Phase Ia Safety and Pharmacokinetic Study of Oral NV-196 in Patients with Solid Tumours

Phase 1

Completed

• Conditions: Solid tumors; Patients with solid tumors; Cancer - Other cancer types

• Registration Number: ACTRN12606000345583

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Patients meeting all of the following criteria will be considered for admission to the study:a)Patients must have a solid malignancy that has become stable on current treatment. For the purposes of this study, stable disease is defined as no change of anti-cancer therapy within the last 28 days (hormone therapy or on observation), not including supportive therapies. Patients just completing chemotherapy or radiotherapy are eligible, provided these treatments were last administered more than 28 days prior to NV-196 administration.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 and hepatic function evidenced by a serum creatinine < 1.5 mg/dl and serum transaminase levels less than or equal to 3 x the upper limit of normal for the reference laboratory •bilirubin < 20 micro mol/L,•adequate haematological function. e)Patients must have a Karnofsky Performance Score of at least 60%. f)Patients of childbearing potential must agree to use an acceptable method of contraception. g)Patients have no evidence of central nervous system malignancy.

Exclusion Criteria

Patients presenting with any of the following will not be included in the study:a)Patients who are on a concurrent investigational drug study or who have had any treatment with any investigational agents within 4 weeks of commencing the study.b)Patients with active infection.c)Patients who have not recovered from the acute effects of any prior anti-neoplastic therapy or radiotherapy.d)Patients who, in the opinion of the investigator, are more suitable for active treatment with an anti-cancer agent.e)Patients with concurrent severe and/or uncontrolled medical disease (eg. uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure, etc.).f)Patients with a history of chronic active hepatitis or liver cirrhosis.g)Patients with HIV.h)Patients who are pregnant or lactating.

Study & Design

• Study Type: Interventional
• Study Design: Not specified