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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12606000345583
• Date of registration: 11/08/2006
• Prospective Registration: No
• Public title: Phase Ia Safety and Pharmacokinetic Study of Oral NV-196 in Patients with Solid Tumours
• Scientific title: Phase Ia Safety and Pharmacokinetic Study of Oral NV-196 in Patients with Solid Tumours
• Date of first enrolment: 01/08/2006
• Target sample size: 12
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12606000345583.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Pharmacokinetics;
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: Ken Musgrave

• Name: Ken Musgrave

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: Not stated
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Solid tumors;Patients with solid tumors;
Solid tumors
Patients with solid tumors

Cancer - Other cancer types

Intervention(s)

NV-196 capsules -oral dosage formulation
There is no dose increments. We have acute dosing and chronic dosing.
Acute dosing on day 1- 100 mg once a day
Chronic dosing starts on day 3 up to day 8 in the morning. On days 3 to 7 - patients will have 100 mg three times per day and on day 8 the last dose - 100 mg only in the morning.

Primary Outcome(s)

a) to determine the safety and tolerability of repeated doses of oral NV-196 in patients with solid tumours.
The study is 9 days long . [The outcomes will be monitored on days 1,2,5,8 and 9 and there will be a follow- up visit 28 days from last dose.]

b)to determine the pharmacokinetics of NV-196 and its metabolite NV-143 after single and multiple oral dosing in patients with solid tumours.
The study is 9 days long .[The outcomes will be monitored on days 1,2,5,8 and 9 and there will be a follow- up visit 28 days from last dose.]

Secondary ID(s)

Marshall Edwards Pty Ltd: NV196-0001

Source(s) of Monetary Support

The same name

Ethics review

Status: Approved
Approval date:
Contact:

Mater Hospital