Zoledronic acid in the management of Mesothelioma - a feasibility trial

Phase 1

• Conditions: Malignant pleural mesothelioma; MedDRA version: 19.0 Level: PT Classification code 10027406 Term: Mesothelioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0 Level: PT Classification code 10035603 Term: Pleural mesothelioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0 Level: PT Classification code 10059518 Term: Pleural mesothelioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004433-26-GB
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-17
• Study Completion: 2018-07-24
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

-Histo-cytologically confirmed diagnosis of MPM
-WHO performance status 0-1
-Eligible for first line chemotherapy treatment
-Measurable disease on CT as per modified RECIST criteria (tumour thickness >5mm)
-Ability to give informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

Not fit for chemotherapy due to performance status or other comorbidities
Previous chemotherapy for MPM
IV bisphosphonates in the 3 months preceding randomisation
Significant renal disease (eGFR < 30ml/min in the last 4 weeks)
Hypocalcaemia (current hypocalcaemia on treatment, evidence of hypocalcaemia on most recent blood tests – should be within the last 6 weeks)
Known allergy to bisphosphonates or excipients of its preparation
Severe untreated dental caries
Concomitant participation in another drug trial for mesothelioma
Allergy to 18-Fluodeoxyglucose used for the PET scan
Women of child bearing potential (defined as fertile, or following menarche and until becoming post-menopausal unless permanently sterile)

Study & Design

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