Ovarian CancerPhase 3EXPERTNCT04460807
Exemestane in Hormone Receptor Positive High Grade Ovarian Cancer
A Phase 3 study testing Exemestane in people with Ovarian Cancer, run by Ente Ospedaliero Ospedali Galliera at 47 sites in Italy.
Trial summary
In this Italian, multicenter, randomized, double-blind, placebo controlled, phase III study the efficacy of exemestane will be evaluated in addition to the standard front line treatment in patients with hormone-receptor-positive high grade serous or endometrioid Epithelian Ovarian Cancer (EOC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Exemestane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 47 sitesItaly
- Study dates
- 13 Feb 2020to 27 Apr 2023
- Phase
- Phase 3
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Citologically or histologically confirmed high grade serous or endometrial epithelial ovarian cancer, including cancer of fallopian tube and peritoneum. For patients who are candidates for neoadjuvant chemotherapy, diagnosis must be documented via imaging or a core tissue (not fine needle aspiration) biopsy.
- Disease stage IIB to IV according to FIGO classification. For patients who are candidates for neoadjuvant chemotherapy, stage IIB-IV should be documented via imaging or a core tissue (not fine needle aspiration) biopsy.
- Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy. For patients enrolling after debulking surgery, randomization should occur at a maximum of 12 weeks and not before 4 weeks after surgery.
- Immunoistochemically determined positivity (≥ 10%) for Progesterone and/or Estrogen receptor expression, including determination on cytology smears from ascitic fluid if surgery is differed.
- Measurable or evaluable disease confirmed by radiological imaging, or histological proven ovarian cancer in the absence of postoperatively measurable or evaluable lesions
- Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2.
- Written, informed consent obtained prior to any study-specific procedures.
Who cannot join
- Previous systemic therapy for ovarian cancer.
- Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
- Inadequate bone marrow, hepatic or renal functions, assessed within 7 days prior to randomization.
- Treatment with hormonal contraceptives during the previous 3 months from diagnosis.
- Concurrent comorbidities, which contraindicates the administration of chemotherapy, or endocrine therapy.
- Pregnant or lactating patients.
- Inability or unwillingness to swallow tablets.
Trial locations and contacts
47 sites in 1 country.
47 sites in 1 country
Italy47 sites
Azienda Sanitaria Locale CN2
Alba, CN
AO SS Antonio e Biagio e Cesare Arrigo
Alessandria, AL
CRO Centro di Riferimento Oncologico
Aviano, PN
Ospedale Oncologico IRCCS Bari
Bari, BA
Ospedale degli Infermi
Biella, BI
Azienda Ospedaliero Universitaria Policlinico S.Orsola-Malpighi
Bologna, BO
ASST degli Spedali Civili di Brescia
Brescia, BS
Fondazione Poliambulanza
Brescia, BS
AOU Cagliari, Policlinico Universitario
Cagliari, CA
Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo, TO
ARNAS Garibaldi
Catania, CT
Azienda Ospedaliera per l'emergenza Cannizzaro
Catania, CT
Ospedale Policlinico "SS. Annunziata"
Chieti, CH
Ospedale Sant Anna di Como
Como, CO
Azienda Ospedaliera S.Croce e Carle
Cuneo, CN
Ospedale "degli Infermi"
Faenza, RA
AULSS 1 Dolomiti - Ospedale "Santa Maria del Prato"
Feltre, BL
ASL 3 Ospedale Villa Scassi
Genova, GE
IRCCS AOU San Martino - IST
Genova, GE
Medical Oncology Division, Ente Ospedaliero Ospedali Galliera
Genova, 16128
Ospedale "Vito Fazzi"
Lecce, LE
ASST Lecco - Ospedale "A. Manzoni"
Lecco, LC
Ospedale "Umberto I"
Lugo, RA
Ospedale di Manerbio
Manerbio, BS
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
Meldola, FC
Istituto Europeo di Oncologia (IEO)
Milan, MI
AOU Policlinico di Modena
Modena, MO
Ospedale di Mondovì CN1
Mondovì, CN
UOS Oncologia Ginecologica, Ospedale S. Gerardo
Monza, MB
Istituto Nazionale Tumori - IRCCS "Fondazione G.Pascale"
Naples
Azienda Ospedaliero-Universitaria Maggiore della Carità
Novara
A.R.N.A.S. Ospedali Civico Di Cristina Benfratelli
Palermo, PA
Fondazione IRCCS Policlinico San Matteo
Pavia, PV
Ospedale "Guglielmo da Saliceto"
Piacenza, PC
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI
Azienda Ospedaliera Regionale San Carlo
Potenza, PZ
Presidio Ospedaliero Unico Av3
Province of Macerata, MC
Ospedale Santa Maria delle Croci
Ravenna, RA
Azienda Ospedaliera Arcispedale Santa Maria Nuova
Reggio Emilia, RE
Policlinico Umberto I, Università di Roma "La Sapienza"
Roma, RM
Policlinico Universitario Fondazione Agostino Gemelli
Roma, RM
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG
Azienda Ospedaliero Universitaria di Sassari
Sassari, SS
ASST Valtellina e Alto Lario
Sondrio, SO
AO Ordine Mauriziano
Torino, TO
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza - Ospedale Ostetrico Ginecologico Sant'Anna
Torino, TO
Presidio Ospedaliero S. Andrea
Vercelli, VC
About this study
Official title: EXemestane in Progesterone and/or Estrogen Receptor Positive Epithelial Ovarian Cancer: A Randomized Phase III Trial, EXPERT
In this Italian, multicenter, randomized, double-blind, placebo controlled, phase III study the efficacy of exemestane will be evaluated in addition to the standard front line treatment in patients with hormone-receptor-positive high grade serous or endometrioid Epithelian Ovarian Cancer (EOC). The patients enrolled in the EXPERT trial will receive exemestane or placebo in addition to standard treatment. Patients and investigators will be blinded to study treatment.
The hypothesis underlying the proposed clinical trial is that exemestane added to standard first line therapy will significantly prolong median progression free survival (PFS).
Read the detailed description
Estrogen and Progesterone play a role in promoting EOC growth, metastasis, and progression. Recent data show that ER and PgR expression is frequent in high grade EOC and has prognostic significance. A large meta-analysis showed a clinical benefit with any endocrine treatment, and in particular for aromatase inhibitors (AIs), with a greatere benefit for ER+ and/or PgR+ patients and platinum sensitive tumors. Moreover, the analysis of a few randomized clinical trials (RCTs) showed a reduced mortality with endocrine therapy in EOC, suggesting that ER and PgR have a predictive role and that inhibition of their activation could therefore be a treatment option for EOC.
Exemestane is a well-tolerated and effective AI in endocrine sensitive breast cancer which inhibits the production of Estrogens by the adipose tissue in postmenopausal women.
In this Italian, multicentre, randomized, double-blind, placebo controlled, phase III study will be assessed the efficacy of exemestane versus placebo in addition to the standard front line treatment in patients with high grade serous or endometrioid EOC, IHC positive (≥ 10%) ER or PgR disease, stage IIB - IV according to the FIGO classification.
The primary objective of the study is to test the superiority of exemestane over placebo in addition to the standard front line treatment in terms of PFS.
Secondary Objectives are:
- to test whether the percent expression of ER and PgR is predictive of the effect of exemestane on PFS;
- to test whether the addition of exemestane to the standard front line treatment can prolong Overall Survival (OS);
- to evaluate objective response rate Overall Response Rate (ORR) of experimental treatment compared with the standard one;
- to assess whether the effect of exemestane is affected by the proliferative index Ki67;
- to evaluate the effect of exemestane on Quality of Life (QoL);
- to evaluate the compliance to the study treatment;
- to evaluate the safety profile of the experimental treatment compared with the standard one.
Study design: a total of 468 subjects (234 per Arm) will be randomized in a 1:1 ratio to receive either standard chemotherapy treatment plus exemestane (Experimental arm) or standard chemotherapy plus placebo (Control arm). Exemestane/placebo will be self-administered as a single oral tablet of 25 mg/day until disease progression, unacceptable toxicity or physician/patient decision to withdraw, whichever comes first. Radiological disease assessments and CA125 will be performed at baseline and every 4 months from randomization, until end of study or disease progression whichever comes first. Safety assessments will be performed at each cycle during standard chemotherapy treatment, then at each study visit, up to 30 days after the last Experimental Treatment administration.Quality of Life will be assessed by a menopause-specific questionnaire, administered to patients at baseline (T0), at 12 months (T1) and at disease progression (T2). For patients who have signed the specific informed consent, tissues and blood samples will be collected.
- Conditions
- Ovarian Cancer
- Being tested
- Exemestane, Placebo oral tablet
- Keywords
- exemestane, aromatase inhibitors, clinical trial, phase 3, receptors, estrogen, receptors, progesterone
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExemestaneDrug
Also called Mestane
Exemestane in addition to standard therapy, in Experimental arm.
Placebo oral tabletOther
Placebo in addition to standard therapy, in Control arm.
| Study group | Role | What they receive |
|---|---|---|
| Exemestane | Experimental | Standard chemotherapy: paclitaxel 175 mg/m2 + carboplatin AUC 5, on day 1 every 21 days ± bevacizumab 15mg/kg, on day 1 every 21 days. Chemotherapy will be administered for 6 cycles; Bevacizumab will be administered as up to a maximum of 22 cycles. Patients unfit for standard treatment can receive a weekly schedule of treatment or monotherapy with carboplatin alone. Neoadjuvant chemotherapy is allowed in patients unfit for primary elective surgery.
+
Exemestane: single oral tablet of 25 mg/day until disease progression, unacceptable toxicity or physician/patient decision to withdraw, whichever comes first. Receives: Drug: Exemestane |
| Placebo | Placebo comparator | Standard chemotherapy : paclitaxel 175 mg/m2 + carboplatin AUC 5, on day 1 every 21 days ± bevacizumab 15mg/kg, on day 1 every 21 days. Chemotherapy will be administered for 6 cycles; Bevacizumab will be administered as up to a maximum of 22 cycles. Patients unfit for standard treatment can receive a weekly schedule of treatment or monotherapy with carboplatin alone. Neoadjuvant chemotherapy is allowed in patients unfit for primary elective surgery.
+
Placebo: single oral tablet until disease progression, unacceptable toxicity or physician/patient decision to withdraw, whichever comes first. Receives: Other: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
PFS id defined for each patient as the time from the date of randomization to the date of local or regional relapse, distant metastasis, second primary malignancy or death from any cause, whichever comes first. Patients not recurred, progressed or died while on study or lost to follow-up will be censored at their last disease assessment date.
Measured: Up to 20 months
Secondary outcomes (7)
Overall survival (OS)
OS is defined for each patient as the time from the date of randomization to the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive.
Measured: Up to 20 months
Objective Response Rate (ORR)
ORR is defined as the number of patients who will experience a complete or partial response divided by the number of patients randomized with at least one target lesion at baseline. Each patient will be assigned the best response ever recorded during the trial
Measured: a CT-scan will be performed every 4 months. Up to 20 months from last patients randomized
Quality of Life: Menopause Quality of Life (MENQoL) questionnaire
The effect of study treatment will be assessed based on the MENQOL intervention questionnaire based on 29 items divided in four domains (vasomotor, physical, psychosocial and sexual), each scored from 1 to 8 (1 means no symptom, 2 presence of the symptoms but not bothersome, 3-8 an increasing grade of discomfort). Mean changes from the baseline domain scores between treatment arms will be evaluated.
Measured: Up to 20 months
Compliance - Number of administered cycles
Number of administered cycles
Measured: Up to 20 months
Compliance - Reasons for discontinuation and treatment modification
Number of patients for each reasons
Measured: Up to 20 months
Compliance - Dose intensity
Number of tablets taken (i.e., number of tablets given-number of tablets returned)/number of tablets that should have been taken during the treatment period.
Measured: Up to 20 months
Safety (Adverse Events)
Maximum toxicity grade experienced by each patient for each toxicity, proportion of patients experiencing grade 3-4 toxicity for each toxicity, type, frequency and nature of serious adverse events (SAEs).
- Proportion of patients with at least one SAE.
- Proportion of patients with at least one serious adverse drug reaction (SADR).
Measured: Up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start13 Feb 2020
- Primary completion27 Apr 2023
- Study completion27 Apr 2023
Why it stopped: low accrual, COVID 19 emergency and the modification of the standard of care for ovarian cancer treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Ospedali Galliera
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Di Ricerche Farmacologiche Mario Negri, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Federation of Italian Cooperative Oncology Groups
- Responsible party
- Principal investigator, Andrea DeCensi, Ente Ospedaliero Ospedali Galliera
- Investigators
- Andrea DeCensi, Principal investigator, E.O. Ospedali Galliera Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460807
- Sponsor's protocol ID
- 56UCS2017
- Other IDs
- 2018-000693-30, 2018
- Acronym
- EXPERT
- Status last verified
- Feb 2024
- First submitted
- 27 Apr 2020
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the primary publication of the trial will be shared (text, tables, figures, and appendices), after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXemestane in Progesterone and/or Estrogen Receptor Positive Epithelial Ovarian Cancer: A Randomized Phase III Trial, EXPERT
- ClinicalTrials.gov ID
- NCT04460807
- Acronym / sponsor ID
- EXPERT / 56UCS2017
- Conditions
- Ovarian Cancer
- Keywords
- exemestane, aromatase inhibitors, clinical trial, phase 3, receptors, estrogen, receptors, progesterone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual, COVID 19 emergency and the modification of the standard of care for ovarian cancer treatment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ente Ospedaliero Ospedali GallieraUniversity, hospital or other
- Collaborators
- Istituto Di Ricerche Farmacologiche Mario Negri, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Federation of Italian Cooperative Oncology Groups
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this Italian, multicenter, randomized, double-blind, placebo controlled, phase III study the efficacy of exemestane will be evaluated in addition to the standard front line treatment in patients with hormone-receptor-positive high grade serous or endometrioid Epithelian Ovarian Cancer (EOC). The patients enrolled in the EXPERT trial will receive exemestane or placebo in addition to standard treatment. Patients and investigators will be blinded to study treatment.
The hypothesis underlying the proposed clinical trial is that exemestane added to standard first line therapy will significantly prolong median progression free survival (PFS).
Detailed description
Estrogen and Progesterone play a role in promoting EOC growth, metastasis, and progression. Recent data show that ER and PgR expression is frequent in high grade EOC and has prognostic significance. A large meta-analysis showed a clinical benefit with any endocrine treatment, and in particular for aromatase inhibitors (AIs), with a greatere benefit for ER+ and/or PgR+ patients and platinum sensitive tumors. Moreover, the analysis of a few randomized clinical trials (RCTs) showed a reduced mortality with endocrine therapy in EOC, suggesting that ER and PgR have a predictive role and that inhibition of their activation could therefore be a treatment option for EOC.
Exemestane is a well-tolerated and effective AI in endocrine sensitive breast cancer which inhibits the production of Estrogens by the adipose tissue in postmenopausal women.
In this Italian, multicentre, randomized, double-blind, placebo controlled, phase III study will be assessed the efficacy of exemestane versus placebo in addition to the standard front line treatment in patients with high grade serous or endometrioid EOC, IHC positive (≥ 10%) ER or PgR disease, stage IIB - IV according to the FIGO classification.
The primary objective of the study is to test the superiority of exemestane over placebo in addition to the standard front line treatment in terms of PFS.
Secondary Objectives are:
- to test whether the percent expression of ER and PgR is predictive of the effect of exemestane on PFS;
- to test whether the addition of exemestane to the standard front line treatment can prolong Overall Survival (OS);
- to evaluate objective response rate Overall Response Rate (ORR) of experimental treatment compared with the standard one;
- to assess whether the effect of exemestane is affected by the proliferative index Ki67;
- to evaluate the effect of exemestane on Quality of Life (QoL);
- to evaluate the compliance to the study treatment;
- to evaluate the safety profile of the experimental treatment compared with the standard one.
Study design: a total of 468 subjects (234 per Arm) will be randomized in a 1:1 ratio to receive either standard chemotherapy treatment plus exemestane (Experimental arm) or standard chemotherapy plus placebo (Control arm). Exemestane/placebo will be self-administered as a single oral tablet of 25 mg/day until disease progression, unacceptable toxicity or physician/patient decision to withdraw, whichever comes first. Radiological disease assessments and CA125 will be performed at baseline and every 4 months from randomization, until end of study or disease progression whichever comes first. Safety assessments will be performed at each cycle during standard chemotherapy treatment, then at each study visit, up to 30 days after the last Experimental Treatment administration.Quality of Life will be assessed by a menopause-specific questionnaire, administered to patients at baseline (T0), at 12 months (T1) and at disease progression (T2). For patients who have signed the specific informed consent, tissues and blood samples will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exemestane | Experimental | Drug: ExemestaneStandard chemotherapy: paclitaxel 175 mg/m2 + carboplatin AUC 5, on day 1 every 21 days ± bevacizumab 15mg/kg, on day 1 every 21 days. Chemotherapy will be administered for 6 cycles; Bevacizumab will be administered as up to a maximum of 22 cycles. Patients unfit for standard treatment can receive a weekly schedule of treatment or monotherapy with carboplatin alone. Neoadjuvant chemotherapy is allowed in patients unfit for primary elective surgery. + Exemestane: single oral tablet of 25 mg/day until disease progression, unacceptable toxicity or physician/patient decision to withdraw, whichever comes first. |
| Placebo | Placebo comparator | Other: Placebo oral tabletStandard chemotherapy : paclitaxel 175 mg/m2 + carboplatin AUC 5, on day 1 every 21 days ± bevacizumab 15mg/kg, on day 1 every 21 days. Chemotherapy will be administered for 6 cycles; Bevacizumab will be administered as up to a maximum of 22 cycles. Patients unfit for standard treatment can receive a weekly schedule of treatment or monotherapy with carboplatin alone. Neoadjuvant chemotherapy is allowed in patients unfit for primary elective surgery. + Placebo: single oral tablet until disease progression, unacceptable toxicity or physician/patient decision to withdraw, whichever comes first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years
- Citologically or histologically confirmed high grade serous or endometrial epithelial ovarian cancer, including cancer of fallopian tube and peritoneum. For patients who are candidates for neoadjuvant chemotherapy, diagnosis must be documented via imaging or a core tissue (not fine needle aspiration) biopsy.
- Disease stage IIB to IV according to FIGO classification. For patients who are candidates for neoadjuvant chemotherapy, stage IIB-IV should be documented via imaging or a core tissue (not fine needle aspiration) biopsy.
- Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy. For patients enrolling after debulking surgery, randomization should occur at a maximum of 12 weeks and not before 4 weeks after surgery.
- Immunoistochemically determined positivity (≥ 10%) for Progesterone and/or Estrogen receptor expression, including determination on cytology smears from ascitic fluid if surgery is differed.
Key exclusion criteria (7 listed)
- Previous systemic therapy for ovarian cancer.
- Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
- Inadequate bone marrow, hepatic or renal functions, assessed within 7 days prior to randomization.
- Treatment with hormonal contraceptives during the previous 3 months from diagnosis.
- Concurrent comorbidities, which contraindicates the administration of chemotherapy, or endocrine therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExemestaneAlso: MestaneExemestane in addition to standard therapy, in Experimental arm. | Drug | Exemestane |
| Placebo oral tabletPlacebo in addition to standard therapy, in Control arm. | Other | Placebo |
Primary outcome
Progression free survival (PFS)
Time frame: Up to 20 months
PFS id defined for each patient as the time from the date of randomization to the date of local or regional relapse, distant metastasis, second primary malignancy or death from any cause, whichever comes first. Patients not recurred, progressed or died while on study or lost to follow-up will be censored at their last disease assessment date.
7 secondary outcomes
Overall survival (OS)
Time frame: Up to 20 months
Objective Response Rate (ORR)
Time frame: a CT-scan will be performed every 4 months. Up to 20 months from last patients randomized
Quality of Life: Menopause Quality of Life (MENQoL) questionnaire
Time frame: Up to 20 months
Compliance - Number of administered cycles
Time frame: Up to 20 months
Compliance - Reasons for discontinuation and treatment modification
Time frame: Up to 20 months
Compliance - Dose intensity
Time frame: Up to 20 months
Safety (Adverse Events)
Time frame: Up to 20 months
Results and safety
The study was stopped early (reason given: low accrual, COVID 19 emergency and the modification of the standard of care for ovarian cancer treatment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the primary publication of the trial will be shared (text, tables, figures, and appendices), after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea DeCensi principal investigator
E.O. Ospedali Galliera Genova
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exemestane in people with Ovarian Cancer, run by Ente Ospedaliero Ospedali Galliera at 47 sites in Italy.
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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Italy. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: low accrual, COVID 19 emergency and the modification of the standard of care for ovarian cancer treatment). Results are not available in the source record.
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 (PFS) (time frame: Up to 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2024.