Phase I Dose escalation study of Oral Phenoxodiol in combination with Cisplatin or Carboplatin in Patients with Advanced Malignancies

Phase 1

Completed

• Conditions: o change; No change; Cancer - Other cancer types

• Registration Number: ACTRN12605000453684
• Lead Sponsor: Marshall Edwards Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Patients meeting all of the following criteria will be considered for the study:a) Patients must have a malignancy that has progressed since treatment with at least one previous standard therapy, or where standard therapy for their disease has been refused, or where no standard therapy exists b) Patients must be able to understand the risks and benefits of the study and give written informed consent to participation. c) Patients must have an estimated life-expectancy of at least 3 months. d) Patients must have acceptable renal function as determined by a serum creatinine less than or equal to 0.15mmol/L. In addition, Glomerular Filtration Rate (GFR) as measured by isotope scan or by calculation using the Cockcroft Gault formula should be >40ml/min (Appendix I). acceptable hepatic function defined by serum transaminase levels less than or equal to 3 x the upper limit of normal for the reference laboratory. If tumour involves the liver, then transaminases should be less than or equal to 5 x the upper limit of normal are acceptable. Isolated hyperbilirubinemia (up to 2 x ULN) is acceptable adequate haematological function as defined by platelets > 100x109/L , WCC > 3x109/L, Hb > 10g/dL (>9g/dL for females), neutrophils > 1.5 x 109 /Lh) Patients of childbearing potential must agree to use an acceptable method of contraception.

Exclusion Criteria

Patients with any of the following will not be included in the study:a) Patients being treated concurrently with an investigational drug. Patients must be off treatment with any investigational agents for at least 3 weeks (patients may have had previous treatment with single agent phenoxodiol) provided all previous toxicity has resolvedb)Patients who are pregnant or lactatingc) Patients who have active, untreated infectiond)Patients who have active CNS metastases. Patients with known CNS metastases must have received prior surgery or radiation therapy, and CNS metastatic disease must be stable for at least 4 weeks prior to study entry.e)Patients who have breast cancer.f)Patients must have recovered from the effects of any prior anti-neoplastic therapy, and at least 3 weeks must have elapsed prior to study entryg)Patients who are on concurrent medications known to be metabolized by cytochrome P450 enzymes (Appendix E) may be excluded at the discretion of the investigator if assessed as being at high risk for significant drug interactions with phenoxodiol. Patients are not automatically excluded from this study however, simply because their concurrent medications includes any of those listed in Appendix E.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the recommended phase II dose of phenoxodiol in combination with cisplatin or carboplatin for further studies. [Measured on weekly basis (pharmacokinetics, safety, tumor markers) and every 3 months (CT scan). ]

Secondary Outcome Measures

Name	Time	Method
To determine the pharmacokinetic and safety profiles of phenoxodiol in combination with cisplatin or carboplatin. [Measured on weekly basis (pharmacokinetics, safety, tumor markers) and every 3 month (CT scan). ];To gain a preliminary indication of the anti-tumour activity of phenoxodiol when administered in combination with cisplatin or carboplatin. [Measured on weekly basis (pharmacokinetics, safety, tumor markers) and every 3 month (CT scan). ]