Mitotane Therapeutic Drug Monitoring Study: Assessing Mitotane Pharmacodynamics in Adrenocortical Cancer in Children and Adults

Phase 4

Recruiting

• Conditions: Adrenocortical cancer; Cancer - Other cancer types

• Registration Number: ACTRN12613000058774
• Lead Sponsor: Calvary Mater Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Adrenocortical carcinoma, any stage.
2. Treating physician is of the opinion that Mitotane therapy is indicated for the patient
3. Normal haematological parameters
4. Normal liver function
5. Adequate renal function
6. Eastern Co-operative Oncology Group (ECOG) performance status 0-2 .
7. No other significant medical illness.
8. Geographically accessible and physically capable of completing study investigations as required.
9. Informed consent for study investigations.

Exclusion Criteria

none

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the relationship between plasma mitotane and metabolite levels and toxicity (as assessed clinically), and confirm the published relationship with response.[Continually from start until end of treatment period]

Secondary Outcome Measures

Name	Time	Method
To identify factors that account for variability in mitotane kinetics.<br>- we will correlate mitotane and metabolite pharmacokinetic (PK) parameters with phenotypic factors, including age, gender and body mass index. We anticipate that age, gender and body mass index will partly correlate with PK.[Continually from start until end of treatment period];Assess the role of mitotane metabolites in contribution to toxicity, by correlating plasma levels with clinical assessments[Continually from start until end of treatment period];To provide a precise mitotane therapeutic drug monitoring process that rapidly achieves trough levels in the range 14-20mg/L, by frequent, informed dose escalation. <br><br>[Continually from start until end of treatment period];To achieve Ideal plasma level as soon as possible (preferably within 4 weeks) after starting mitotane, and maintained without exceeding the ideal range[Continually from start until end of treatment period]