oral daily dose for 21 days in a 28-day cycle

MPC-3100 (an Hsp90 inhibitor)

Andrew Beelen, MD

The purpose of this study is to see how safe the study drug is and to determine the best dose to use in cancer patients in the future.

The study drug is designed to reduce the activity of a protein known as "heat shock protein 90", or "Hsp90". Hsp90 is found in every cell in the human body and normally helps those cells (and the body) cope with stressful situations. In certain cancers, however, Hsp90 helps the cancer cells survive and grow. By reducing the activity of Hsp90, the study drug may slow the growth, and reduce the survival, of those cancer cells.

This is a dose escalation study. As subjects participating in the study tolerate a specific dose level, the new subjects entering will be given a higher dose of the study drug.

Safety Study of MPC-3100 in Cancer Patients Who Have Failed Other Treatments

Phase 1 Study of MCP-3100 in Patients With Refractory or Relapsed Cancer

Myrexis Inc.

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Study of observant or nonobservant patient behavior for their oral drug treatment

Completion of questionnaires at 4 times during patient's oral route drug treatment

observance of oral drug treatment

Francoise GRUDE, Pharmacist

Fanny MARHUENDA, phD

Abadie-Lacourtoisie Sophie, MD

Bigot Pierre, MD

Hasbini Ali, MD

Schlürmann Friedricke, MD

L'Haridon Tifenn, MD

Cojocarasu Oana, MD

Voog Eric, MD

El Kouri Claude, MD

Laguerre Brigitte, MD

Artignan Xavier, MD

Desclos herve, MD

Deguiral Philippe, MD

Monpetit Erik, MD

Generally, in the trials, an observant patient is described as correctly taking 90 to 100% of the prescribed doses. Here, the 80% compliance rate will be the cut-off between observant and non-observant patients.

The evaluation methodology is based primarily on a survey of patients with metastatic or locally advanced kidney cancer who have just began an oral treatment protocol. The constitution of this cohort will be made from newly treated patients included by oncologists. The survey consists of implementing a series of questionnaires with each patient of the sample throughout the course of oral cancer care.

This series of questionnaires will aim to identify:

* the gradient of compliance of the patient with his treatment,
* all the factors likely to influence positively or negatively the latter, whether medical, material or socio-economic,
* the evolution of patient compliance during their treatment course,
* a patient's quality of life index through the standardized quality of life survey form (EORTC - Quality of Life Questionnaire QLQ C30 version 3).
* These questionnaires will be supplemented by the medical record data (including information on tolerance and possible drug interactions). The representativeness of the patients surveyed will be established by comparing the statistical characteristics of the surveyed population with those of the aggregate anonymous global data obtained by the two Medical Department of the French Regional Health Insurance of the two regions. From the data compiled by this study, different econometric models of patient behavior will seek to establish, in particular, a relationship between the probability that a given patient will be either non or poorly observant and the various variables proved to be statistically significant.

Data obtained from patients via the questionnaires will be copied into a computer database and as follows :

* The date of birth (day, month and year),
* Sex,
* The patient's opinion and attitude towards the current treatment: compliance, adverse effects, lifestyle restrictions, changes in professional activity, family activities, relationships, physical fitness, moral, concomitant treatments, expenses not refunded parallels related to the management of adverse effects,
* The family situation, the number of children,
* Degrees obtained and employment,
* Net monthly income.

In parallel with the questionnaires, the Clinical Research Associate (CRAs) of the Observatory will collect data from the medical file on site. The data collected on an electronic Case Report Form (e-CRF) are as follows:

* Type of cancer, date of diagnosis and metastatic disease, possible surgery and radiotherapy,
* Description of the different treatment lines: number of cures, start and end date, response, toxicities,
* Status of the patient at the end of the study.

The number of subjects needed is calculated from observant patients. Based on the existing literature on adherence to chemotherapy or targeted oral therapy, the observed compliance rate is approximately 80%. However, since this characteristic is the object of this study and therefore not known ex ante, in the calculations of the sample size, the value allowing to obtain the lowest margin of error on the rate of compliance, an estimated prevalence of 50% compliance is used. By setting the risk of the first species at 5%, a confidence level of 95%, it is then necessary to include 132 patients.

In addition, given the difficulty inherent in the questionnaires in collecting all the information, 20% of the data was estimated not to be evaluable. It will therefore be necessary to include 158 patients in the study to reach our goal.

Safety and Compliance of Renal Cancer Patients Treated by Non-IV Drugs

Safety and Compliance of Patients Treated With Oral Route Anti Cancer Drugs.

Observance is first calculated via the use of the Morisky's score. The value of the score is between 0 and 4. The 0 corresponds to the absence of observance, the 4 to the perfect observance.

This score is completed by a question about drug delay (which measures poor compliance).

A subjective measure of compliance is also obtained from the patient's positioning of his compliance on a scale from 0 to 10. The value 0 corresponds to the fact that the person indicates that they do not comply at all with the treatment prescribed by the oncologist. Conversely, the value 10 corresponds to the exact respect of the treatment prescribed by the oncologist.

These two indicators are measured at different periods of treatment (1 month, 4 months ; 7 months and 10 months) via a patient questionnaire.

PFS (duration between treatment start and progression date) will be evaluated via medical records analysis.

Response rate will be evaluated via medical records analysis.

University of Angers, GRANEM

Fondation ARC

Institut Cancerologie de l'Ouest

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety Study of MPC-3100 in Cancer Patients Who Have Failed Other Treatments	NCT00920205	Cancer	MPC-3100 (an Hs...	18 Years -	Myrexis Inc.
Safety and Compliance of Renal Cancer Patients Treated by Non-IV Drugs	NCT03630692	Metastatic Rena... Stage III Renal...	observance of o...	18 Years -	Institut Cancerologie de l'Ouest

Spots Global Cancer Trial Database for oral drug

Every month we try and update this database with for oral drug 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 oral drug

Every month we try and update this database with for oral drug 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 oral drug 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.