C28001 - MLN2480 patients with melanoma or solid tumour

• Research type

  Research Study

• Full title

  An Open-Label, Phase 1, Dose-Escalation Study of MLN2480 in Patients with Relapsed or Refractory Solid Tumors Followed by a Dose-Expansion Phase in Patients with Metastatic Melanoma

• IRAS ID

  118729

• Contact name

  Mark R Middleton

• Sponsor organisation

  Millennium: The Takeda Oncology Company

• Eudract number

  2012-003397-16

• Clinicaltrials.gov Identifier

  NCT01425008

• Research summary

  This is a phase 1, open label research study involving the first time MLN2480 will be given to humans. The main purposes of the study are to determine if MLN2480 is safe for human use and the efficacy of MLN2480 as an anti-cancer treatment. The study will be conducted in 2 phases; the Dose Escalation phase followed by the Dose Expansion phase. The Dose Escalation phase determines the maximum dose of MLN2480 that can be safely given to patients, diagnosed with a solid tumour that has either returned after a period of improvement or is not responding to standard cancer treatments. Approximately 96 melanoma patients are to be enrolled in the Dose Expansion phase in 20 hospitals worldwide, including the UK. The melanoma patients will be assigned to one of 6 groups (cohorts) depending on their treatment history and the genes in their tumour. A gene is a segment of DNA that determines particular characteristics e.g. eye colour. A 7th cohort, the PK (pharmacokinetics) cohort, will be made up of patients with an advanced solid tumour, who have failed standard cancer therapy or for whom no approved therapy is available. Pharmacokinetics is the study of the action of a drug over a period of time. Individual Dose Expansion cohorts may be opened or closed sequentially or in parallel at the sponsor’s discretion, based on emerging data. The Dose Expansion Phase will consist of three periods; screening, treatment and end of study. Each treatment period, “cycle”, will last 28 days and dosing of MLN2480 will occur on alternate days (14 doses). The only exception to this is the first cycle of the PK cohort, with 11 doses instead of 14 doses. A maximum study time of 12 months is recommended for each patient; however this can be extended if thought to benefit the patient. Alternatively, if the patient experiences negative side effects or disease progression, MLN2480 will be stopped earlier.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  13/SC/0007

• Date of REC Opinion

  7 Mar 2013

• REC opinion

  Further Information Favourable Opinion