Ovarian NeoplasmsPhase 2BAROCCONCT03314740
Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib
A Phase 2 study testing Paclitaxel, Cediranib and Olaparib in people with Ovarian Neoplasms, run by Mario Negri Institute for Pharmacological Research at 6 sites in Italy.
Trial summary
This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in platinum refractory or resistant recurrent ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Paclitaxel, Cediranib and Olaparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 6 sitesItaly
- Study dates
- 12 Jun 2017to 1 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients affected by pathologically confirmed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Relapsed/progressive disease within 6 months from last platinum-based chemotherapy (platinum resistant/refractory disease).
- Any line of treatment (after the first).
- Any "last" chemotherapy line, including Paclitaxel, that should have been administered at least 6 months before the study beginning.
- Patients must be women > 18 years of age.
- Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
Show all 24Show fewer
- Haemoglobin ≥ 10.0 g/dL and no blood transfusions in the 28 days prior to entry/randomization - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- White blood cells (WBC) > 3x109/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
- Creatinine clearance estimated using the Cockcroft-Gault equation ≥51 mL/min,.
- ECOG performance status 0-1.
- Patients must have a life expectancy ≥ 16 weeks.
- Evidence of non-childbearing status for women of childbearing potential (negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment on day 1 or postmenopausal women. Postmenopausal status 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,
- Chemotherapy-induced menopause with >1 year interval since last menses
- Surgical sterilization (bilateral oophorectomy or hysterectomy)
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations including follow up.
- At least one lesion (measurable as defined by RECIST 1.1) that can be accurately assessed by CT scan or MRI with Chest X-ray at baseline and follow up visits.
- BRCA1-2 mutation status known. In case of BRCA status unknown, the BRCA test must be performed before the randomization or, if not feasible, within the end-of the study treatment.
- Provision of informed consent prior to any study specific procedures. In case of patients unable to give written informed consent, is necessary to have the subject or legal representative sign, but in any case a witness must be present and sign and date with the person providing informed consent.
Who cannot join
- Any previous treatment with a PARP inhibitor, including Olaparib.
- Prior treatment with Cediranib (previous bevacizumab or other antiangiogenic drugs are allowed)
- Previous progression to weekly Paclitaxel
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years
- Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug.
- Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting Olaparib is 2 weeks.
Show all 25Show fewer
- Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting Olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
- Persistent toxicities (>=CTCAE grade 2) with the exception of alopecia, caused by previous cancer therapy.
- Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
- Greater than +1 proteinuria on two consecutive dipsticks taken no less than 1 week apart unless urinary protein < 1.5g in a 24 hr period or urine protein/creatinine ratio < 1.5.
- A history of poorly controlled hypertension or resting blood pressure >150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy (measurements will be made after the patient has been resting supine for a minimum of 5 minutes. Two or more readings should be taken at 2-minute intervals and averaged. If the first two diastolic readings differ by more than 5 mmHg, then an additional reading should be obtained and averaged).
- Blood transfusions within 28 days prior to study start.
- Features suggestive of Myelodysplastic syndrome or Acute myeloid leukemia (MDS/AML) on peripheral blood smear.
- Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. 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 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
- Patients considered at 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 or any psychiatric disorder that prohibits obtaining informed consent.
- Patients unable to swallow medications and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Breast feeding women.
- Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving antiviral therapy.
- Patients with known active hepatic disease (i.e., Hepatitis B or C).
- Patients with a known hypersensitivity to Olaparib, Cediranib or any of the excipients of the products.
- Patients with a known hypersensitivity to Paclitaxel.
- Patients with uncontrolled seizures.
- History of abdominal fistula or gastrointestinal perforation.
- Prior gastrectomy.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Spedali Civili di Brescia
Brescia, BS, 25123
Istituto Eurpeo di Oncologia (IEO)
Milan, 20141
Ospedale San Gerardo - ASST Monza
Monza, MB, 20900
Istituto Oncologico Veneto (IOV)
Padova, PD, 35128
Arcispedale Santa Maria Nuova
Reggio Emilia, RE, 42123
Policlinico Umberto I - Università La Sapienza
Rome, RM, 00161
About this study
Official title: Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib (Continuous vs. Intermittent) in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in platinum refractory or resistant recurrent ovarian cancer.
Patients will be randomised in a 1:1:1 ratio to three treatment arms:
- Arm A: Paclitaxel 80 mg/mq every week
- Arm B: Cediranib 20 mg/day + Olaparib 600 mg / day (i.e. 300 mg BD) given every day
- Arm C: Cediranib 20 mg/day given 5 days per weeks + Olaparib 600 mg / day (i.e. 300 mg BD) given 7 days per weeks
Read the detailed description
Both the experimental arms (Arm B and C) will be compared with Arm A in terms of PFS.
If both superior to the control (Arm A), they will be compared in terms of gastrointestinal safety.
- Conditions
- Ovarian Neoplasms
- Being tested
- Paclitaxel, Cediranib, Olaparib
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called chemotherapy
Comparator active compound
CediranibDrug
Also called tyrosine kinase inhibitor
Experimental compound
OlaparibDrug
Also called Parp inihibitor
Experimental compound
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Intravenous administration of weekly Paclitaxel (dosage: 80 mg/mq) for a maximum of 6 cycles. Cycle is defined as 4 weeks. Receives: Drug: Paclitaxel |
| Arm B | Experimental | Oral administration of two experimental drugs:
* Cediranib 20 mg/day given 7 days per week
* Olaparib 600 mg / day (i.e. 300 mg twice a day) 7 days per week until progression, unacceptable toxicity, patient or physician decision to discontinue or death. Receives: Drug: Cediranib; Drug: Olaparib |
| Arm C | Experimental | Oral administration of two experimental drugs:
* Cediranib 20 mg/day given 5 days per week
* Olaparib 600 mg / day (i.e. 300 mg twice a day) 7 days per week until progression, unacceptable toxicity, patient or physician decision to discontinue or death. Receives: Drug: Cediranib; Drug: Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Progression Free Survival (PFS)
PFS is defined as time from randomization to the date of first progression or death for any cause, whichever comes first.
Progression was established as the radiological disease progression according to RECIST 1.1 (as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions") or to clinical assessment in case radiological evaluation is not feasible due to clinical condition.
Measured: An average of 30 months for each participant
Safety: Number of Evacuations Per Day
Number of evacuations per day used as an index of gastro-intestinal toxicity profile of experimental drugs
Measured: Evacuation were collected daily for the first four weeks of treatment of experimental drugs
Secondary outcomes (12)
Efficacy: Objective Response Rate (ORR)
Percentage of patients with an objective response as determined by RECIST 1.1
Measured: Disease assessments were scheduled every 8 weeks (+/- 1 week) from randomization for all treatment duration (an average of 3.5 months).
Efficacy: PFS2
PFS2 is defined as time from first progression to the date of second progression or death for any cause, whichever comes first.
Measured: Up to one year after the last patient enrolled
Efficacy: Overall Survival (OS)
OS is defined as time from randomization to the date of death for any cause
Measured: Up to one year after the last patient enrolled
Efficacy: Quality of Life
Quality of Life evaluated by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) questionnaire
Measured: Up to sixth month of study treatment
Safety: Maximum Toxicity Grade
Maximum toxicity grade experienced by each patient, for each toxicity, according to NCI-CTCAE v. 4.03
Measured: Up to 30 days after the end of treatment
Safety: Number of Patients Experiencing Grade 3-4 Toxicity for Each Toxicity
Number of patients experiencing grade 3-4 toxicity for each toxicity according to NCI-CTCAE v. 4.03
Measured: Adverse events were collected at the end of each cycle for the duration of treatment for each participant (an average of 3.5 months) and following 30 days after the end of treatment.
Safety: Type, Frequency and Nature of SAEs
Type, frequency and nature of SAEs, according to NCI-CTCAE v. 4.03
Measured: Up to 30 days after the end of treatment
Safety: Number of Patients With at Least a SAE; Patients With at Least a SADR
Number of patients with at least a SAE; patients with at least a SADR, according to NCI-CTCAE v. 4.03
Measured: Up to 30 days after the end of treatment
Safety: Number of Patients With at Least a SUSAR
Number of patients with at least a SUSAR, according to NCI-CTCAE v. 4.03
Measured: Up to 30 days after the end of treatment
Compliance: Number of Administered Cycles
The endpoint for compliance is the number of administered cycles.
Measured: Up to one year after the last patient enrolled
Compliance: Reasons for Discontinuation and Treatment Modification
The endpoints for compliance are the reasons for discontinuation and treatment modification.
Measured: Up to one year after the last patient enrolled
Compliance: Dose Intensity
Entire dose administered during treatment
Measured: Up to one year after the last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start12 Jun 2017
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Roldano Fossati, MD, Study director, Mario Negri Institute for Pharmacological ResearchNicoletta Colombo, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314740
- Sponsor's protocol ID
- IRFMN-OVA-7289
- Acronym
- BAROCCO
- Status last verified
- Nov 2024
- First submitted
- 1 Jun 2017
- Last updated
- 10 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
PubMed 35170751Colombo N, Tomao F, Benedetti Panici P, Nicoletto MO, Tognon G, Bologna A, Lissoni AA, DeCensi A, Lapresa M, Mancari R, Palaia I, Tasca G, Tettamanzi F, Alvisi MF, Rulli E, Poli D, Carlucci L, Torri V, Fossati R, Biagioli E; BAROCCO study group. Randomized phase II trial of weekly paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule) in platinum-resistant high-grade epithelial ovarian cancer. Gynecol Oncol. 2022 Mar;164(3):505-513. doi: 10.1016/j.ygyno.2022.01.015. Epub 2022 Jan 19.
PubMed 35063281
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib (Continuous vs. Intermittent) in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT03314740
- Acronym / sponsor ID
- BAROCCO / IRFMN-OVA-7289
- Conditions
- Ovarian Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Posted 10 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, randomized, multi-centre study aiming at comparing the efficacy of Olaparib and Cediranib vs. weekly Paclitaxel in terms of progression free survival (PFS) in platinum refractory or resistant recurrent ovarian cancer.
Patients will be randomised in a 1:1:1 ratio to three treatment arms:
- Arm A: Paclitaxel 80 mg/mq every week
- Arm B: Cediranib 20 mg/day + Olaparib 600 mg / day (i.e. 300 mg BD) given every day
- Arm C: Cediranib 20 mg/day given 5 days per weeks + Olaparib 600 mg / day (i.e. 300 mg BD) given 7 days per weeks
Detailed description
Both the experimental arms (Arm B and C) will be compared with Arm A in terms of PFS.
If both superior to the control (Arm A), they will be compared in terms of gastrointestinal safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: PaclitaxelIntravenous administration of weekly Paclitaxel (dosage: 80 mg/mq) for a maximum of 6 cycles. Cycle is defined as 4 weeks. |
| Arm B | Experimental | Drug: Cediranib, Drug: OlaparibOral administration of two experimental drugs: * Cediranib 20 mg/day given 7 days per week * Olaparib 600 mg / day (i.e. 300 mg twice a day) 7 days per week until progression, unacceptable toxicity, patient or physician decision to discontinue or death. |
| Arm C | Experimental | Drug: Cediranib, Drug: OlaparibOral administration of two experimental drugs: * Cediranib 20 mg/day given 5 days per week * Olaparib 600 mg / day (i.e. 300 mg twice a day) 7 days per week until progression, unacceptable toxicity, patient or physician decision to discontinue or death. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Patients affected by pathologically confirmed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Relapsed/progressive disease within 6 months from last platinum-based chemotherapy (platinum resistant/refractory disease).
- Any line of treatment (after the first).
- Any "last" chemotherapy line, including Paclitaxel, that should have been administered at least 6 months before the study beginning.
- Patients must be women > 18 years of age.
Key exclusion criteria (25 listed)
- Any previous treatment with a PARP inhibitor, including Olaparib.
- Prior treatment with Cediranib (previous bevacizumab or other antiangiogenic drugs are allowed)
- Previous progression to weekly Paclitaxel
- Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years
- Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug.
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 |
|---|---|---|
| PaclitaxelAlso: chemotherapyComparator active compound | Drug | Arm A |
| CediranibAlso: tyrosine kinase inhibitorExperimental compound | Drug | Arm B, Arm C |
| OlaparibAlso: Parp inihibitorExperimental compound | Drug | Arm B, Arm C |
Primary outcome
Efficacy: Progression Free Survival (PFS)
Time frame: An average of 30 months for each participant
PFS is defined as time from randomization to the date of first progression or death for any cause, whichever comes first. Progression was established as the radiological disease progression according to RECIST 1.1 (as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions") or to clinical assessment in case radiological evaluation is not feasible due to clinical condition.
Safety: Number of Evacuations Per Day
Time frame: Evacuation were collected daily for the first four weeks of treatment of experimental drugs
Number of evacuations per day used as an index of gastro-intestinal toxicity profile of experimental drugs
12 secondary outcomes
Efficacy: Objective Response Rate (ORR)
Time frame: Disease assessments were scheduled every 8 weeks (+/- 1 week) from randomization for all treatment duration (an average of 3.5 months).
Efficacy: PFS2
Time frame: Up to one year after the last patient enrolled
Efficacy: Overall Survival (OS)
Time frame: Up to one year after the last patient enrolled
Efficacy: Quality of Life
Time frame: Up to sixth month of study treatment
Safety: Maximum Toxicity Grade
Time frame: Up to 30 days after the end of treatment
Safety: Number of Patients Experiencing Grade 3-4 Toxicity for Each Toxicity
Time frame: Adverse events were collected at the end of each cycle for the duration of treatment for each participant (an average of 3.5 months) and following 30 days after the end of treatment.
Safety: Type, Frequency and Nature of SAEs
Time frame: Up to 30 days after the end of treatment
Safety: Number of Patients With at Least a SAE; Patients With at Least a SADR
Time frame: Up to 30 days after the end of treatment
Safety: Number of Patients With at Least a SUSAR
Time frame: Up to 30 days after the end of treatment
Compliance: Number of Administered Cycles
Time frame: Up to one year after the last patient enrolled
Compliance: Reasons for Discontinuation and Treatment Modification
Time frame: Up to one year after the last patient enrolled
Compliance: Dose Intensity
Time frame: Up to one year after the last patient enrolled
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35170751Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
- Derived from this study: PubMed 35063281Colombo N, Tomao F, Benedetti Panici P, Nicoletto MO, Tognon G, Bologna A, Lissoni AA, DeCensi A, Lapresa M, Mancari R, Palaia I, Tasca G, Tettamanzi F, Alvisi MF, Rulli E, Poli D, Carlucci L, Torri V, Fossati R, Biagioli E; BAROCCO study group. Randomized phase II trial of weekly paclitaxel vs. cediranib-olaparib (continuous or intermittent schedule) in platinum-resistant high-grade epithelial ovarian cancer. Gynecol Oncol. 2022 Mar;164(3):505-513. doi: 10.1016/j.ygyno.2022.01.015. Epub 2022 Jan 19.
Related trials for Ovarian Neoplasms
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
Roldano Fossati, MD study director
Mario Negri Institute for Pharmacological Research
Nicoletta Colombo, MD principal investigator
European Institute of Oncology
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Cediranib and Olaparib in people with Ovarian Neoplasms, run by Mario Negri Institute for Pharmacological Research at 6 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 24 inclusion and 25 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 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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?
Yes. Results are posted in the registry (first posted 10 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy: Progression Free Survival (PFS) (time frame: An average of 30 months for each participant). The study lists 2 primary outcomes in all. 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 NCT03314740, 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 10 Jan 2025.