Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Lynne Bui


Contact details

2100 Powell Street
United States of America

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A phase I, open-label, dose-finding study to evaluate the safety and pharmacokinetics of ONX 0801, a novel alpha-folate receptor-mediated thymidylate synthase inhibitor, in patients with advanced solid tumours


Study hypothesis

Is ONX 0801 tolerable and safe in cancer patients and can a dose be identified which inhibits tumour cell growth in future clinical studies?

Ethics approval

Royal Marsden Hospital Ethics Committee and the Hammersmith Ethics Committee – submission pending, planned for June 2009

Study design

Phase I open-label dose-finding study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details provided in the interventions section to request a patient information sheet


Advanced solid tumours


Cohorts of 3 to 6 patients will receive ONX 0801 at escalating doses until a maximum tolerated dose (MTD) is determined. Each patient will receive a 3-hour intravenous (IV) infusion of ONX 0801 weekly (i.e., on days 1, 8, and 15) of repeated 21-day treatment cycles.

Contact details for patient information material:
Udai Banerji, MD, MRCP, PhD
Clinical Senior Lecturer
Section of Medicine
Institute of Cancer Research
The Royal Marsden Hospital
15 Cotswold Road
Sutton, UK SM2 5NG
+44 (0) 20 8661 3993

Intervention type



Phase I

Drug names

ONX 0801

Primary outcome measure

1. To determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of ONX 0801 based on dose limiting toxicities (DLTs) occurring within cycle 1
2. To characterise the safety profile of ONX 0801

Secondary outcome measures

1. Pharmacokinetics (PK) of ONX 0801:
Blood samples will be collected according to the following schedule:
1.1. Cycle 1, Day 1: predose and 30 minutes and 1, 2, 3, 3.5, 4, 6, 8, 12, 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours following the start of the infusion
1.2. Cycle 1, Days 8 and 15: predose and 3 hours following the start of the infusion
1.3. Cycle 2, Days 1 and 8: predose and 3 hours following the start of the infusion
2. Pharmacodynamics of ONX 0801:
2.1. Blood samples will be collected according to the following schedule: predose and 4, 8, 24 (Day 2), 48 (Day 3), and 72 (Day 4) hours following the start of infusion in Cycle 1, Day 1 and approximately every 6 - 9 weeks during the course of the study
2.2. Tissue samples may be collected predose and up to 72 hours following the start of the infusion in Cycle 1, Day 1
2.3. 18FLT-PET scans may be performed predose and between 16 to 48 hours following the start of the infusion in Cycle 1, Day 1
3. Identifying a biologically effective dose (BED) equal to or lower than the MTD and/or RP2D of ONX 0801
4. Assess the preliminary antitumour activity of ONX 0801

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Histologically or cytologically proven solid tumours, including lymphomas. Patients must have disease which has failed standard therapy or for which no standard curative therapy exists.
2. Greater than or equal to 18 years of age, either sex
3. Eastern Cooperative Oncology Group performance status (ECOG PS) less than or equal to 2
4. Life expectancy greater than or equal to 12 weeks
5. Measurable (as defined by Response Evaluation Criteria in Solid Tumours [RECIST version 1.1]) or evaluable (based on radiological assessments or tumour markers) disease
6. Recovered (i.e., to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Version 3.0 Grade less than or equal to 1) from all toxicities associated with previous chemotherapy or radiotherapy (exception: patients may enter with continuing alopecia irrespective of CTCAE grade). The following intervals between starting last treatment and starting ONX 0801 must elapse:
6.1. Chemotherapy (see exception below): at least 4 weeks
6.2. Mitomycin C or a nitrosourea: at least 6 weeks
6.3. Targeted therapy: at least 2 weeks or 2 half-lives, whichever is longer
6.4. Biologics: at least 4 weeks
6.5. Radiotherapy: at least 4 weeks
7. Normal organ function
8. Normal electrocardiogram (ECG)
9. Archival tumour tissue available

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Pregnant women, women who are lactating, or women of childbearing potential who are not currently on effective means of birth control
2. History of QT/QTc prolongation, clinically significant ventricular tachycardia, ventricular fibrillation, heart block, myocardial infarction within 1 year, congestive heart failure New York Heart Association Class III or IV, unstable angina, angina within 6 months, or other evidence of clinically significant coronary artery disease
3. Active, ongoing infection, including viral hepatitis
4. Undergone major surgery within the last 4 weeks
5. Organ transplant recipients
6. New brain metastasis. Patients with treated (surgically excised or irradiated) and stable brain metastases are eligible as long as the treatment was at least 4 weeks prior to initiation of study drug and baseline brain computed tomography (CT) with contrast or magnetic resonance imaging (MRI) within 2 weeks of initiation of study drug is negative for new brain metastases.
7. Patients who have been on other experimental clinical trials of investigational agents within the last 28 days

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

2100 Powell Street
United States of America

Sponsor information


Onyx Pharmaceuticals (USA)

Sponsor details

2100 Powell Street
United States of America

Sponsor type




Funder type


Funder name

Onyx Pharmaceuticals (USA)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

For-profit companies (industry)


United States of America

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

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/12/2017: No publications found in PubMed, verifying study status with principal investigator.