Signal Transduction Analysis in OVarian cancER (STAPOVER)
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|ClinicalTrials.gov Identifier: NCT03458221|
Recruitment Status : Not yet recruiting
First Posted : March 8, 2018
Last Update Posted : March 13, 2018
PROBLEM DEFINITION/OBJECTIVE: Ovarian cancer is the 5th most lethal cancer in the world due to the fact that tumours are detected at late stage of disease, currently without curative therapies at that stage. Standard therapy consists of surgery and chemotherapy. Despite this aggressive treatment overall five year survival is only 30%. Tumors are driven by cellular signal transduction (ST) pathways. Identifying activity of these pathways in cancer tissue can be used to choose an appropriate targeted drug. A number of targeted therapy drugs have become available, or are being developed that target individual ST pathways. Identification of the predominant ST pathway in cancer has shown to be extremely difficult. A newly developed reliable mRNA analysis technique (STAnalysis) is able to assess which pathway/s is/are active indicating which targeted therapy is deemed to be effective.
STUDY DESIGN: A multicentre prospective cohort study. STUDY POPULATION: Patients with platinum-refractory/resistant or recurrent ovarian cancer.
DIAGNOSTIC INTERVENTION & COMPARATOR: Analysis of the prevalent ST pathway and targeted therapy towards this pathway.
OUTCOME MEASURES: Increase in survival.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Carcinoma Signal Transduction Pathway Deregulation Therapy-Associated Cancer||Drug: Itraconazole||Phase 3|
Rationale: Ovarian carcinoma is one of the most lethal cancers in the world due to the fact that tumors are detected at late stage of disease, without curative therapies at that stage. Standard therapy consists of debulking surgery and platinum-paclitaxel containing chemotherapy. Despite this aggressive treatment five year survival is approximately 30%. Recently, it has been shown that tumor growth is driven by Signal Transduction Activation (STA) pathways. Twelve such pathways are known and in most tumours only one of these pathways is predominant. A number of "targeted therapy" drugs have become available, or are being developed that target individual STA pathways. Furthermore, a newly developed technique is able to assess which pathway is predominant in (ovarian) cancer. Therefore, specifically targeting the predominant pathway might impair tumor growth and might improve survival.
Objective: This study aims to evaluate the effectiveness of targeted therapy, as defined by STA pathway analysis, in patients with recurrent ovarian carcinoma.
Study design: Intervention study. Study population: Adult women with histologically/cytologically proven ovarian carcinoma who are group A: without symptoms and would normally await palliative chemotherapy until symptoms and group B: with symptoms, who are eligible for palliative chemotherapy.
Intervention (if applicable): STA pathway analysis will be performed on histological biopsies taken from the tumor. Targeted drugs against the predominant pathway will be used against the predominant pathway. Initially we will start with targeted therapy in patients with either HH positive or ER positive tumors, since targeted therapy towards these pathways are easily available (itraconazole / tamoxifen) with little known side effects. For other targeted therapies approval will be asked separately.
Main study parameters/endpoints: Response of tumour growth/regression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||on the basis of primary Signalling Transduction Pathway Activation 'targeted therapy' will be administered to ovarian carcinoma patients|
|Masking:||None (Open Label)|
|Official Title:||Signal Transduction Analysis in OVarian cancER|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||August 1, 2022|
|Estimated Study Completion Date :||December 1, 2022|
U.S. FDA Resources
Experimental: itraconazole / tamoxifen
In case of HedgeHog pathway positivity itraconazole will be administered in case of ER pathway positivity tamoxifen will be adminisered
based on the predominant Signal transduction pathway analysis 'targeted therapy' will be administered
Other Name: tamoxifen
- survival benefit [ Time Frame: 4 months or more ]months gained by adding 'targeted therapy' drugs
- QOL [ Time Frame: pre treatment and 1, 3, 4 and 6 months after treatment start ]quality of Life in the group of patients treated with 'targeted therapy' by EORTC QLQ-C30 questinaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458221
|Contact: Jurgen M Piek, MD, PhD||+31(0)40 239 91 firstname.lastname@example.org|
|Contact: Ruud Bekkers, MD, PhD||+31(0)40 239 91 email@example.com|
|Catharina Ziekenhuis||Not yet recruiting|
|Eindhoven, Brabant, Netherlands, 5623EJ|
|Contact: Jurgen M Piek, MD. PhD. +31(0)40 239 9111 firstname.lastname@example.org|
|Radboudumc||Not yet recruiting|
|Nijmegen, Gelderland, Netherlands|
|Contact: L Massuger, Prof email@example.com|
|Erasmus MC||Not yet recruiting|
|Contact: I Boere, MD., PhD. firstname.lastname@example.org|