life Outcomes

    Quality of Life Outcomes based on EORTC-QLQ C30

    Measured: up to 18 months

  6. Quality of Life Outcomes

    Quality of Life Outcomes based on EQ5D

    Measured: up to 18 months

  7. Quality of Life Outcomes

    Quality of Life Outcomes based on OV28.

    Measured: up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2017
  2. Study start9 Mar 2017
  3. Primary completion12 Mar 2021
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised open label trial with 3 arms, stratified for prior PARP use, prior anti-angiogenic use and BRCA status.
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03117933
Sponsor's protocol ID
OCTO_062
Other IDs
2016-000559-28, 16/LO/2150, 2016
Acronym
OCTOVA
Status last verified
Jan 2024
First submitted
21 Mar 2017
Last updated
23 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

    PubMed 37185961

  • Mansouri A, McGregor N, Dunn R, Dobbie S, Holmes J, Collins L, Nicum S. Randomised phase II trial of olaparib, chemotherapy or olaparib and cediranib in patients with platinum-resistant ovarian cancer (OCTOVA): a study protocol. BMJ Open. 2021 Jan 15;11(1):e041463. doi: 10.1136/bmjopen-2020-041463.

    PubMed 33452192

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib, Cediranib and Paclitaxel in people with Ovarian Cancer, run by University of Oxford at 14 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03117933, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.

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