A phase I trial of figitumumab in children with relapsed/refractory solid tumour

ISRCTN	ISRCTN12655440
DOI	https://doi.org/10.1186/ISRCTN12655440
Secondary identifying numbers	RG_09-071

Submission date: 19/01/2010
Registration date: 15/06/2010
Last edited: 04/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Kathy Pritchard-Jones
Scientific

The Institute of Cancer Research & Royal Marsden Hospital
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom

Phone	+44 (0)20 8661 3452
Email	kathy.pritchard-jones@icr.ac.uk

Study information

Study design	Phase I open-label multicentre study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A phase I open label multicentre trial of figitumumab, an insulin-like growth factor 1 receptor (IGFR-1R) antibody, in children aged 1 - 12 years old with relapsed/refractory solid tumour
Study acronym	FOREST
Study objectives	The aim of this study is to identify the maximum tolerated dose of figitumumab.
Ethics approval(s)	1. UK: Trent Research Ethics Committee pending as of 15/06/2010 2. France: pending as of 15/06/2010
Health condition(s) or problem(s) studied	Relapsed/refractory solid tumours
Intervention	Figitumumab given on day 1 of a three weekly cycle as a 2.5 hour intravenous (IV) infusion. Starting dose 6 mg/kg with escalation cohorts that include 10 mg/kg, 20 mg/kg and 30 mg/kg. In cycle one only, patients recieve a second identical loading dose given on day 2. Patients can receive up to 12 cycles of treatment providing there is clinical benefit. Follow up is up to 90 days after the last dose received or until the patient receives further therapy for their disease.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase I
Drug / device / biological / vaccine name(s)	Figitumumab
Primary outcome measure	Safety, measured by assessment of adverse events and laboratory abnormalities using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 assessing grade timing, seriousness and relatedness. Outcome will be measured after cycle 1.
Secondary outcome measures	1. Pharmacokinetic blood sampling looking at plasma figitumumab concentrations, anti-drug antibodies, serum IGF-1/2, insulin-like growth factor binding protein 3 (IGFCP-3), insulin and growth hormone levels, measured Cycle 1 day 1, 2 and 8 and then prior to cycle 4. Antidrug antibodies measured cycle 1 day 1 and end of treatment. 2. Response to treatment measured by Response Evaluation Criteria In Solid Tumours (RECIST) criteria or by nuclear imaging or histology, measured every 2 cycles
Overall study start date	01/08/2010
Completion date	01/08/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	1 Year
Upper age limit	12 Years
Sex	Both
Target number of participants	24 - 48 depending on the dose escalation required
Key inclusion criteria	1. Aged greater than 1 years and less than 12 years, either sex 2. Histological confirmation of solid extra cranial malignancy at original diagnosis 3. Phase 2 cohort only: measureable or clinically evaluable disease 4. Current disase status must be one for which no available curative therapy 5. Performance status Lansky greater than 50% or Eastern Cooperative Oncology Group (ECOG) less than 2 6. Adequate recovery from major surgery prior to treatment 7. No mitral valve regurgitation greater than trivial as determined by Doppler echocardiogram. Shortening of fraction less than or equal to 29%. Electrocardiogram (ECG) should be normal. 8. Must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy. Two weeks from previous chemotherapy, four weeks from previous radiotherapy and six weeks from previous nitrosureas or myeloablative chemotherapy. 9. Adequate bone marrow function 10. Adequate renal function 11. Adequate liver function 12. Males or females of reproductive potential may not participate unless they agree to use an effective contraceptive method 13. All patients and/or their parents or legal guardians must sign a written informed consent 14. Patients and/or their parents and/or legal guardians must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Key exclusion criteria	1. Concurrent treatment with any anti-tumour agents 2. Prior anti-IGF-1R therapy 3. Patients with symptomatic brain metastases 4. Significant active cardiac disease 5. Active infection 6. Poorly controlled Insulin-dependent diabetes mellitus 7. History of allergic reaction to immunoglobulin G (IgG) 8. Other severe acute or chronic medical or psychiatric condition
Date of first enrolment	01/08/2010
Date of final enrolment	01/08/2012

Locations

Countries of recruitment

England
France
United Kingdom

Study participating centre

The Institute of Cancer Research & Royal Marsden Hospital

Surrey
SM2 5PT
United Kingdom

Sponsor information

University of Birmingham (UK)
University/education

Research & Commercial Services
Aitchison Building
Edgbaston
Birmingham
B15 2TT
England
United Kingdom

Website	http://www.rcs.bham.ac.uk/
"ROR"	https://ror.org/03angcq70

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

04/10/2017: No publications found in PubMed, verifying study status with principal investigator.