Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

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

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Paclitaxel

Doxorubicin

Liposomal doxorubicin

Letrozole

Albumin-Bound Paclitaxel

Topotecan

Anastrozole

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Aromatase Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Topoisomerase I Inhibitors

Antineoplastic Agents, Hormonal

Avutometinib 3.2 mg, PO, twice weekly (eg, Monday/Thursday, Tuesday/Friday, or Wednesday/Saturday) for 21 days on, 7 days off in a 28-day (4 weeks) cycle in combination with defactinib 200 mg, PO, twice daily for 21 days on, 7 days off in a 28-day(4 week) cycle.

Patients will receive one of the following therapies as determined by the Investigator:

* Pegylated liposomal doxorubicin: 40 mg/m2 IV on Day 1 of each 28-day (4 week) cycle.
* Paclitaxel: 80 mg/m2 IV on Days 1, 8, and 15 of each 28-day (4 week) cycle.
* Topotecan: 4 mg/m2 IV on Days 1, 8, and 15 of each 28-day (4 week) cycle.
* Anastrozole: 1 mg, PO, once daily of each 28-day (4 week) cycle.
* Letrozole: 2.5 mg, PO, once daily of each 28-day (4 week) cycle.

avutometinib

Defactinib

Pegylated liposomal doxorubicin

Verastem Call Center

Kelly Fillbrant

Lyndsay Willmott, MD

Surya Nagesh

Ritu Salani, MD

Lisa Baker

Alessandro Santin, MD

Karla Hernandez-Cruz

Robert Holloway, MD

Mary Jo Luser

Bradley Monk, MD

Michele Britto

Mary Tilley Jenkins-Vogel, MD

Elizabeth Linnik

Robert Morris, MD

Kayla McDonald

Lauren Bollinger, MD

Linda Odibo

Premal Thaker, MD

Rachel Grisham

Rachel Grisham, MD

Jacqueline Ludwig

Peter Rose, MD

Stephanie Chaney

Christina Washington, MD

Jeanne Scahffer

Charles Anderson, MD

Jennifer Thompson

Erin Salinas, MD

Siobhan Guyach

Thomas Krivak, MD

Michelle Owens

Lynn Knowles, MD

Nori Sullivan

Noelle Cloven, MD

Shannon Syring

Antonio Santillan Gomez, MD

Christina Genthon

Sandra Thornton

Christine Lee, MD

Shelly Maxfield

Anna M Priebe, MD

Magnifique Irakoze

Kari Ring, MD

Monica Cochrane

Robert Marsh, MD

Amy Morrow

Jeffrey Goh, MD

Vineet Kwatra, MD

Meena Okera, MD

Christian Paul Medina

Shibani Nicum, MD

Rowan Miller, MD

Kylie Fitch

Susana Banerjee, MD

Susana Banerjee, MBBS, MA, PhD

MD Verastem

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.

This international, randomized, open-label, Phase 3 study will compare the investigational combination of avutometinib plus defactinib versus Investigator's Choice of Treatments (ICT) in patients with recurrent LGSOC who have progressed on a prior platinum-based therapy. Avutometinib and defactinib are both a type of drug called a kinase inhibitor. Kinase inhibitors block cancer cell growth. The study will compare the progression-free survival (PFS) of the combination of avutometinib plus defactinib versus ICT. The study will also evaluate the effect of the combination on safety, overall survival, other efficacy endpoints, and health-related quality of life and disease related symptoms. The study is being conducted by gynecological cancer specialists. Patients who are eligible and agree to participate in this study will be treated with either a combination of avutometinib with defactinib, or with one of five standard of care NCCN and ESMO treatment recommendations for recurrent LGSOC, and then with subsequent follow up appointments. Patients who originally received one of the standard of care treatments who are determined to have progressive disease may be eligible to crossover to receive the investigational combination avutometinib plus defactinib.Avutometinib and defactinib are investigational drugs that have not been approved by the U.S. Food and Drug Administration (FDA)

A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer

A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)

Confirmed overall response rate per RECIST 1.1 per blinded independent central review (BICR)

From the time of first dose of study intervention to PD as assessed per RECIST 1.1 or death from any cause

From the time of first dose of study intervention to PD as assessed per RECIST 1.1 by Investigator or death from any cause

Count of AE and SAEs by grade, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale

Area under plasma Concentration (AUC) 0 to t

The EORTC QLQ-C30 is a questionnaire to assess quality of life of ovarian cancer patients. It is composed of 30 questions. An overall scoring range is from 0 to 100. A high scales score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of function, a high score for the global health status/QOL represents a high QOL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. Quality of life measured by EORTC QLQ-C30. These are validated questionnaires to be answered by patients.

The EORTC QLQ-OV28 is a questionnaire to assess quality of life of ovarian cancer patients. It is composed of 28 questions. An overall scoring range is from 0 to 100. A high scales score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of function, a high score for the global health status/QOL represents a high QOL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.

GOG Foundation

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Verastem, Inc.

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Amino Acids

Bevacizumab

Capecitabine

Erlotinib Hydrochloride

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

bevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily

bevacizumab, erlotinib

bevacizumab 7.5 mg/kg body weight every third week

bevacizumab

bevacizumab 7.5 mg/kg body weight every third week.

low dose capecitabine

Patients with metastatic colorectal cancer will be treated with chemotherapy according to investigators choice. In addition to chemotherapy treatment, treatment with bevacizumab will be given concomitantly. This treatment will continue during 18 weeks. Meanwhile, the patients KRAS status will be tested. After having fulfilled these 18 weeks of induction treatment, patients who has responded (complete response/partial response versus stable disease) will be randomized to maintenance treatment. Patients with KRAS WT will be randomized to either bevacizumab alone, or to bevacizumab and erlotinib. Patient with KRAS mutation will be randomized to either bevacizumab, or metronomic capecitabine. Translational research is performed, with purpose to find predictive factors in blood and tumor tissue.

Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.

Hoffmann-La Roche

Lund University Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer	NCT06072781	Low Grade Serou...	avutometinib Defactinib Pegylated lipos... Paclitaxel Topotecan Letrozole Anastrozole	18 Years -	Verastem, Inc.
Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.	NCT01229813	Colorectal Canc...	bevacizumab, er... bevacizumab bevacizumab low dose capeci...	18 Years -	Lund University Hospital
Avastin and Chemotherapy Followed by a KRAS Stratified Randomization to Maintenance Treatment for First Line Treatment of Metastatic Colorectal Cancer.	NCT01229813	Colorectal Canc...	bevacizumab, er... bevacizumab bevacizumab low dose capeci...	18 Years -	Lund University Hospital

Spots Global Cancer Trial Database for kras wt

Every month we try and update this database with for kras wt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for kras wt

Every month we try and update this database with for kras wt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for kras wt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.