Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Pancreatic Diseases

Digestive System Neoplasms

Adnexal Diseases

Ovarian Diseases

Carcinoma

Endocrine Gland Neoplasms

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

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Injection of 89Zr-MMOT0530A followed by 2 or 3 PET scans at different time points

89Zr-MMOT0530A

Elisabeth G. de Vries, MD PhD

Henk M Verheul, MD PhD

The purpose of this multicenter imaging sub study is to evaluate the biodistribution and organ pharmacokinetics of 89Zr-MMOT0530A in patients with unresectable pancreatic or platinum-resistant ovarian cancer. MMOT0530A is a monoclonal antibody that targets an antigen overexpressed in pancreatic and ovarian cancer. Subsequent to imaging with 89Zr-MMOT0530A, patients will be treated with DMOT4039A in the DMO4993g protocol (clinicaltrials.gov identifier NCT01469793) after this study. DMOT4039A is an antibody-drug conjugate composed of the monoclonal antibody MMOT0530A and the mitotic agent monomethyl auristatin (MMAE). By imaging patients with the monoclonal antibody MMOT0530A before treatment, the correlation between tumor uptake of 89Zr-MMOT0530A and response to DMOT4039A therapy will be assessed.

A challenge in current drug development using molecular targeted therapies is the high level of heterogeneity that is present in specific tumor types. The ability to safely and accurately predict the presence or absence of the target is essential for the therapeutic effect of the newly developed drugs. DMOT0439A is one of those novel designed molecular targeted drugs; an antibody-drug conjugate composed of the monoclonal antibody MMOT0530A and the mitotic agent monomethyl auristatin (MMAE). In the DMO4993g protocol (clinicaltrials.gov identifier NCT01469793), the safety and efficacy of DMOT4039A is assessed in patients with unresectable pancreatic or platinum-resistant ovarian cancer. By performing a 89Zr-MMOT0530A PET scan prior to treatment with DMOT4039A, the uptake of the tracer in the primary and metastatic tumor lesions can be evaluated. This is likely to provide important information about target expression, whole body drug distribution and the correlation between tumor uptake and response to therapy. Ultimately the use of a 89Zr- MMOT0530A PET as a complimentary tool for patient selection and risk stratification can be evaluated. In part A of this study, the optimal tracer dose of 89Zr- MMOT0530A and schedule for PET imaging will be determined. In part B patients will have PET imaging before treatment in the DMO4993g study on the dose and time points as assessed in part A.

89Zr-MMOT PET Imaging in Pancreatic and Ovarian Cancer Patients

89Zr-MMOT0530A PET Imaging in Patients With Unresectable Pancreatic or Platinum-resistant Ovarian Cancer Before Treatment With DMOT4039A. A Separate Study to the Phase I Study Protocol DMO4993g

* The accumulation, distribution and localization of 89Zr-MMOT0530A in tumor tissue, organs and blood circulation, as assessed by PET.
* The quantitative uptake of 89Zr-MMOT0530A expressed in SUV (Standardized Uptake value).

The correlation between the 89Zr-MMOT0530A tumor uptake and response to therapy by performing an 89Zr-MMOT0530A PET scan before DMOT4039A therapy, related to CT/MRI response according to RECIST 1.1 criteria.

Safety will be assessed by evaluation of incidence of adverse events.

Amsterdam UMC, location VUmc

Genentech, Inc.

University Medical Center Groningen

Symptoms and General Pathology

Behaviors and Mental Disorders

Neoplasm Metastasis

Urologic Diseases

Male Urogenital Diseases

Quality of Life

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Cisplatin

Ocoxin-Viusid® before, during and after the Chemotherapy treatment.

Ocoxin-Viusid group (Experimental): Oral solution Ocoxin-Viusid (30 ml vials) were used at a rate of 60ml / day (1 vial every 12 hours), preferably administered after breakfast and dinner. The treatment will start a week before start Chemotheray treatment (CT) and, It will maintenance until 3 weeks after finished the last cycle of CT (3 cycles of CT of Carboplatin/Paclitaxel or Cisplatin/ Paclitaxel with neoadjuvant intent).

Ocoxin-Viusid

Our hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy.

General Objectives -To identify the efficacy of the nutritional supplement Ocoxin-viusid to increase the quality of life of patients with epithelial advanced or metastatic ovarian cancer. Specific Objectives - Identify the influence of the research product on the nutritional status and quality of life of patients. - Describe the toxicity of the research product. - Identify the adverse reactions to the chemotherapy scheme and quantify the interruptions to it by acute toxicity.

Quality of life. It will be measured as: - EORTC Questionnaire QLQ-C30 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - EORTC Questionnaire QLQ-OV28 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - Karnofsky index (Score of 0-100 points at intervals of 10). Measurement time: at the beginning, in each cycle of QT and 3 weeks after the 3rd cycle of QT

Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer

Efficacy of the Oncoxin-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced or Metastatic Ovarian Epithelial Cancer. Clinical Trial Phase II.

It will measured by: - EORTC QLQ-C30 (Points of every item and final points)

Karnofsky index (Score of 0-100 points at intervals of 10)

EORTC QLQ-OV28 (Points of every item and final points)

Catalysis SL

Cysts

Ovarian Cysts

Standardized transvaginal ultrasound examination

Dirk Timmerman, MD, PhD

Wouter Froyman, MD

Dirk Timmerman, PhD

Tom Bourne, MD, PhD

Ben Van Calster, MSc, PhD

Ignace Vergote, MD, PhD

Lil Valentin, MD, PhD

Antonia C Testa, MD, PhD

Sabine Van Huffel, MSc, PhD

The ability of different methods to discriminate between benign and malignant adnexal masses has been compared in a meta-analysis showing that the IOTA Simple Rules and the IOTA logistic regression model LR2 were superior to RMI and to all other methods for predicting malignancy in an adnexal mass included in the meta-analysis. However, a fair comparison of methods requires them to be applied on the same tumor population.

The general objective of this study is to prospectively validate the Simple Rules, ADNEX, the Simple Rules risk model, LR2, and RMI on a large multicenter dataset to allow direct comparison of these tools.

IOTA7 is an international multicenter prospective observational study including different types of ultrasound centers and examiners with different levels of ultrasound experience. In total, about 1700 adnexal masses with histological outcome will be included in IOTA 7.

Ovarian cancer is a common and lethal disease for which early detection and treatment in high volume centers and by specialized clinicians is known to improve survival. Hence, accurate methods to preoperatively characterize the nature of an ovarian tumor are pivotal.

The best ultrasound method for discrimination between benign and malignant adnexal masses is subjective assessment, i.e. subjective evaluation of ultrasound findings. Subjective assessment, however, requires a very experienced ultrasound examiner. More objective methods may be preferred by less experienced examiners who are not confident with using subjective assessment. The Risk of Malignancy Index (RMI) is one such method. There are also more recently developed methods. The International Ovarian Tumor Analysis (IOTA) group have created logistic regression models (LR1, LR2, and the ADNEX model) including clinical and ultrasound information to calculate the likelihood of malignancy in adnexal masses.

The IOTA group has also suggested simple ultrasound rules that can be used to classify adnexal masses as benign or malignant.

The ability of different methods to discriminate between benign and malignant adnexal masses has been compared in a meta-analysis showing that the IOTA Simple Rules and the IOTA logistic regression model LR2 were superior to RMI and to all other methods for predicting malignancy in an adnexal mass included in the meta-analysis. However, a fair comparison of methods requires them to be applied on the same tumor population.

The general objective of this study is to prospectively validate the Simple Rules, ADNEX, the Simple Rules risk model, LR2, and RMI on a large multicenter dataset to allow direct comparison of these tools. The patients will be examined by operators of varying levels of experience, such that the investigators can study how experience might affect diagnostic performance.

IOTA7 is an international multicenter prospective observational study including different types of ultrasound centers and examiners with different levels of ultrasound experience. In total, about 1700 adnexal masses with histological outcome will be included in IOTA 7.

Patients with a known or suspected adnexal mass examined with transvaginal (or transrectal if vaginal is not possible) ultrasound by an IOTA certified ultrasound examiner and confirmed to have an adnexal mass judged not to be physiological but likely to undergo surgery (primarily planned for surgical management based on subjective assessment by the ultrasound investigator) will be recruited consecutively Upon inclusion in the study, an oral or written (depending on the requirements of the local Ethics Committee) informed consent is obtained from the patient.

Data collection is done through the web-based clinical data miner (CDM) software. Data are stored on a secure server.

First, clinical information about the patient is entered into CDM. Second, the ultrasound examiner provides a diagnosis based on subjective assessment, and notes the suggested management. Third, detailed ultrasound information needed for the different models to be validated is entered. When these data have been frozen (so they can no longer be changed) the examiner gets access to the results of the Simple Rules and ADNEX. The ultrasound examiner then records whether these results make him/her change the management suggested on the basis of subjective assessment. If so the new management is specified.

Gold standard for validation of discriminative ability and calibration is the histology of the adnexal mass within 180 days after the ultrasound examination following surgical removal by laparotomy or laparoscopy as considered appropriate by the surgeon. In case of malignancy, the stage of the malignant tumors using the classification of the International Federation of Gynecology and Obstetrics (FIGO) is noted.

Prospective Validation and Comparison of Different Ultrasound Methods for Discrimination Between Benign and Malignant Ovarian/Tubal Masses Prior to Surgery

Prospective Validation and Comparison of Subjective Assessment, the International Ovarian Tumor Analysis (IOTA) ADNEX Model, Logistic Regression Model LR2, Simple Rules and the Risk of Malignancy Index (RMI) for Discrimination Between Benign and Malignant Adnexal Masses in the Hands of Ultrasound Examiners With Different Levels of Experience

KU Leuven

Prof. Dr.

Blood and Lymph Conditions

Immune System Diseases

Prostatic Neoplasms

Leukemia

Leukemia, Lymphoid

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Prolymphocytic

Leukemia, Prolymphocytic, T-Cell

Prostatic Diseases

Genital Diseases, Male

Genital Neoplasms, Male

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Leukemia, T-Cell

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

T-cell Prolymphocytic Leukemia

Niraparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

MK-4827 in 10 mg and 100 mg capsules given daily in a 21 day dosing cycle (dose escalation to RP2D).

MK-4827

This is a four-part dose-escalation and confirmation study in participants with advanced solid tumors. Part A is for dose escalation and determination of maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of MK-4827. Part B is a prostate/ovarian cancer cohort expansion. Part C is for a cohort of participants with relapsed or refractory T-cell prolymphocytic leukemia (T-PLL) or chronic lymphocytic leukemia (CLL). Part D will be for a cohort of participants with locally advanced or metastatic colorectal carcinoma (CRC), persistent or recurrent endometrial carcinoma, locally advanced or metastatic triple negative or highly proliferative estrogen receptor positive (ER+) breast cancer, or partially platinum-sensitive epithelial ovarian cancer. The study is also designed to find out whether MK-4827 causes at least 50% inhibition of poly adenosine diphosphate ribose polymerase (PARP) enzyme activity.

A Study of MK4827 in Participants With Advanced Solid Tumors or Hematologic Malignancies (MK-4827-001 AM8)

A Phase I Study of MK-4827 in Patients With Advanced Solid Tumors or Hematologic Malignancies

Tesaro, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
89Zr-MMOT PET Imaging in Pancreatic and Ovarian Cancer Patients	NCT01832116	Ovarian Neoplas... Ovarian Disease... Adnexal Disease... Pancreatic Neop... Digestive Syste... Digestive Syste... Pancreatic Dise...	89Zr-MMOT0530A	18 Years -	University Medical Center Groningen
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer	NCT03562897	Carcinoma Ovarian Neoplas... Endocrine Gland... Urogenital Neop... Ovarian Disease... Adnexal Disease... Genital Disease... Female Urogenit... Female Urogenit... Endocrine Syste... Gonadal Disorde... Genital Neoplas... Neoplasms, Glan...	Ocoxin-Viusid	18 Years -	Catalysis SL
Prospective Validation and Comparison of Different Ultrasound Methods for Discrimination Between Benign and Malignant Ovarian/Tubal Masses Prior to Surgery	NCT02847832	Patients With A...	Standardized tr...	-	KU Leuven
A Study of MK4827 in Participants With Advanced Solid Tumors or Hematologic Malignancies (MK-4827-001 AM8)	NCT00749502	Solid Tumors Chronic Lymphoc... T-cell-prolymph...	MK-4827	18 Years -	Tesaro, Inc.
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer	NCT03562897	Carcinoma Ovarian Neoplas... Endocrine Gland... Urogenital Neop... Ovarian Disease... Adnexal Disease... Genital Disease... Female Urogenit... Female Urogenit... Endocrine Syste... Gonadal Disorde... Genital Neoplas... Neoplasms, Glan...	Ocoxin-Viusid	18 Years -	Catalysis SL

Spots Global Cancer Trial Database for adnexal diseases