Contact information
Type
Scientific
Contact name
Prof Kathy Pritchard-Jones
ORCID ID
Contact details
The Institute of Cancer Research & Royal Marsden Hospital
Downs Road
Sutton
Surrey
SM2 5PT
United Kingdom
+44 (0)20 8661 3452
kathy.pritchard-jones@icr.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
RG_09-071
Study information
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
Acronym
FOREST
Study hypothesis
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
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
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Overall study end date
01/08/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
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
Participant 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
Recruitment start date
01/08/2010
Recruitment end date
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
Organisation
University of Birmingham (UK)
Sponsor details
Research & Commercial Services
Aitchison Building
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) Intention to share
No
IPD sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|