Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Recurrence

Carcinoma

Adenocarcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Cystadenocarcinoma, Serous

Brenner Tumor

Cystadenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Cystic, Mucinous, and Serous

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

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

Gonadal Disorders

Endocrine System Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Ovarian Low Malignant Potential Tumor

Adenocarcinoma of the Appendix

Brenner Tumor of Ovary

Patients receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis

Pharmacological Study

Selumetinib

Selumetinib Sulfate

John H Farley

This phase II trial studies the side effects and how well selumetinib sulfate works in treating patients with low-grade ovarian cancer that has come back (recurrent). Selumetinib sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To examine the tumor response rate of patients on AZD6244 (selumetinib sulfate) (NSC #748727).

II. To examine the acute toxicity of AZD6244 (NSC #748727) during the first course of treatment using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

III. To define the pharmacokinetic profile for AZD6244, 100 mg administered orally twice daily.

SECONDARY OBJECTIVES:

I. To examine the toxicity of AZD6244 (NSC #748727) using the 21 major categories of the CTCAE version 3.0.

II. To examine the dose and number of courses of AZD6244 (NSC #748727) given. III. To estimate the progression free survival, and overall survival of women receiving AZD6244 (NSC #748727).

TRANSLATIONAL RESEARCH OBJECTIVES:

I. To examine deoxyribonucleic acid (DNA) isolation with sequencing of braf, and ras mutation analysis and to explore their relationship with tumor response with AZD6244 (NSC #748727).

II. To examine protein levels of phosphorylated (p)-ERK/ERKERK) and explore their relationship with tumor response in patients treated with AZD6244 (NSC #748727).

OUTLINE:

Patients receive selumetinib sulfate orally (PO) twice a day (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection periodically for correlative and pharmacokinetic studies and to analyze selumetinib sulfate peak concentrations and the corresponding peak time values. Previously collected archived tumor tissue samples are obtained to determine protein levels of p-ERK/ERKERK, DNA isolation and sequencing of BRAF and ras mutation analysis by immunohistochemistry (IHC).

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then once a year for 5 years.

Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer

A Phase II Trial of AZD6244 (NSC# 748727) in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary or Peritoneum

Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0

NRG Oncology

National Cancer Institute (NCI)

Includes all adverse events reported (grade 1-5) regardless of attribution.

AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)

AZD6244

20-29 years

30-39 years

40-49 years

50-59 years

60-69 years

70-79 years

80-89 years

Age, Customized

Sex: Female, Male

Study began with 100mg BID mix \& drink (MD) formulation. AstraZeneca (AZ) switched to hydrogen-sulfate capsule (HC). AZ deemed 100mg BID MD equivalent to 50mg BID HC. As of 12/31/2010, patients got 50mg BID HC; four patients were on treatment then.

Angela M. Kuras, Associate Director of Data Management

Tumor Response

Progression-free Survival

Eligible and Treated Patients. Two patients still on study and have received 68 and 79 cycles of treatment.

Number of Courses Received

Leukopenia

Thrombocytopenia

Neutropenia

Anemia

Allergy/Immunology

Auditory/Ear

Cardiac

Coagulation

Constitutional

Dermatologic

Gastrointestinal

Genitourinary/Renal

Hemorrhage

Infection

Lymphatics

Metabolic

Musculoskeletal

Neurosensory

Other Neurological

Ocular/Visual

Pain

Pulmonary

Adverse Events (Grade 3 or Higher) During First Cycle of Treatment

Eligible and Treated Patients with all pharmacokinetic time points available

Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily.

Eligible and Treated Patients with at least one post-dose pharmacokinetic time point available

Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily.

Overall Survival

Overall Study

Endocrine Gland Neoplasms

To determine the optimal regimen, either avutometinib(VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, for subsequent evaluation for efficacy in the Expansion Phase (Part B)

To determine the efficacy of the optimal regimen identified from Part A

To evaluate additional efficacy parameters for the optimal regimen identified in Part A.

To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib

avutometinib (VS-6766)

avutometinib (VS-6766) and defactinib combination

avutometinib (VS-6766) and defactinib

Susana Banerjee, MBBS,MA,PhD

Rachel Grisham, MD

MD Verastem

This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy and in combination with defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

This is a multicenter, randomized, open-label Phase 2 study designed to evaluate safety and tolerability and preliminary efficacy of avutometinib (VS-6766) versus avutometinib (VS-6766) in combination with defactinib in subjects with molecularly profiled recurrent LGSOC.

A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation

A Phase 2 Study of Avutometinib (VS-6766) (Dual RAF/MEK Inhibitor) Alone and In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

Confirmed overall response rate per RECIST 1.1

Confirmed ORR defined according to RECIST 1.1

Proportioned subjects achieving a CR or PR as assess by the investigator

From time of first response to PD as assessed by the BIRC

From time of first dose of study intervention to PD or death for any cause

From time of first dose of study intervention to death

European Network of Gynaecological Oncological Trial Groups (ENGOT)

GOG Foundation

Verastem, Inc.

Patients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored.

Patients' residual tissue samples are collected

Biospecimen Collection

Electronic Health Record Review

Lisa Nathan

David M. Gershenson

David M Gershenson

This study collects information to maintain a database on patients with low-grade ovarian or peritoneal tumors. Collecting information about the type of cancer and treatment, as well as details about follow-up care, may help researchers learn and better understand these tumor types and help develop better treatments for them.

PRIMARY OBJECTIVES:

I. To collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for approximately 1600 female patients with low-grade ovarian and peritoneal tumors.

II. To organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.

III. To have a single data repository, kept on a secure platform that will integrate clinical information and research findings and serve as a secure archive for future research.

SECONDARY OBJECTIVE:

I. To obtain and store human tumor samples in the form of blocks or slides for the purpose of establishing a tumor bank.

OUTLINE:

Patients' medical records are reviewed for retrospective and prospective data collection. Patients may also have residual tissue samples collected and stored.

Data Collection for Patients With Low Grade Ovarian or Peritoneal Tumors

Data Collection for Patients With Low Grade Ovarian Carcinoma

Will be done in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer	NCT00551070	Borderline Ovar... Low Grade Ovari... Micropapillary ... Primary Periton... Primary Periton... Recurrent Borde...	Laboratory Biom... Pharmacological... Selumetinib Selumetinib Sul...	19 Years -	National Cancer Institute (NCI)
A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation	NCT04625270	Low Grade Ovari... Ovarian Cancer	avutometinib (V... avutometinib (V...	18 Years -	Verastem, Inc.
Data Collection for Patients With Low Grade Ovarian or Peritoneal Tumors	NCT00488878	Low Grade Ovari... Malignant Ovari... Ovarian Carcino... Primary Periton... Primary Periton... Psammocarcinoma	Biospecimen Col... Electronic Heal...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for low grade ovarian serous adenocarcinoma