Monotherapy Dalotuzumab and Ridaforolimus-Dalotuzumab Combination Ther

• Research type

  Research Study

• Full title

  A Phase I Study of Monotherapy Dalotuzumab and Ridaforolimus-Dalotuzumab Combination Treatment in Paediatric Patients with Advanced Solid Tumours

• IRAS ID

  88080

• Contact name

  Andrew David Jones Pearson

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

• Eudract number

  2011-003407-38

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  BACKGROUND: This study is a companion to MK-8669 PN056, a Phase I Study of Ridaforolimus in paediatric patients (ages of 6 to <18 years) with advanced solid tumours .The study will evaluate the safety, tolerability, & pharmacokinetic (PK) parameters of oral ridaforolimus tablets. Data from PN056 will be used to inform the combination therapy dose selection for ridaforolimus in Parts 2 & 3 of this study. Dalotuzumab (MK-0646), an IGF-1R monoclonal antibody inhibitor, and ridaforolimus (MK-8669), a small molecule inhibitor of the mammalian target of rapamycin (mTOR), are currently in development for a variety of solid tumours. DESIGN A multi-centre, open-label Phase 1 dose-escalation trial of dalotuzumab (IV) and ridaforolimus to acquire safety, tolerability, and PK data for monotherapy dalotuzumab and combination treatment of ridaforolimus-dalotuzumab in children with advanced solid tumours. The study will be conducted in three parts: -Part 1 will be a dose escalation on dalotuzumab ONLY in patients with an age of 3 to less than 18 years old. -Part 2 will be dose escalation on ridaforolimus-dalotuzumab combination therapy. - Part 3 will be an expansion cohort of the combination therapy to further assessments and potential efficacy. Patients from 6 to <18 years old will be eligible for parts 2 and 3. Patients will be monitored carefully for the development of adverse experiences and for clinical and/or radiographic evidence of disease progression. There will be no intra-patient dose escalation for patients enrolled on this study. Patients will be treated until disease progression, unacceptable toxicity, or the withdrawal of consent, and will be treated thereafter at the discretion of the doctor.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  11/SC/0453

• Date of REC Opinion

  23 Jan 2012

• REC opinion

  Further Information Favourable Opinion