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Trial Details
Trial status:
Closed
Recruitment start date:
19/08/2013
Funder:
Aldeyra Therapeutics (previously Madrigal Therapeutics; formerly Synta Pharmaceuticals)
Sponsor:
UCL
Chief Investigator:
Professor Dean Fennell
Recruitment target:
27 patients recruited into phase I
EudraCT number:
2012-001598-10
Contact details:
ctc.meso-02@ucl.ac.uk
Lay summary:
MESO-02
A phase I/II study of first line ganetespib with pemetrexed/Cisplatin in patients with malignant pleural mesothelioma
Description
Design:
A phase I/II study of first line ganetespib with pemetrexed-platinum in patients with malignant pleural mesothelioma. Phase I follows a 3+3 dose escalation design (cisplatin patients) and an accelerated titrated design (carboplatin patients) to find the maximum tolerated dose (MTD) of ganetespib out of three dose cohorts (100, 150 or 200mg/m2) administered. Phase II will be a multicentre randomised trial of pemetrexed-platinum with ganetespib using the MTD identified in Phase I.


Treatment: In phase I, all patients in each dose cohort will receive six cycles of ganetespib with chemotherapy (pemetrexed with cis-or carboplatin), followed by maintenance ganetespib. Each cycle lasts 21 days. The first dose cohort will receive 100mg/m2 ganetespib. Subsequent cohorts (150 or 200mg/m2) will not start until all patients in the previous cohort have completed at least 2 cycles and been assessed for dose limiting toxicities (DLT) in cycles 1 and/or 2. In phase II, patients will be randomised to receive either ganetespib at the MTD with chemotherapy followed by maintenance therapy, versus chemotherapy only.
Key inclusion/exclusion criteria: Chemotherapy naïve, histopathological confirmation of malignant pleural mesothelioma, measurable disease using meso-modified RECIST criteria. Prior exposure to other investigational or commercial agents or therapies administered with the intent of treating the patient’s malignancy, or evidence of CNS metastases are not permitted.
Duration of recruitment: Recruitment into phase I has ended (N=27). 

The trial will no longer proceed to the randomised phase II following the business decision by the drug company to cease development of ganetespib in this population.
Aim
The overall aim of the phase I part of the trial is to establish the maximum tolerated dose of ganetespib and the number of chemotherapy cycles administered.  This will be used to determine the most appropriate dose of ganetespib in phase II.

The phase II will explore whether the addition of ganetespib to pemetrexed-platinum improves progression free survival. Secondary aims are to examine whether ganetespib affects tumour response rate, overall survival, or toxicity.



Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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