Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Adenocarcinoma, Clear Cell

Adenomyoepithelioma

Carcinoma, Endometrioid

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Endometrial Neoplasms

Uterine Neoplasms

Ovarian Cancer

Ovarian Epithelial Cancer

Epithelial-myoepithelial Carcinoma

Subjects will be treated with NXP800 at 50 mg/day.

Subjects will be treated with NXP800 at 75 mg/day.

NXP800 is an anti-neoplastic, oral small molecule.

NXP800

Diane Marsolini

Shay Shemesh, MSc

Alexandrea Cronin

Kassie DiOrio

Melissa Barnes

Ashley Douglas, RN, BSN, OCN

Ruth Orr

Udai Banerji, Prof

Susana Banerjee, Dr

The purpose of the dose escalation phase is to evaluate the safety profile of escalating doses and dose schedules of NXP800. In the expansion phase the preliminary efficacy in subjects with ARID1a mutated ovarian clear cell and ovarian endometrioid cancers will be estimated.

Part A of the study is a dose escalation by cohort study of NXP800 administered to patients with advanced cancers. The study will identify the maximum tolerated dose (MTD) and propose dose and dose schedules for future studies.

In Part B doses selected in Part A are administered to patients with platinum-resistant, ARID1a-mutated ovarian carcinoma.

Part A dose escalation followed by Part B, expansion in ovarian cancers.

Part B is enrolling ovarian cancer patients.

A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer

European Network of Gynaecological Oncological Trial Groups (ENGOT)

GOG Foundation

Nuvectis Pharma, Inc.

Symptoms and General Pathology

Recurrence

Disease Attributes

Uterine Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bevacizumab

Niraparib

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily.

Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. Bevacizumab (15 mg/kg, IV on day 1 of each cycle).

SCC IIT Office

Lead Nurse

Lauren Dockery, MD

The purpose of this research study is to test the proportion of tumor response to the combination treatment with niraparib and bevacizumab and see what effects (good and bad) this combination treatment has on patients with recurrent endometrial or ovarian cancer with ARID1A mutation.

Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will be randomized into one of two groups and receive treatment as follows: If patients are in the first group,they will receive niraparib alone, once daily taken by mouth. If patients are in the second group, they will receive niraparib once daily taken by mouth and infusion of bevacizumab once every 3 weeks.

Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable, bad side effects.

Patients will be monitored during treatment with tests and exams and after treatment completion for up to 3 years.

Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation

Phase 2 Trial of Niraparib or Niraparib and Bevacizumab Combination in Patients With Recurrent Endometrial Cancer and/or Ovarian Cancer With ARID1A Mutation (OU-SCC-ARID1A)

To estimate the proportion of patients with objective tumor response (complete or partial), to the combination treatment of niraparib and bevacizumab and to monotherapy niraparib.

To characterize the safety and toxicity profile of each regimen in study subjects, measured by the incidence of Adverse events (AEs), serious AEs (SAEs), physical examinations, clinical laboratory values and tolerability (dose interruptions/reductions).

To estimate the proportion of subjects with recurrent endometrial cancer or ovarian cancer with mutated ARID1A, who survive progression-free for at least 6 months, treated with each regimen.

To estimate the progression-free survival (PFS) of subjects with recurrent endometrial cancer or ovarian cancer with mutated ARID1A treated with each regimen.

GlaxoSmithKline

University of Oklahoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1 Clinical Study of NXP800 in Subjects With Advanced Cancers and Expansion in Subjects With Ovarian Cancer	NCT05226507	Advanced Solid ... Ovarian Cancer Ovarian Clear C... Ovarian Clear C... Ovarian Clear C... Ovarian Endomet... Ovarian Endomet... ARID1A Gene Mut...	NXP800	18 Years -	Nuvectis Pharma, Inc.
Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation	NCT05523440	Recurrent Endom... Recurrent Ovari... ARID1A Gene Mut...	Bevacizumab Niraparib	18 Years -	University of Oklahoma
Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation	NCT05523440	Recurrent Endom... Recurrent Ovari... ARID1A Gene Mut...	Bevacizumab Niraparib	18 Years -	University of Oklahoma

Spots Global Cancer Trial Database for arid1a gene mutation