Monotherapy Dalotuzumab and Ridaforolimus-Dalotuzumab Combination Therapy

Phase 1

• Conditions: advanced solid tumors including lymphoma and tumors of the central nervous system; MedDRA version: 14.0 Level: LLT Classification code 10065143 Term: Malignant solid tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-003407-38-FR
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-11-18
• Study Completion: 2013-09-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

•Male or female age 6 to 17 years (included) on day of signing informed consent are eligible for Parts 1-3 of this study. Additionally, children ages 3 to 5 years are eligible for treatment in the dalotuzumab monotherapy dose escalation cohort (Part 1).
•Histologic or cytologic diagnosis of a malignant solid tumor, including tumors of the central nervous system and lymphoma that have progressed despite standard therapy or for which no effective standard therapy is known.
•Patient must be able to swallow tablets. (Patients to be enrolled into Parts 2 & 3).
•Performance Status: Lansky Play Scale =70 for children <10 years of age; Karnofsky score =70 for children =10 to <16 years; or ECOG Status 0-2 for patients age 16 and older.
•Patient has a Body Surface Area (BSA) that allows evaluation of the current dose level. (For Ridaforolimus-containing Parts 2 and 3 only)
•For females of reproductive potential, a negative pregnancy test must be documented within 72 hours of receiving the first dose of study medication.

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients currently receiving any other investigational agents or using any investigational devices.
•Patients with leukemia.
•Patients who have previously received dalotuzumab or other IGF-1R inhibitors (Part 1).
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to dalotuzumab (Patients to be enrolled into Parts 1-3) or ridaforolimus (Patients to be enrolled into Parts 2-3).
•Patient has persistent acute toxicity from previous therapy = Grade 2 by NCI CTCAE Version 4 (excluding alopecia, neuropathy, or hearing loss).
•Uncontrolled intercurrent illness.
•Pregnancy or females who are breastfeeding.
•Patients to be enrolled into Parts 2-3 only: Patient has a requirement for concurrent treatment with medications that are inducers or inhibitors of cytochrome P450 (CYP3A). Patients should be off these medications for at least 2 weeks prior to the first dose of ridaforolimus.
•Patient has poorly controlled Type 1 or 2 diabetes, defined as a fasting glucose >160 mg/dL.

Study & Design

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