Topics

A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy

2020-01-18 10:35:30 | BioPortfolio

Summary

This is a multicenter, randomized, blinded, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Placebo, as maintenance treatment, in patients with Stage III or IV ovarian cancer. Patients must have completed first-line platinum based regimen with Complete Response (CR) or Partial Response (PR). The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.

Study Design

Conditions

Maintenance Treatment in Patients With Advanced Ovarian Cancer Who Are in Complete or Partial Response to First-line Platinum-based Chemotherapy

Intervention

Fluzoparib; Apatinib, Fluzoparib, Placebo

Status

Not yet recruiting

Source

Jiangsu HengRui Medicine Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-01-18T10:35:30-0500

Clinical Trials [1484 Associated Clinical Trials listed on BioPortfolio]

A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Advanced Pancreatic Cancer

The study is being conducted to: a) evaluate the tolerability and safety of the co-administration of Fluzoparib and mFOLFIRINOX followed by Fluzoparib Maintenance Monotherapy in patients w...

A Study of Fluzoparib Given in Combination With Apatinib in Ovarian or Breast Cancer Patients

Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibi...

A Trial of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With Apatinib and Fluzoparib in Patients With TNBC

The study is being conducted to evaluate the tolerability, safety and efficacy of SHR-1210 in combination with Apatinib and Fluzoparib in subjects with recurrent and metastatic triple nega...

A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients

To evaluate the efficacy, safety tolerability of maintenance therapy with Fluzoparib(A PARP inhibitor) versus placebo in Chinese patients with recurrent ovarian cancer who achieved a compl...

A Drug-drug Interaction Trial of Rifampicin Pharmacokinetics Effect on Fluzoparib

The primary objective of the study was to assess the effect of repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Fluzoparib. The secondary objective of ...

PubMed Articles [39619 Associated PubMed Articles listed on BioPortfolio]

Fluzoparib increases radiation sensitivity of non-small cell lung cancer (NSCLC) cells without BRCA1/2 mutation, a novel PARP1 inhibitor undergoing clinical trials.

Poly (ADP-ribose) polymerase 1 inhibitors were originally investigated as anti-cancer therapeutics with BRCA1/2 genes mutation. Here, we investigate the effectiveness of a novel PARP1 inhibitor fluzop...

A randomized phase 2 trial of apatinib vs observation as maintenance treatment following first-line induction chemotherapy in extensive- stage small cell lung cancer.

Background The 5-year survival rate for extensive-disease small-cell lung carcinoma (ED-SCLC) is only 1%. Recently, apatinib exerted promising effects on cancer patients after failure of first-line ch...

Careful dose modification of apatinib as third or further-line treatment in advanced gastric cancer patients with poor performance status.

The retrospective study was conducted to evaluate the efficacy and safety of careful dose modification of apatinib as third or further-line treatment in advanced gastric cancer (aGC) patients with poo...

S-1 plus apatinib as first-line palliative treatment for stage IVB gastroesophageal junction adenocarcinoma: A case report and review of the literature.

Apatinib has been proven to significantly prolong the survival of the patients with advanced chemotherapy-refractory gastric cancer. To date, studies on apatinib plus S-1 as first-line palliative ther...

Lenalidomide maintenance for diffuse large B-cell lymphoma patients responding to R-CHOP: quality of life, dosing, and safety results from the randomised controlled REMARC study.

Lenalidomide maintenance therapy prolonged progression-free survival (PFS) versus placebo in elderly patients with diffuse large B-cell lymphoma (DLBCL) responding to induction chemotherapy in the pha...

Medical and Biotech [MESH] Definitions

The purpose of this 1990 federal act is to assure that individuals receiving health care services will be given an opportunity to participate in and direct health care decisions affecting themselves. Under this act, hospitals, health care agencies, and health maintenance organizations are responsible for developing patient information for distribution. The information must include patients' rights, advance directives, living wills, ethics committees' consultation and education functions, limited medical treatment (support/comfort care only), mental health treatment, resuscitation, restraints, surrogate decision making and transfer of care. (from JCAHO, Lexicon, 1994)

A treatment method in which patients are under direct observation when they take their medication or receive their treatment. This method is designed to reduce the risk of treatment interruption and to ensure patient compliance.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Incision of Oddi's sphincter or Vater's ampulla performed by inserting a sphincterotome through an endoscope (DUODENOSCOPE) often following retrograde cholangiography (CHOLANGIOPANCREATOGRAPHY, ENDOSCOPIC RETROGRADE). Endoscopic treatment by sphincterotomy is the preferred method of treatment for patients with retained or recurrent bile duct stones post-cholecystectomy, and for poor-surgical-risk patients that have the gallbladder still present.

Work consisting of a clinical trial involving one or more test treatments, at least one control treatment, specified outcome measures for evaluating the studied intervention, and a bias-free method for assigning patients to the test treatment. The treatment may be drugs, devices, or procedures studied for diagnostic, therapeutic, or prophylactic effectiveness. Control measures include placebos, active medicine, no-treatment, dosage forms and regimens, historical comparisons, etc. When randomization using mathematical techniques, such as the use of a random numbers table, is employed to assign patients to test or control treatments, the trial is characterized as a RANDOMIZED CONTROLLED TRIAL.

More From BioPortfolio on "A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy"

Quick Search

Relevant Topics

Ovarian Cancer
Ovarian Cancer is cancer that starts in the female reproductive organs, the ovaries. It is the fifth most common cancer among women.  Women at risk of Ovarian Cancer are those who have had few children (or had children at an older age), carriers o...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...


Searches Linking to this Trial