Pharmacokinetic variability of paclitaxel in chemotherapy naïve cancer patients

Not Applicable

• Conditions: Health Condition 1: C00-D49- Neoplasms

• Registration Number: CTRI/2020/12/029534
• Lead Sponsor: All India Institute of Medical Sciences Rishikesh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

•All chemotherapy naïve patients of malignancy.

•Patients of malignancy planned to be treated with paclitaxel.

•Patients of malignancy considered fit for chemotherapy will be enrolled in this study

•Patients above 18 years of age

•Patients willing to provide written informed consent

Exclusion Criteria

•Deranged renal function (serum creatinine level >= 1.5 mg/dL),

•Concomitant radiotherapy for primary or metastatic sites;

•Any other drugs known to induce or inhibit CYP3A4 or CYP2C8 enzyme

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess interpatient variability of CYP2C8 and CYP3A4 activities in chemotherapy naïve cancer patients planned to be treated with paclitaxelTimepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
To assess adverse drug reactions in chemotherapy naïve cancer patients during paclitaxel infusion. <br/ ><br>Timepoint: 3 months;To assess interpatient pharmacokinetic variability of paclitaxel in chemotherapy naïve cancer patients. <br/ ><br>Timepoint: 3 months