Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Carcinoma

Disease Attributes

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

Olaparib

Women with platinum-sensitive recurrent serous ovarian cancer

Colleciton of data from medical records only

Data Collection

Nicoletta Colombo, MD

Laurence Gladieff, MD

Sven Mahner, MD

Isabel Bover, MD

Jacob Korach, MD

This study will be carried out as a retrospective, non-interventional observational review of medical records for patients in multiple countries with platinum-sensitive recurrent serous ovarian cancer. The objectives are to describe in a real-world population, treatment patterns, BRCA mutation testing and results, overall survival, health care utilization and also to estimate rates of selected treatment- and/or disease-related side effects

OSCA - Olaparib Standard of CAre Study

Real-World Treatment Patterns, BRCA Testing Practices, Outcomes, and Health Care Utilization in Platinum-Sensitive Recurrent Serous Ovarian Cancer: A Multi-Country Retrospective Study

Response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) Criteria on which physicians determined therapy response also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria).

Defined as time from initiation of the therapy line (including the required first-line platinum-based chemotherapy) until the earliest of progression, death, or end of follow-up (for censored observations) Criteria on which physicians determined progression also will be captured (e.g., symptoms, radiological and/or other imaging findings, CA-125 levels, physical exam, or other criteria)

From first diagnosis of ovarian cancer until death or end of follow-up, whichever is earliest From initiation of the required first-line platinum-based chemotherapy regimen until death or end of follow-up, whichever is earliest From the index date (first determination of platinum-sensitive recurrence) until death or end of follow-up, whichever is earliest From initiation of each subsequent, post-index therapy line until death or end of follow-up, whichever is earliest

RTI Health Solutions

A+A Healthcare Marketing Research

Freelance CRA (FCRA)

AstraZeneca

Cystadenocarcinoma, Serous

Cystadenocarcinoma

Adenocarcinoma

Neoplasms, Cystic, Mucinous, and Serous

Adenocarcinoma of the Appendix

ZN-c3 (azenosertib) taken orally with food

ZN-c3

Project Director

Andrea Castelblanco

Melissa Hardesty

Lyndsay Willmott

Kelly Fillbrandt

Lyndsey Willmott, MD

Stacey Kimbell

Julie Klinker

Joseph Buscema, MD, PhD

Krishnansu Tewari, MD

Lee-may Chen, MD

Ana Lacombe, BA, MBA

Yvonne Enriquez

Brian Slomovitz, MD

Angele Price, BSN, RN

Kristen McKenzie, BSN, RN

Beverly Long, MD

Matthew Anderson, MD

Meaghan Tenney, MD

Northside Hospital - Central Research Department

Emily Sarria, BSN, RN

Sara Mobley, BSN, RN

Sharad Ghamande, MD

Teresa Saavedra

Jeanine Werner, MD

Shelby Fragetta

Kristyn Poopert

Dana Roque, MD

Esther Peariso

Gregory Gressel, MD

Megan Werner

Lauren Babcock

Kristopher Lybarger, MD

Shannon Pierpoint, OCN CRC

Reyna Vanderkelen

Peter Lim, MD

Kelly Gruber

Khadijah Abass

Eugenia Girda, MD

Milena Overby

Karen Finkelstein, MD

Allyson Pulsoni

Tana Pradhan, DO

Jessica Mullins

Margan Harris

Caroline Billingsley, MD

Ajit Gubbi, MD

Robert Neff, MD

Sainath Koth

Floortje Backes, MD

Christine Pappaterra

Debra Richardson, MD

Charles Anderson, MD

Christopher Darus, MD

Jennifer Thompson, RN

Elaine Bigler, RN

Erin Salinas, MD

Sarmina Hassan, MBBS., PhD

Christine Benckert, RN

Enrique Hernandez, MD

Michael Stany, MD

Michelle Owens, RN, OCN

Lynne Knowles, MD

Noelle Cloven, MD

Christina Genthon, BSN

Sandra Thornton, RN, MSN

Christine M. Lee, MD

Debbie Ponce

Shannon Syring, RN ONC CCRC

Joseph De La Garza, MD

Hannah Snow, RN, BSN

Jungeun Kim, PhD

Linda Duska, MD

Melanie Hamilton

Leslie Randall, MD

Carrie Friedman, RN, BSN, OCN

Robert Marsh, MD

Subarna Paul

William Bradley, MD

Jesse Peet

Jeffrey Goh, MD

Catherine Shannon, MD

Leyna Tran

Gary Richardson, MD

Xiaoyi Mackenzie

George Au-Yeung, MD

Jolanta Damas

Tarek Meniawy, MD

This is a Phase 2 study to evaluate the clinical activity and safety of ZN-c3 (azenosertib) in adult women with recurrent or persistent uterine serous carcinoma (USC).

This is a Phase 2 open-label, multicenter study to evaluate the clinical activity and safety of ZN-c3 (also known as azenosertib; KP-2638) in adult women with recurrent or persistent uterine serous carcinoma (USC).

A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma

A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Adult Women With Recurrent or Persistent Uterine Serous Carcinoma

To determine the safety and tolerability of ZN-c3 in subjects with recurrent or persistent USC.

To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC

To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Skin and Connective Tissue Diseases

Digestive System Diseases

Breast Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Breast Diseases

Skin Diseases

Hematinics

Liver Extracts

Triple negative breast cancer patients with residual invasive disease following neoadjuvant chemotherapy (n= up to 15) or with newly diagnosed metastatic disease (n=up to 30).

After the screening procedures confirms patient eligibility:

* Molecular Profiling will be performed on clinical sample
* pPDX generation for in vivo drug testing
* In vitro organoid culture generation (if sufficient fresh tissue available)
* Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.

Colorectal cancer patients with metastatic disease undergoing resection of liver metastases, or with lesions amenable to biopsy (n=up to 15).

After the screening procedures confirms patient eligibility:

* Molecular Profiling will be performed on clinical sample
* pPDX generation for in vivo drug testing
* In vitro organoid culture generation (if sufficient fresh tissue available)
* Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.

High grade serous ovarian cancer patients with recurrent disease with a life expectancy of at least 12 months (n=up to 15), or Stage III or IV with residual disease following neoadjuvant chemotherapy, or at risk of high recurrence (n=up to 15).

After the screening procedures confirms patient eligibility:

* Molecular Profiling will be performed on clinical sample
* pPDX generation for in vivo drug testing
* In vitro organoid culture generation (if sufficient fresh tissue available)
* Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.

Other selected tumor types at the discretion of the PI (n= up to 30)

After the screening procedures confirms patient eligibility:

* Molecular Profiling will be performed on clinical sample
* pPDX generation for in vivo drug testing
* In vitro organoid culture generation (if sufficient fresh tissue available)
* Identifying an actionable genomic alteration and drug making a matched treatment therapy recommendation.

Molecular profiling of host tumour sample and pPDX will be performed and analyzed by an expert panel. In vitro organoid culture generation may also be performed if sufficient fresh tissue is available. Matched treatment recommendation based on profiling and in vivo pPDX drug testing results will be made, if available. This recommendation will be communicated to the primary oncologist.

Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures

David Cescon, MD

Elizabeth Shah

By obtaining clinical specimens from participants with triple negative breast cancer (TNBC), colorectal cancer (CRC), high grade serous ovarian cancer (HGSOC), and other select tumor types to establish and profile as freshly implanted tumors in mice, the aim of this study is to identify agents with predicted activity in the host patient while also potentially providing them with personalized cancer treatment options

Personalized patient-derived xenografts (pPDX) are increasingly used as tools for drug development in pre-clinical settings, and have been shown to recapitulate the histology and behavior of the cancers from which they are derived. Although, they have been commonly used productively as pre-clinical disease models to study disease biology and drug response, they have not been used prospectively to inform clinical management. pPDX have been employed to inform clinical decision-making in small studies, which have shown high concordance between individual pPDX and patient responses to therapy. While encouraging, the role of this approach in breast, colorectal, ovarian, and other cancer populations and in the context of genomic drug matching strategies remains undefined. This has created an opportunity to evaluate the utility of pPDX as clinical predictors to direct the use of chemo- and targeted therapies in combination with comprehensive genomic and epigenetic analysis for patients with TNBC, CRC, HGSOC and other selected tumor types.

Whole Blood, formalin fixed paraffin embedded blocks, fresh tumor tissue, malignant effusion or ascites (if no tumor tissue available), archival tissue (if not enrolled in molecular profiling studies IMPACT/OCTANE)

Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host

Prospective Evaluation of Freshly Implanted Cancers in Mice to Test Drug Response in Matching Host

Sensitivity measured by tumor growth inhibition (\>80%) or objective tumor response (regression) as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

Genomic alterations identified using the Ion Proton System for Next-Generation Sequencing (NGS).

Overall accuracy of clinical responses as assessed by RECIST criteria in patient tumor.

University Health Network, Toronto

Triple Negative Breast Neoplasms

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Olaparib twice daily (starting dose 50 mg) and BKM120 once daily (starting dose 40 mg). Both drugs are given orally.

BKM120 and Olaparib

Olaparib twice daily (starting dose 100 mg) and BYL719 once daily (starting dose 250 mg). Both drugs are given orally.

BYL719 and Olaparib

Ursula A. Matulonis, M.D.

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational combination of drugs. Phase I studies also try to define the appropriate dose of the investigational combination to use for further studies. "Investigational" means that the combination of these drugs is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved either of these drugs nor the combination of being tested for use in patients, including people with your type of cancer.

BKM120, BYL719 and olaparib are drugs that may stop cancer cells from growing abnormally. These drugs when combined in laboratory experiments with animals, have demonstrated anti-cancer activity. Information from these other research studies suggests that the following agents BKM120, BYL719 and olaparib, may help to shrink tumor cells in the types of cancers being studied in this research study.

In this research study, the investigators are looking for the highest dose that can be given safely and also to see if the combination of BKM120 or BYL719 and olaparib is effective in treating your type of cancer.

During this study, additional tests will be performed on a sample of your original tumor that has been stored in your institutions tissue banks. These tests will be performed on tumor tissue samples from previous biopsies or surgeries for your cancer. The research done on these samples will involve looking at DNA and proteins in your cancer to see if researchers can learn more about your type of cancer and understand how this combination of drugs might work on your tumor. Testing of this sample will not require you to undergo any additional research procedures.

Approximately 2 tablespoons of blood will be collected for research testing. This testing will involve looking at DNA and proteins in your blood to compare them with those seen in your cancer. This will be drawn before you begin taking the study drug.

You may also participate in an optional blood test for the BRCA gene. The BRCA gene test is a blood test that uses DNA analysis to see changes in either one of two breast cancer genes, known as BRCA1 or BRCA2. After having a BRCA gene test performed, you learn whether you carry an inherited BRCA gene mutation. If your blood is tested for the BRCA gene, the results will be reported to your study doctor who will share the results with you and provide information related to your personal risk of breast cancer. Having a BRCA gene mutation is rare, occurring in only about 1 in 1000 people. Inherited BRCA gene mutations are responsible for less than 5 to 10 percent of breast cancers and about 10 to 15 percent of ovarian cancers.

Participants in the dose expansion portion of the study may be asked to have a tumor biopsy done. The dose expansion phase for the combination of BKM120 and Olaparib has been determined. The combination of BYL719 and Olaparib is currently in the dose escalation phase and the dose expansion phase has not been determined. Before and after you begin taking BKM120 (or BYL719) and olaparib, your doctor may also ask you to participate in an optional study where you would have tumor biopsies done.

Participation in the tumor biopsy and blood test for the BRCA gene are optional, and whether you consent or refuse to undergo these additional tests will not affect your participation in the main research study.

Since the investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have high grade serious ovarian cancer or triple negative breast cancer, not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses.

All drugs are in oral form. If you take part in this research study, you will be given a study dosing calendar for each drug for each treatment cycle. Each treatment cycle lasts 4 weeks. BKM120 or BYL719 should be taken once daily in the morning, one hour after a light meal. Olaparib should be taken twice a day continuously, about twelve hours apart. The olaparib morning dose should be taken at the same time as BKM120 or BYL719 one hour after a light meal. The evening dose can also be taken one hour after a light meal or on an empty stomach either 1 hour before or 2 hours after meals. If you vomit either or both medications, record this on your diary and do not take another dose that day.

The investigators will assess your tumor by CT or MRI scan every 8 weeks. During Cycle 1, you will come into the clinic every week, and during cycle 2, you will come into clinic every 2 weeks. For all cycles thereafter, you will come in once every 4 weeks.

During study visits you will undergo some or all of the following: evaluation of performance status, recording of any healthy problems, physical exam including vital signs, list of medications taken since last visit, questionnaire to evaluate anxiety and depression, routine blood tests, research blood tests, Electrocardiogram and optional biopsy.

You will remain in this research study as long as you are benefitting from study treatment. If you are removed from the research study for any reason you may be followed for up to one year.

Phase I Study of the Oral PI3kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer

To determine the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of BKM120 and olaparib, and the combination of BYL719 and olaparib in patients with recurrent TNBC and HGSC.

To determine the safety and observed toxicities of the combination of BKM120 and olaparib, and the combination of BYL719 and olaparib in this population

To measure the drug levels of both BKM120 and olaparib, and both BYL719 and olaparib at different time points after they are started to see if either drug affects the metabolism and levels of the other. PK samples will be drawn in duplicate (one set to be sent to Astrazeneca and the second set to Novartis). BKM120 (or BYL719) and olaparib levels will be performed at the following timepoints:

1. prior to taking both BKM120 (or BYL719) and olaparib cycle 1, day 1.
2. Cycle 1, day 8: prior to dosing, 1, 2, 4, and 8 hours post am dosing.
3. Cycle 1, day 15: prior to dosing, 1, 2, 4, and 8 hours post am dosing.

To determine a preliminary anti-cancer activities of these combinations at the MTD and RP2D dose. Anti-cancer activities of these combinations will be measured by response rate by RECIST 1.1 in patients who have measurable cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
OSCA - Olaparib Standard of CAre Study	NCT02262273	Platinum-sensit...	Data Collection	18 Years -	AstraZeneca
A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma	NCT04814108	Uterine Serous ...	ZN-c3	18 Years -	K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Personalized Patient Derived Xenograft (pPDX) Modeling to Test Drug Response in Matching Host	NCT02732860	Colorectal Neop... Colorectal Canc... Breast Cancer Breast Neoplasm... Ovarian Cancer Ovarian Neoplas...	Molecular Profi...	18 Years -	University Health Network, Toronto
Phase I Study of the Oral PI3kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer	NCT01623349	Ovarian Cancer Breast Cancer	BKM120 and Olap... BYL719 and Olap...	18 Years -	Dana-Farber Cancer Institute
A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma	NCT04814108	Uterine Serous ...	ZN-c3	18 Years -	K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)	NCT05329545	High Grade Sero... Fallopian Tube ... Primary Periton...	Upifitimab rils... Placebo	18 Years -	Mersana Therapeutics
Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer	NCT00928642	Ovarian Cancer Primary Periton...	imatinib mesyla... Gemcitabine Int...	18 Years -	Henry M. Jackson Foundation for the Advancement of Military Medicine
Sub-type Specific Genomic Mutations in sBOTs	NCT03883542	Ovarian Neoplas...	genomic mutatio...	18 Years -	Universitair Ziekenhuis Brussel
Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer	NCT00928642	Ovarian Cancer Primary Periton...	imatinib mesyla... Gemcitabine Int...	18 Years -	Henry M. Jackson Foundation for the Advancement of Military Medicine
Sub-type Specific Genomic Mutations in sBOTs	NCT03883542	Ovarian Neoplas...	genomic mutatio...	18 Years -	Universitair Ziekenhuis Brussel
Phase I Study of the Oral PI3kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer	NCT01623349	Ovarian Cancer Breast Cancer	BKM120 and Olap... BYL719 and Olap...	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for serous

Every month we try and update this database with for serous 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 serous

Every month we try and update this database with for serous 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 serous 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.