Mesothelioma Stratified Therapy (MiST): A multi-drug phase II trial in malignant mesothelioma

Phase 2

• Conditions: Mesothelioma; Cancer

• Registration Number: ISRCTN39816629
• Lead Sponsor: niversity of Leicester

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33515503/ MiST1 (added 28/06/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35157829/ MiST2 (added 28/06/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-01
• Last Update Posted: 12 September 2022
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Pre-screening:
1. Histologically confirmed MM with an available biopsy for research purposes
2. Aged 18 years or older
3. Expected survival of =12 weeks or greater
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
5. CT scan of chest and abdomen (and pelvis if applicable) confirming disease progression
6. Received at least one prior line of therapy to include a platinum doublet first-line chemotherapy (within or outside of another clinical trial)
7. Willing to consent for molecular screening of archived tumour block (PIS1 & CF1)
Each individual MiST drug protocol contains the eligibility criteria specific to the treatment allocated to the patient and these are yet to be finalised.

Exclusion Criteria

Pre-screening:
1. Diagnosis of a second malignancy except prostate or cervical cancer in remission, or a diagnosis of basal cell carcinoma of the skin or superficial bladder cancer
2. Uncontrolled CNS disease (asymptomatic brain metastases are allowed if previously treated with radiotherapy >28 days prior to starting the investigational agent)
3. New York Heart Association Class II or greater congestive heart failure
4. Severe hepatic insufficiency or severe renal impairment
5. Requiring long term oxygen therapy.
6. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease control rate (DCR) after 12 weeks, assessed using modified RECIST 1.1 criteria with CT scan evidence. Scans will be undertaken every 6 weeks and analysis will be timed from study entry using the baseline CT scan results until completion of the treatment cycles, confirmed disease progression or death (whichever occurs first)