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Ovarian CancerPhase 1/2REVOCANNCT04826198

Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to PARP Inhibitors in Patients With Relapsed Platinum Sensitive Ovarian Cancer Already Treated With PARP Inhibitors Since at Least 6 Months

A Phase 1/2 study testing AsiDNA, Niraparib and Olaparib in people with Ovarian Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 6 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The objective of REVOCAN study is to assess the abrogation of PARP inhibitors resistance in patients with relapsed platinum sensitive ovarian cancer treated with PARP inhibitors in maintenance since at least 6 months and who have only an increase of CA 125 without any progression according to RECIST criteria. 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?
AsiDNA, Niraparib and Olaparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
6 sitesFrance
Study dates
5 Oct 2020to 4 Apr 2024
Phase
Phase 1/2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
  • Female aged ≥ 18 years (no upper limit of age) at the time of consent signature.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy of at least 3 months.
  • Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer regardless BRCA status.
  • Availability of BRCA status;
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  • Patient has received at least 2 previous courses of platinum-containing therapy and has a disease that was considered platinum sensitive that means in response (complete or partial) to the last platinum course leading to the administration of Niraparib, or Rucaparib, or Olaparib (PARP inhibitors).
  • The patient has received Niraparib in maintenance for at least 6 months and who has only an increase of CA125 at least twice the upper limit of normal within 2 weeks prior to starting treatment without any progression according to RECIST criteria or according to clinical assessment
  • Patient should be treated within 2 weeks after CT scan without any progression according to RECIST criteria
  • Patient with adequate biological parameters at baseline defined as:
  • absolute neutrophil count (ANC) ≥ 1.5 x 109/L,
  • hemoglobin (Hb) level ≥ 9g/dL,
  • platelet count ≥ 100 x 109/L,
  • total bilirubin level ≤ 1.5 Upper Limit Normal (ULN),
  • aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5x ULN
  • calculated glomerular filtration rate (GFR) ≥ 60 mL/min/1.73m2 (per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula),
  • INR ≤ 1.2 (except if patient treated with anti-vitamine K); anticoagulation with anti-vitamin K and Low Molecular Weight Heparin [LMWH] is allowed.
  • Patient of childbearing potential must agree to use adequate contraception prior to study entry, during the study and for 3 months after the study participation
  • Patient of childbearing potential must have a serum negative pregnancy test within 4 days prior to first administration. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test.
  • Patient must be affiliated to a social security system or an equivalent system.

Who cannot join

  • Patient has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer
  • Patient treated concomitantly with bevacizumab
  • Patient previously treated with PARPi as first line maintenance
  • Other Malignancy within the last 5 years except curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix, and in situ breast cancer
  • Patient with central nervous system (CNS) metastases;
  • Other tumor location necessitating an urgent therapeutic intervention (e.g., palliative care, surgery or radiation therapy, such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture).
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  • Patient with uncontrolled disease-related metabolic disorder (e.g., hypercalcemia, SIADH) or uncontrolled diabetes.
  • Quantitative total urine protein > 1.0 g/24 hour at baseline
  • Patient with uncontrolled congestive heart failure defined as New York Heart Association (NYHA) class III or IV, uncontrolled hypertension, unstable heart disease (e.g., coronary artery disease with unstable angina or myocardial infarction within 6 months before study treatment administration).
  • Patient with significant ECG abnormalities defined as any cardiac dysrhythmia (> grade 2) (i.e., significant ventricular arrhythmia as persistent ventricular tachycardia and/or ventricular fibrillation; severe conduction disorders as atrio-ventricular block 2 and 3, sino-atrial block) or baseline QT/QTc interval >480 milliseconds (ms).
  • Patient with significant chronic liver disease (e.g., significant fibrosis,known cirrhosis) or active HBV or HCV infection; if AgHbs positive, an effective antiviral treatment to prevent hepatitis B reactivation is recommended.
  • Patient with HIV infection or an active infection requiring specific antiinfective therapy are not eligible until all signs of infection have resolved, and this within 2 weeks prior to the first study treatment administration.
  • Patient whose medical, psychological including alcohol or drug abuse, or surgical conditions are unstable and may affect the study completion and/or compliance and/or the ability to give informed consent.
  • Participation in another clinical trial with any investigational drug within 28 days prior to first study drug administration.
  • Vulnerable adult patients benefiting from a specific legal protection status.
  • Patient who has received mouse antibodies (unless the assay used has been shown not to be influenced by HAMA4,5) or if there has been medical and/or surgical interference with their peritoneum or pleura during previous 28 days
  • Patient pregnant or breastfeeding

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • CHU Jean Minjoz

    Besançon, Besancon, 25000

  • Institut Bergonié

    Bordeaux, 33076

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hospices civils de Lyon(CHU Lyon Sud)

    Pierre-Bénite, Lyon, 69310

  • Institut de Cancérologie de l'Ouest - St Herblain

    Saint-Herblain, Nantes, 44805

  • Gustave Roussy

    Villejuif, Val De Marne, 94800

Other trials in France

About this study

Official title: An Open-label, Multicentric, Phase Ib/II Study to Assess the Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to Niraparib in Patients With Relapsed Platinum Sensitive Ovarian Cancer Already Treated With Niraparib Since at Least 6 Months

The objective of REVOCAN study is to assess the abrogation of PARP inhibitors resistance in patients with relapsed platinum sensitive ovarian cancer treated with PARP inhibitors in maintenance since at least 6 months and who have only an increase of CA 125 without any progression according to RECIST criteria. AsiDNATM at 600 mg will be tested in addition to PARP inhibitors given according to the label in REVOCAN study.

Conditions
Ovarian Cancer
Being tested
AsiDNA, Niraparib, Olaparib, Rucaparib
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • AsiDNADrug

    Unit dose: Vial containing 100 mg of AsiDNA™ (free acid) Regimen: 3 consecutive infusions (D1, D2, D3) followed by a once a week iv infusion on D8 and D15 of a 21 day-treatment cycle at first cycle, then weekly iv infusion in the absence of disease progression or unacceptable toxicity Mode/route: 1 hour intravenous (iv) infusion

  • NiraparibDrug

    Unit dose: Hard capsule containing 100mg of Niraparib Regimen: The last dose given during the 6 previous months of Niraparib 200 mg/day or 300 mg/day, (or 100 mg/day only if the patient has received this dose since at least 6 months) Daily, 1, 2 or 3 hard capsules at 100mg once daily at approximately the same time each day.

    Mode/route: Per os

  • OlaparibDrug

    Product name: Olaparib Pharmaceutical form: Tablets containing 100 or 150mg of Olaparib Route of administration: per os Dose Regimen: The last dose given during the 6 previous months of Olaparib 600 mg/day or 500 mg/day, (or 400 mg/day only if the patient has received this dose since at least 6 months) Two times daily (300mg or 250 mg or 200mg) at approximately the same time each day.

  • RucaparibDrug

    Product name: Rucaparib Pharmaceutical form: Tablets containing 200 or 250 or 300mg of Rucaparib Route of administration: per os Dose Regimen: The last dose given during the 6 previous months of Rucaparib 1200 mg/day or 1000 mg/day, or 800mg/day (or 600 mg/day only if the patient has received this dose since at least 6 months) Two times daily (600mg or 500mg or 400mg or 300mg) at approximately the same time each day.

Study groups in NCT04826198
Study groupRoleWhat they receive
AsiDNA in addition to NiraparibExperimentalPart A: AsiDN in addition to Niraparib (Safety evaluation) Part B: AsiDN in addition to Niraparib (Efficacy evaluation and Safety confirmation )
Receives: Drug: AsiDNA; Drug: Niraparib; Drug: Olaparib; Drug: Rucaparib

What is being measured

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

  1. Dose limiting toxicities (DLT)

    Occurrence of cases of Dose Limiting Toxicity (DLT) will be recorded and reviewed according to a predefined definition.

    DLTs include the following specific treatment-related AEs occurring during the first 21 days (from D1 to D21) treatment period (based on the National Cancer

    Institute [NCI] Common Terminology Criteria for Adverse Events (AE) [CTCAE] scale, version 5.0 defined as:

    • Haematological toxicity:
    1. Grade 4 neutropenia lasting ≥ 7 days,
    2. Febrile Neutropenia,
    3. Grade 4 thrombocytopenia or grade 3 thrombocytopenia associated with bleeding.
    • Non haematological toxicity:

    Any drug-related non-hematological toxicity grade ≥ 3 toxicity (except alopecia, fatigue, nausea, controlled hypertension and vomiting adequately treated with antiemetic treatment and non-clinically significant laboratory values abnormalities).

    Measured: 21 days

Timeline

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

  1. First posted1 Apr 2021
  2. Study start5 Oct 2020
  3. Primary completion4 Apr 2024
  4. Study completion4 Apr 2024

Why it stopped: Treatment availability issue: The manufacturer of AsiDNA™ decided to cease production to develop an improved version, and the contract ensuring access to this molecule has expired.

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multicenter, open label, phase Ib/II
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04826198
Sponsor's protocol ID
2020-000825-18
Other IDs
2020-3047
Acronym
REVOCAN
Status last verified
Dec 2024
First submitted
23 Feb 2021
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AsiDNA, Niraparib and Olaparib in people with Ovarian Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 6 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 20 inclusion and 17 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 5 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 6 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was stopped early (reason given: Treatment availability issue: The manufacturer of AsiDNA™ decided to cease production to develop an improved version, and the contract ensuring access to this molecule has expired.). 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?

Dose limiting toxicities (DLT) (time frame: 21 days). 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 NCT04826198.

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 5 Dec 2024.

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