Informations générales (source: ClinicalTrials.gov)
A Phase 2 Open-Label, Multicenter Study To Evaluate Efficacy And Safety Of ZN-c3 In Subjects With High-Grade Serous Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer (DENALI / ZN-c3-005 / GOG-3066)
Interventional
Phase 2
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc (Voir sur ClinicalTrials)
février 2022
juin 2027
13 septembre 2025
This is a multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib
(ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube,
or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose
tumors are Cyclin E1 positive as determined by central review using the Sponsor's
investigational clinical trial assay.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alexandra LEARY | 17/06/2024 10:53:15 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Site 3602 - Centre Oscar Lambret - 59000 - Lille - Nord - France | Contact (sur clinicalTrials) | ||||
| Site 3608 - Hospices Civils de Lyon - Hôpital Lyon Sud - 69310 - Pierre-Bénite - Rhône - France | Benoit You | Contact (sur clinicalTrials) | |||
| Site 3611 - ICANS - Institut de cancérologie Strasbourg Europe - 67200 - Strasbourg - Bas-Rhin - France | Contact (sur clinicalTrials) | ||||
| Site 3613 - Hopital Jean Minjoz - 25030 - Besançon - Doubs - France | Contact (sur clinicalTrials) | ||||
| Site 3614 - Institut de Cancerologie de l'oust - 44800 - Saint-Herblain - Pays De La Loire - France | Jean-Sébastien Frénel | Contact (sur clinicalTrials) | |||
| Site 3616 - Centre Antoine Lacassagne - 06100 - Nice - Alpes-Maritimes - France | Philippe Follana | Contact (sur clinicalTrials) | |||
| Site 3617 - CHU de Brest - Hôpital La Cavale Blanche - 29200 - Brest - Finistere - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
Inclusion Criteria:
1. Age ≥18 years
2. High-grade serous ovarian, fallopian tube or primary peritoneal cancer
3. Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status
result determined by IHC using the Sponsor's investigational clinical trial assay
4. Prior therapy:
1. Subjects must have platinum-resistant disease
2. One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted,
if prior mirvetuximab)
3. Prior bevacizumab treatment is required, if eligible per standard of care
4. Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if
eligible per standard of care
5. Prior mirvetuximab treatment is required, if eligible per standard of care
5. Measurable disease per RECIST Version 1.1.
6. Adequate hematologic and organ function, as defined in protocol
7. ECOG 0-1
1. Age ≥18 years
2. High-grade serous ovarian, fallopian tube or primary peritoneal cancer
3. Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status
result determined by IHC using the Sponsor's investigational clinical trial assay
4. Prior therapy:
1. Subjects must have platinum-resistant disease
2. One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted,
if prior mirvetuximab)
3. Prior bevacizumab treatment is required, if eligible per standard of care
4. Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if
eligible per standard of care
5. Prior mirvetuximab treatment is required, if eligible per standard of care
5. Measurable disease per RECIST Version 1.1.
6. Adequate hematologic and organ function, as defined in protocol
7. ECOG 0-1
1. Primary platinum-refractory disease
2. Any of the following treatment interventions within the specified time frame prior
to C1D1:
1. Major surgery within 28 days
2. Hospitalization within 14 days
3. Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives
(whichever is shorter);
4. Radiation therapy within 21 days;
5. Autologous or allogeneic stem cell transplant within 3 months.
6. Current use of any other investigational drug therapy <28 days or 5 half-lives
(whichever is shorter).
7. Inability to discontinue treatment prescription or non-prescription drugs, or
to discontinue consumption of food and herbal supplements that are strong or
moderate CYP3A inhibitors and inducers or P-gp inhibitors at least 14 days
prior to C1D1.
3. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1
inhibitor, or CHK1/2 inhibitor.
4. A serious illness or medical condition(s) including, but not limited to:
1. Clinically or radiographically unstable brain metastases or leptomeningeal
disease that requires immediate treatment. Subjects with asymptomatic brain
metastases are eligible.
2. Myocardial impairment resulting in heart failure (NYHA Class II-IV)
3. Severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase risk associated with study participation or may
interfere with interpretation of study results
4. Acute kidney injury requiring intervention or intravenous fluid in the last 14
days or presence of indwelling urinary catheter or percutaneous nephrostomy.
5. Significant gastrointestinal abnormalities, including an inability to take oral
medication, requirement for intravenous alimentation, active peptic ulcer,
chronic diarrhea or vomiting considered to be clinically significant in the
judgment of the Investigator, or prior surgical procedures affecting
absorption.
6. Active, uncontrolled infection. Subjects with an infection receiving treatment
(antibiotic, antifungal, or antiviral) must have completed such treatment and
the infection must be considered controlled/resolved (and afebrile) by the
Investigator for at least 7 days before C1D1
7. Any evidence of bowel obstruction as determined by air/fluid levels on computed
tomography (CT scan, recent hospitalization for small bowel obstruction within
3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6
weeks prior to C1D1.
5. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade
≤2 neuropathy, alopecia, or skin pigmentation).
6. Pregnant or lactating female subject or female subject of childbearing potential who
has a positive serum pregnancy test within 14 days prior to C1D1.
7. History of another malignancy in the previous 2 years, unless cured by surgery alone
and continuously disease free. Exceptions include appropriately treated carcinoma in
situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, or other
malignancies with an expected curative outcome.
8. Subjects who are known to be immunocompromised or HIV-positive on highly active
anti-retroviral therapy.
9. Subjects with known active hepatitis B or hepatitis C infection.
10. Individuals who are judged by the Investigator to be unsuitable as study subjects.
11. Subjects who had prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.