Phase I accelerated dose-escalation study of CYT997 given as an oral capsule every two weeks in patients with advanced solid tumours

Phase 1

Completed

• Conditions: Cancer - solid malignancies that are metastatic or unresectable; Cancer - Other cancer types

• Registration Number: ACTRN12606000520538
• Lead Sponsor: Cytopia Research Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-12-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

(i) Confirmed solid malignancy; (ii) Life-expectancy of greater than 3 months; (iii) No anticancer chemotherapy or hormonal therapy for the preceding 4 weeks; (iv) Adequate organ and marrow function.

Exclusion Criteria

(i) Patients must not have received other experimental agents in preceding 4 weeks; (ii) Known brain metastases; (iii) Patients with various cardiovascular risk factors are excluded; (iv) Pregnancy and immune deficiency.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of CYT997 following oral administration. For an adverse event to qualify as a dose-limiting toxicity it must occur in the first cycle of therapy (for each patient). Dose-escalation ceases when an adverse event which qualifies as a DLT occure in the first cycle of a given dose level and, in accordance with the protocol, further patients are enrolled at this dose level until the sooner of a second DLT or 6 patients are enrolled in total. When a second DLT does occur, no further patients are enrolled at this dose and the MTD is determined. Further patients may be enrolled at the previous dose level to define the recommended dose for Phase II studies.[DLTs are assessed throughout the first cycle and the MTD is determined when two or more DLTs occur at a particular dose level.]

Secondary Outcome Measures

Name	Time	Method
(i) To study the pharmacokinetics of CYT997 following oral administration[After dose administration in the first and second cycles];(ii) To characterise the toxicities and tolerability of CYT997 following oral administration[Continuously throughout the study];(iii) To define a recommended dose for oral Phase II studies [Following determination of the MTD];(iv) To make a preliminary evaluation of anti-tumour activity[After every second cycle of drug];(v) To make a preliminary evaluation of vascular-targetting activity[From data acquired during the first cycle];(vi) To assess pharmacokinetic/pharmacodynamic relationships[From data collected in the first cycle]