Informations générales (source: ClinicalTrials.gov)
A Phase 1/2 Dose-Escalation and Dose-Expansion Study of ZN-c3 in Combination With Niraparib and ZN-c3 Monotherapy in Subjects With Platinum-Resistant Ovarian Cancer
Interventional
Phase 1/Phase 2
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc (Voir sur ClinicalTrials)
janvier 2022
mai 2025
25 juin 2024
This is a Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics
(PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib and of ZN-c3
Monotherapy in subjects with platinum-resistant ovarian cancer.
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 | 27/05/2024 14:02:20 | 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 | |||||
| Centre Georges François Leclerc - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Lyon Sud - Saint-Genis-Laval - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - Lille - France | Contact (sur clinicalTrials) | ||||
| EDOG - Institut Claudius Regaud - Toulouse - France | Contact (sur clinicalTrials) | ||||
| ICANS - Institut de cancérologie Strasbourg Europe - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut Gustave Roussy - Villejuif - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
Inclusion Criteria:
1. Histologically or cytologically confirmed recurrent high grade epithelial ovarian,
primary peritoneal, or fallopian tube cancer with histologic subtypes of serous,
clear cell or endometroid for which there is no known or established treatment
available with curative intent.
2. Subjects must have platinum-resistant disease.
3. Must have evaluable or measurable disease according to RECIST v1.1 criterion:
defined as at least one lesion that can be accurately measured.
4. Adequate hematologic and organ function.
5. Ability and willingness to take oral medication.
6. Subjects must provide formalin-fixed, paraffin-embedded tumor samples available from
the primary or recurrent cancer.
Key
1. Histologically or cytologically confirmed recurrent high grade epithelial ovarian,
primary peritoneal, or fallopian tube cancer with histologic subtypes of serous,
clear cell or endometroid for which there is no known or established treatment
available with curative intent.
2. Subjects must have platinum-resistant disease.
3. Must have evaluable or measurable disease according to RECIST v1.1 criterion:
defined as at least one lesion that can be accurately measured.
4. Adequate hematologic and organ function.
5. Ability and willingness to take oral medication.
6. Subjects must provide formalin-fixed, paraffin-embedded tumor samples available from
the primary or recurrent cancer.
Key
1. Prior therapy directed at the malignant tumor within the last four weeks prior to
Cycle 1 Day 1 (6 weeks for nitrosoureas or mitomycin C).
2. A minimum of 10 days between termination of the prior PARPi and administration of
ZN-c3 and niraparib treatment is required.
3. Any investigational drug therapy <28 days.
4. Prior treatment with a WEE1 inhibitor.
5. Known hypersensitivity to any drugs similar to ZN-c3 and/or niraparib in class or
its excipients.
6. Participant has any known history or current diagnosis of myelodysplastic syndrome
(MDS) or acute myeloid leukemia (AML).
7. Uncontrolled hypertension (Diastolic BP > 90 mmHg or Systolic BP > 140 mmHg).
8. Myocardial impairment of any cause (e.g., cardiomyopathy, ischemic heart disease,
significant valvular dysfunction, hypertensive heart disease, and congestive heart
failure) resulting in heart failure by New York Heart Association Criteria (Class
III or IV).
9. Significant gastrointestinal abnormalities, requirement for IV 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.
10. 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF)
of >480 ms, except for subjects with atrioventricular pacemakers or other conditions
(e.g., right bundle branch block) that render the QT measurement invalid.
11. History or current evidence of congenital or family history of long QT syndrome or
Torsades de Pointes (TdP).
12. Taking medications with a known risk of TdP (according to current information
provided at https://crediblemeds.org).