Condition category
Cancer
Date applied
19/01/2010
Date assigned
15/06/2010
Last edited
27/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 number

ClinicalTrials.gov number

Protocol/serial number

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

To identify the maximum tolerated dose of figitumumab.

Ethics approval

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

Trial setting

Hospitals

Trial 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

Phase

Phase I

Drug names

Figitumumab

Primary outcome measures

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 trial start date

01/08/2010

Overall trial end date

01/08/2012

Reason abandoned

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

Patient

Age group

Child

Gender

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

France, United Kingdom

Trial 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
United Kingdom

Sponsor type

University/education

Website

http://www.rcs.bham.ac.uk/

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

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes