A Phase 1 Study of Deflexifol in patients with advanced malignancy after failure of standard treatment

Phase 1

Completed

• Conditions: Advanced Malignant Cancer; Cancer - Other cancer types

• Registration Number: ACTRN12619001533189
• Lead Sponsor: Detsamma Investments Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-06
• Study Completion: 2023-05-22
• Last Update Posted: 5 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Histologically or cytologically confirmed malignancy
2. Patients have metastatic or locally advanced disease, for which standard of care treatment has failed.
3. Age 18 or above
4. ECOG performance status of 0-2
5. Life expectancy of greater than 12 weeks
6. Satisfactory organ and marrow function as defined below: Satisfactory haematologic parameters: Hb>10g/dL, WBC>3.0, Platelets>100 Satisfactory hepatic function: Total Bilirubin less than 2 x ULN (upper limit of normal for the institution) (unless there is a documented history of Gilbert’s syndrome), AST <5xULN, ALT<5xULN, INR<1.5xULN, Satisfactory renal function: serum creatinine < 1.5xULN and calculated creatinine clearance > 35 ml/min. If female of childbearing potential , a negative pregnancy test
7. Female patients must agree to use contraception prior to entry to study for duration of study participation and for 90 days after the last dose of medication. Contraception must be highly effective with a failure of less then 1%.
8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

1. Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or the presence of adverse events due to agents administered more than 4 weeks earlier.
2. Known deficiency of dihydropyrimidine dehydrogenase (DPD)
3. History of severe reactions to 5-FU or fluoropyrimidines (Grade 3 or 4 CTC criteria)
4. Untreated brain metastases
5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Deflexifol including 5-FU, FA and ß-CD
6. Concurrent anti-cancer treatment is not permitted. However, supportive therapies such as bisphosphonates are allowed
7. Uncontrolled, inter-current illness including, but not limited to ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; transient ischemic attacks (TIA) or intermittent claudication; ventricular arrhythmias; atrial flutter or atrial fibrillation; pathologic sinus bradycardia (<60 bpm); heart block (excluding 1st degree block) or congenital long QT syndrome; or psychiatric illness/social situations that would limit compliance with study requirements
8. Pregnancy or breastfeeding
9. HIV-positive

Study & Design

• Study Type: Interventional
• Study Design: Not specified