AzTrials
AzTrials

Endometrial CarcinomaPhase 2UTOLANCT03745950

UTOLA: UTerin OLAparib

A Phase 2 study testing Olaparib Oral Capsule in people with Endometrial Carcinoma, run by ARCAGY/ GINECO GROUP at 36 sites in France.

Completed

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

Official record
Search all trials

Trial summary

This is a phase IIB, national, randomized, double-blinded, comparative, multi-center study, to assess the efficacy of Olaparib as maintenance after a platinum based chemotherapy in patients with Advanced or metastatic endometrial cancer Read more about this study

Who is it for?
Ages 18 to 95 years, women only
Conditions the study is for
Endometrial Carcinoma
What is being tested?
Olaparib Oral Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
147 participants
Where
36 sitesFrance
Study dates
1 Feb 2019to 24 Sep 2024
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 18 to 95 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female Patient ≥18 years at the day of consenting to the study
  • Provision of informed consent prior to any study specific procedures
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status < 2
  • Patient with advanced/metastatic endometrial cancer not candidate to a curative treatment with surgery or radiotherapy
  • Patients who have completed prior to randomization one Platine based chemotherapy for advanced disease after 6 cycles of chemotherapy (at least 4 cycles of platine). Patients must have a measurable disease according RECIST 1-1 at the initiation of the chemotherapy (cf. appendix 3)
  • Patients must be prior to randomization without evidence of disease (NED) or in complete response (CR) or partial response (PR) or stable disease from the chemotherapy
Show all 25Show fewer
  • Patient should have been tested biolology for IHC : P53 and MMR within two weeks before the randomisation and (NGS; BRCA/HRD) within 3 months after the randomisation
  • Patients could have been previously treated with Hormone-therapy
  • Adjuvant chemotherapy or local radio-chemotherapy is allowed (with a delay of at least of 12 months). First recurrence at least 12 months after a loco-regional treatment.
  • Patients pay have received external beam +/- vaginal brachytherapy
  • All histologic and molecular subtypes of endometrial carcinoma will be included (including mixte histology), except carcinosarcoma, neuro-endocrine and small cells carcinoma.
  • Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
  • Haemoglobin ≥10.0 g/dL with no blood transfusion in the past 28 days
  • 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)
  • Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) ≤2.5 x institutional upper limit of normal unless liver metastases are present in which case they must be ≤5x ULN
  • Patients must have creatinine clearance estimated using the Cockcroft-Gault equation of ≥51 mL/min:
  • Recovery from all reversible adverse events of previous anti-cancer therapies to baseline or CTCAE G 1, except for alopecia (any grade) and ≤ G 2 sensory peripheral neuropathy
  • Able to swallow and retain oral drug
  • Postmenopausal or evidence of non-childbearing status for women of childbearing potential prior to the first dose of study treatment. (negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1. Postmenopausal is defined as: Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments/Luteinizing hormone (LH) and Follicle stimulating hormone (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 sterilisation (bilateral oophorectomy or hysterectomy)"
  • Life expectancy > 16 weeks
  • Patients is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
  • As this study will include patients in France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category.
  • For inclusion in ancillary studies If a patient declines to participate in the optional Biomarker/pharmacogenetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study.

Who cannot join

  • Patients with carcinosarcoma, neuro-endocrine and small cells histologies
  • Patients who have previously received more than 1 line of chemotherapy for advanced/metastatic endometrial cancer
  • Patients with a localized advanced disease that could be treated by surgery
  • Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS)
  • Patients with myelodysplastic syndrome/acute myeloid leukemia history or with features suggestive of MDS/AML.
  • Patients receiving radiotherapy within 6 weeks prior to study treatment.
Show all 25Show fewer
  • Major surgery within 4 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.
  • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
  • Any previous treatment with PARP inhibitor, including olaparib.
  • Clinically significant (e.g. active) cardiovascular disease, uncontrolled high blood pressure
  • Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub- Arachnoids Hemorrhage (SAH) within 6 months prior to randomization.
  • History or evidence of hemorrhagic disorders within 6 months prior to randomization
  • Resting ECG with QTc > 470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
  • 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.
  • 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 (Common Terminology Criteria for Adverse Event (CTCAE) > grade 2) caused by previous cancer therapy, excluding alopecia.
  • 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 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
  • 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, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
  • Pregnant or lactating woman
  • Participation in another clinical study with an investigational product during he chemotherapy course immediately prior to randomization.
  • Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
  • Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
  • Patients with known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
  • Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

France36 sites

  • ICO Paul Papin

    Angers

  • Institut du cancer Avignon-Provence

    Avignon

  • CHRU Jean Minjoz

    Besançon

  • Institut Bergonié

    Bordeaux

  • Centre François Baclesse

    Caen

  • Centre Jean Perrin

    Clermont-Ferrand

  • Centre Hospitalier Intercommunal de Créteil

    Créteil

  • Chu Dijon

    Dijon, 21000

  • Centre Georges François Leclerc

    Dijon

  • Institut Daniel Hollard - GHM de Grenoble

    Grenoble

  • Institut inter-régionaL de Cancérologie - Centre Jean Bernard - Clinique Victor Hugo

    Le Mans

  • Centre Oscar Lambret

    Lille

  • Centre Léon Bérard

    Lyon

  • Hôpital Saint-Joseph

    Marseille

  • Centre Hospitalier de Mont-De-Marsan

    Mont-de-Marsan

  • ICM Val d'Aurelle

    Montpellier

  • Centre Azuréen de Cancérologie

    Mougins

  • Centre d'Oncologie de Gentilly

    Nancy

  • Hôpital Privé du Confluent SAS

    Nantes

  • Centre Antoine Lacassagne

    Nice

  • Institut de Cancérologie du Gard - CHU de Nîmes

    Nîmes

  • CHR d'Orléans

    Orléans

  • Groupe Hospitalier Diaconesses Croix Saint-Simon

    Paris

  • Hôpital Cochin

    Paris

  • Institut Curie - Hopital Claudius Régaud

    Paris

  • Polyclinique Francheville

    Périgueux

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite

  • Centre CARIO - HPCA

    Plérin

  • CHU de Poitiers - Hôpital de la Milétrie

    Poitiers

  • Centre Henri Becquerel

    Rouen

  • ICO Centre René Gauducheau

    Saint-Herblain

  • CHU Saint Etienne - Pôle de Cancérologie

    Saint-Priest-en-Jarez

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg

  • Institut Claudius Régaud

    Toulouse

  • Institut de Cancérologie de Lorraine - Centre Alexis Vautrin

    Vandœuvre-lès-Nancy

  • Gustave Roussy

    Villejuif

Other trials in France

About this study

Official title: Multicenter Double Blind Randomized Phase II Trial of Olaparib vs Placebo as Maintenance Therapy in Platinum-sensitive Advanced Endometrial Carcinoma

This is a phase IIB, national, randomized, double-blinded, comparative, multi-center study, to assess the efficacy of Olaparib as maintenance after a platinum based chemotherapy in patients with Advanced or metastatic endometrial cancer

Read the detailed description

Approximately 147 patients will be randomized using an Interactive Voice Response System / Interactive web system (IVR/IWR system) in a 2:1 ratio to the treatments as specified below :

  • Olaparib tablets per os 300 mg twice daily,
  • Placebo tablets per os 300 mg twice daily.

Before randomization to the study :

  • Patient should be without evidence of disease (NED), or in clinical complete response or in partial response or stable.
  • Patient must have completed a minimum of 4 cycles of first line platinum based chemotherapy (recommended chemotherapy is carboplatine AUC 5 plus paclitaxel 175 mg/m2).

Patient will be stratified according to :

  • P53 and MMR Immunohistochemistry, (Y/N)
  • Response to previous chemotherapy line (Objective response versus Stable)

Patients will receive Olaparib/Placebo up to disease progression.

Being tested
Olaparib Oral Capsule, Placebo oral capsule
Keywords
Maintenance therapy, Olaparib, Randomized, double blinded, P53 and MMR Immunohistochemistry, Phase II, progression-free survival
Medical subject headings
Endometrial Neoplasms

What participants receive

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

  • Olaparib Oral CapsuleDrug

    • Olaparib will be administrated by oral at dose of 300 mg twice daily during the induction period and in maintenance

  • Placebo oral capsuleDrug

    • Placebo will be administrated by oral at dose of 300 mg twice daily during the induction period and in maintenance
Study groups in NCT03745950
Study groupRoleWhat they receive
OlaparibExperimentalThe Olaparib arm : Patients will be administrated the randomized study treatment tablets orally at a dose of 300 mg twice daily until objective radiological disease progression as per RECIST (Response evaluation criteria in solid tumors) as assessed by the investigator, or unacceptable toxicity
Receives: Drug: Olaparib Oral Capsule
PlaceboPlacebo comparatorThe placebo arm : Patients will be administrated the randomized study treatment tablets orally at a dose of 300 mg twice daily until objective radiological disease progression as per RECIST as assessed by the investigator, or unacceptable toxicity
Receives: Drug: Placebo oral capsule

What is being measured

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

  1. Efficacy: Progression free survival (PFS1) according to modified Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) of Olaparib maintenance after a platinum based chemotherapy in patients with advanced or metastatic endometrial cancer

    Measured: An average of 36 months

Secondary outcomes (14)

  1. To determine time from randomization until death from any cause

    Measured: To be assessed around 73 months

  2. To determine time from randomization to efficacy by progression free survival

    Measured: To be assessed around 36 months

  3. To determine time from response rate according to IHC P53, MMR, NGS BRCA/HRD, MSI

    Measured: To be assessed around 36 months

  4. To determine the overall response rate ORR

    Measured: To be assessed around 30 months

  5. To determine time from randomization to first and second subsequent therapy (TFST, TSST)

    Measured: To be assessed around 36 months

  6. To determine time from randomization until 2nd disease progression or death (PFS2)

    Measured: To be assessed around 73 months

  7. To assess the safety of Olaparib maintenance compared to placebo - Graded according to CTCAE version 4.03.

    Graded according to CTCAE version 4.03. These will be collected by all patients.

    Measured: To be assessed around 36 months

  8. To assess the tolerability of Olaparib maintenance compared to placebo - Graded according to CTCAE version 4.03.

    Graded according to CTCAE (Common Terminology Criteria for Adverse Events) version 4.03. These will be collected by all patients.

    Measured: To be assessed around 36 months

  9. To assess the effects of Olaparib on health-related quality of life (HRQoL) as measure by determining time to deterioration in Quality of life, based on EORTC QLQ-C30 (Quality Of Life Questionnaire-core 30)

    Health related quality of life of the patient. For all scales a high score is equivalent to worse or more problems. Range is the difference between the maximum and minimum possible value of the raw score. All items are scored from1 to 4, giving a range=3. For each scale, calculate the raw score by the addition of item responses divided by the number of items. Then a linear transformation is used to standardise the raw score, so that scores range from 0 to 100. Score= (raw score-1)/rangex100

    Measured: to be assessed 36 months

  10. To assess the effects of Olaparib on health-related quality of life (HRQoL) as measure by determining time to deterioration in Quality of life, based EORTC QLQ-EN24 (Quality of Life Questionnaire - Endometrial Cancer Module)

    To assess disease and treatment specific aspects of the quality of life of patients with endometrial cancer. A high score for the functional scales represents a high level of functioning, while a high score for the symptom scales represents a high level of symptoms or problems. Symptoms related to sexual/vaginal problems (EMSXV including item 51-53) are optional.

    Measured: to be assessed 36 months

  11. To assess the effects of Olaparib on health-related quality of life (HRQoL) as measure by determining time to deterioration in Quality of life, based on EORTC FA12 (Quality of life Module Measuring Cancer Related Fatigue)

    To assess physical, cognitive and emotional aspects of cancer-related fatigue.The higher the score, the better the QOL

    Measured: to be assessed 36 months

  12. To assess the effects of Olaparib on health-related quality of life (HRQoL) as measure by determining time to deterioration in Quality of life, based on Quality of Life Questionnaire EQ5D (consists of a descriptive system and the EQ VAS)

    EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. The maximum score of 1 indicates the best health state, by contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.

    Measured: to be assessed 36 months

  13. To determine efficacy by progression free survival

    PFS1 is defined as the time from randomization until the date of the first objective radiological disease progression according to investigator assessment

    Measured: To be assessed around 73 months

  14. To determine response rate according to response to the initial chemotherapy

    Measured: To be assessed around 73 months

Timeline

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

  1. First posted19 Nov 2018
  2. Study start1 Feb 2019
  3. Primary completion22 May 2023
  4. Study completion24 Sep 2024

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
Olaparib vs placebo
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03745950
Sponsor's protocol ID
GINECO-EN-104b
Acronym
UTOLA
Status last verified
Dec 2024
First submitted
31 Oct 2018
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Beinse G, Leroy K, Just PA, Jeanne C, Cherifi F, Leary A, Le Saux O, You B, Rodrigues M, Gladieff L, Abadie-Lacourtoisie S, Lefevre LB, Brachet PE, Lebreton C, Meynard G, Fournel P, Frenel JS, Selle F, Largillier R, Foa C, Cornila C, Fernandez Diez Y, Bonnet E, Arnaud A, Kaczmarek E, Follana P, Bouchaert P, Joly F, Alexandre J, Leman R. Association between molecular classification and overall survival in patients with metastatic endometrial carcinoma: ancillary results of the UTOLA phase II GINECO trial. Int J Gynecol Cancer. 2026 Feb;36(2):102829. doi: 10.1016/j.ijgc.2025.102829. Epub 2025 Nov 21.

    PubMed 41418627

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olaparib Oral Capsule in people with Endometrial Carcinoma, run by ARCAGY/ GINECO GROUP at 36 sites in France.

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 25 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 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in France. 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 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?

Efficacy: Progression free survival (PFS1) according to modified Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) of Olaparib maintenance after a platinum based chemotherapy in patients with advanced or metastatic endometrial cancer (time frame: An average of 36 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 NCT03745950, which also lists 1 linked publication.

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 4 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in