A phase I study to evaluate the safety and pharmacokinetics of ONX 0801 in advanced solid tumours

Phase 1

Completed

• Conditions: Cancer; Advanced solid tumours; Malignant neoplasm of other and ill-defined sites

• Registration Number: ISRCTN79302332
• Lead Sponsor: Onyx Pharmaceuticals (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-30
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified