NCT03025867Approved For Marketing不适用
Expanded Access Protocol for Niraparib in Patients With Recurrent Ovarian Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 发起方
- Tesaro, Inc.
研究概览
简要总结
This is an expanded access program (EAP) for eligible patients with Recurrent Ovarian Cancer.
This program is designed to provide access to niraparib prior to approval by the US Food and Drug Administration (FDA).
To be eligible, patients with Recurrent Ovarian Cancer following a partial (PR) or complete response (CR) to their most recent platinum-based chemotherapy and must have experienced a PR or CR after the penultimate (next to last) platinum-based chemotherapy for at least 6 months without disease progression after this chemotherapy.
详细描述
If a patient qualifies for participation in an ongoing niraparib clinical trial or is already participating in a niraparib clinical trial, she will not be able to participate in the EAP.
Ongoing clinical trials for niraparib include:
- A Phase 3 trial in patients who have received first-line treatment for ovarian cancer (the PRIMA trial, NCT # 02655016)
- A Phase 2 trial in patients who have received multiple lines of treatment for ovarian cancer (the QUADRA trial, NCT # 02354586)
- A Phase 1/2 trial in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. (the TOPACIO trial, NCT # 02657889)
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- •Completion of at least 2 previous courses of platinum-containing chemotherapy.
- •Had a CR or PR with duration of response >/=6 months following penultimate chemotherapy
- •Achieved a partial (PR) or complete (CR) tumor response following completion of the last platinum-containing chemotherapy [minimum of 4 cycles]
- •Patients previously treated with PARP inhibitors are eligible
- •Eastern Cooperative Oncology Group (ECOG, http://ecog-acrin.org/) performance status 0 or 1
- •Adequate organ function [Absolute neutrophil count (ANC) ≥ (greater than or equal to) 1,500/µL; Platelets ≥ (greater than or equal to) 100,000/µL; Hemoglobin ≥ (greater than or equal to) 9 g/dL]
- •Able to take oral medications
- •Women should not be pregnant at the beginning of the treatment and women or childbearing potential should not become pregnant while on niraparib
- •Patient should start treatment with niraparib no later than 12 weeks after completion of final dose of the platinum-containing chemotherapy
排除标准
- •Persistent ≥Grade 2 hematologic toxicity from prior cancer therapy
- •Known hypersensitivity to the components of niraparib
- •Patient is pregnant or breast feeding, or expecting to conceive children within the projected duration of the program treatment
- •Patient has uncontrolled hypertension
研究者
相似试验
No Longer Available
不适用
Expanded Access Program for Participants Who Completed Study 13-601 and Continue to Clinically Benefit From CerdulatinibRelapsed/Refractory Chronic Lymphocytic LeukemiaNon-hodgkin's LymphomaNCT04757259Alexion Pharmaceuticals, Inc.
尚未招募
2 期
The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer PatientsThrombocytopeniaNCT06036966Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University34
Approved For Marketing
不适用
Expanded Access Program for Pirtobrutinib for Participants With B-Cell CancerLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Lymphocytic, SmallLymphoma, Mantle-CellWaldenstrom MacroglobulinemiaRitcher's Transformation, SyndromeNCT05172700Loxo Oncology, Inc.
No Longer Available
不适用
An Expanded Access Program for AM0010 (Pegilodecakin)Colorectal CarcinomaPancreatic CarcinomaNon-small Cell Lung CarcinomaSolid TumorsBreast CancerProstate CancerOvarian CancerMelanomaRenal Cell CarcinomaNCT03554434Eli Lilly and Company
Approved For Marketing
不适用
Expanded Access Program for Tafasitamab (MOR00208) in R/R DLBCLDLBCLNCT04300803MorphoSys AG