The use of a new technique (signal transduction pathway activity measurements) for the selection of ovarian cancer patients for targeted therapy.

Phase 1

• Conditions: Ovarian cancer; MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10057529Term: Ovarian cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10033131Term: Ovarian carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10070905Term: Ovarian cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10070906Term: Ovarian cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10070907Term: Ovarian cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10070908Term: Ovarian cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10007107Term: Cancer of ovarySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2020-005091-36-NL
• Lead Sponsor: Stichting Catharina Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-18
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 146

Inclusion Criteria

-Age > 18 years.
-Patients with recurrent ovarian cancer who meet one of the following criteria:
oPlatinum-resistant disease or;
oPatients refrains from standard therapy or;
oAsymptomatic patients who are not yet eligible for standard palliative chemotherapy but have an increase of CA125 tumour marker at two consecutive timepoints 28 days apart with a value of two times nadir above 35 U/ml).
-Progressive disease after at least one prior line of systemic treatment for recurrent disease.
-Radiologically evaluable disease according to RECIST 1.1 criteria.
-Ability and willingness to obtain a tumour biopsy after the last course of standard treatment and before start of the study.
-Ability and willingness to provide written and oral consent.
-Able to speak and understand the Dutch language.
-WHO performance status 0-II.
-Adequate renal and liver function to start matched targeted therapy (according to the local clinician).
-Adequate use of contraceptives in case of patients with childbearing potential.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 115

Exclusion Criteria

-Age < 18 years.
-Patient is receiving any other anti-cancer therapy (e.g. cytotoxic or targeted drug or radiation) or is chemotherapy naïve. The required wash out period prior to start of matched targeted therapy is at least three weeks.
-Patient is diagnosed with or treated for a second primary tumour (except non-melanoma skin tumour) one year prior to study inclusion.
-Inability to obtain (sufficient) tumour material.
-Previous use of the selected targeted drug as anti-cancer agent.
-Physical condition WHO III-IV.
-Pregnant or lactating women.
-Simultaneous participation in another treatment-related clinical trial.
-Patients with any other clinically significant medical condition which, in the opinion of the local clinician, makes it undesirable for the patient to participate in this study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, severe psychiatric illness, or complicated social situations.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified