EUCTR2022-001816-25-PL进行中（未招募）1 期
A Phase 2 trial of Nirogacestat in Patients with Recurrent Ovarian Granulosa Cell Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Participant must be aged = 18 years of age inclusive
- •2. Participant has histologically confirmed recurrent adult-type granulosa cell tumor of the ovary prior to first dose of study treatment and agrees to provide archival or new tumor tissue.
- •3. Participant must have documented radiological evidence of relapse after at least one systemic therapy that is not amenable to surgery, or radiation and have measurable disease by RECIST v1.1 criteria. Prior systemic therapy is not limited to therapy type nor is any specific prior line of therapy required.
- •4. Participant must have a ECOG performance Grade of 0, 1, or 2 at Screening.
- •5. Participant must have adequate bone marrow, renal and hepatic function as defined by the following Screening laboratory values:
- •a. Absolute neutrophil count (ANC) =1,000 cells/µL;
- •b. Platelets = 75,000/µL;
- •c. Estimated glomerular filtration rate (eGFR) = 60 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Grade = 1).
- •d. Total bilirubin = 1.5 ×ULN (isolated bilirubin > 1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%);
- •e. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase)/alanine
- •aminotransferase (ALT) (serum glutamic pyruvate transaminase) = 2 x ULN; and
- •f. Alkaline phosphatase < 2.5 × ULN.
- •6. Participant can swallow tablets (delivery of nirogacestat via nasogastric tube or gastrostomy tube is not allowed).
- •7. A female participant is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:
- •a. Is not of childbearing potential (WOCBP);
- •b. Is of childbearing potential but is abstinent or using 1 highly effective contraceptive method, as described in Appendix 6 during the treatment period and until 6 months after the last dose of study treatment. A second method of contraception is required if the participant is using hormonal contraception, as coadministration with nirogacestat may alter the plasma concentrations of hormonal contraceptives resulting in reduced efficacy.
- •Additionally, the participant agrees not to harvest or donate eggs (ova, oocytes) for the purpose of reproduction during the treatment period and for at least 6 months after the last dose of study treatment. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment.
- •A WOCBP must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result at Baseline (C1D1) prior to the first dose of study treatment.
- •Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Participant has any of the following:
- •Signs of bowel obstruction who require parenteral nutrition.
- •Malabsorption syndrome or preexisting gastrointestinal conditions that may impair absorption of nirogacestat (e.g., gastric bypass, lap band, or other gastric procedures that would alter absorption).
- •Participant has experienced any of the following within 6 months of signing informed consent:
- •Clinically significant cardiac disease (New York Heart Association Class III or IV);
- •Myocardial infarction;
- •Severe/unstable angina;
- •Coronary/peripheral artery bypass graft;
- •Symptomatic congestive heart failure;
- •Cerebrovascular accident;
- •Transient ischemic attack; or
- •Symptomatic pulmonary embolism.
- •3. Participant has abnormal QT interval corrected by Fridericia’s formula (> 470 msec for female participants, or > 480 msec for participants with bundle branch block) after electrolytes have been corrected at Screening.
- •4. Participant has congenital or acquired long QT syndrome or a history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- •5. Participant has current or chronic history of liver disease or known hepatic or biliary abnormalities (except for Gilbert’s syndrome or asymptomatic gallstones).
- •6. Participant has had a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to the first dose of study treatment.
- •7. Participant has a history of other invasive malignancies, with the exception of nonmelanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last 5 years. Participants are also excluded if their previous cancer treatment contraindicates this protocol therapy.
- •8. Participant has CTCAE v5.0 Grade > 1 toxicity from prior therapy (except alopecia, anorexia or CTCAE grade 2 peripheral neuropathy).
- •9. Palliative radiotherapy with a limited field of radiation within 14 days or with wide field of radiation or to more than 30% of bone marrow within 28 days prior to the first dose of study treatment.
- •10. Participant previously received or is currently receiving therapy with GS inhibitors (i.e., nirogacestat) or anti-Notch antibody therapy.
- •11. Participant has received any treatment for OvGCT including but not limited to the following within 28 days (or 5 half-lives, whichever is longer) prior to the first dose of study treatment:
- •anti-angiogenic therapy;
- •hormonal therapy;
- •chemotherapy;
- •immunotherapy;
- •targeted therapy (i.e., tyrosine kinase inhibitors [TKIs], small molecule inhibitors, etc.); or
- •any investigational treatment.
- •12. Participant is currently using or anticipates using food or drugs that are known strong/moderate cytochrome P450 3A4 (CYP3A4) inhibitors, or strong CYP3A inducers within 14 days prior to the first dose of study treatment.
- •13. Participant is using concomitant medications that are known to prolong the QT/QTcF interval including Class Ia (e.g., quinidine, procainamide, disopromide) and Class III (e.g., dofetilide, ibutilide, sotalol) antiarrhythmics at the time of informed consent.
- •Non-antiarrhythmic medications which may prolong the QT/QTcF interval are allowed provided the participant does not have additional risk factors for Torsades de Pointes (TdP).
研究者
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