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Pharmacokinetic variability of paclitaxel in chemotherapy naïve cancer patients

A cross-sectional study on impact of CYP2C8 and CYP3A4 activity on pharmacokinetic variability of paclitaxel in chemotherapy naïve cancer patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029534
Enrollment
20
Registered
2020-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

Intervention1: Paclitaxel: The patients will be administered paclitaxel as per standard chemotherapy protocol according to age, diagnosis, Chemotherapy treatment schedule as for example, For Carcinoma

Sponsors

All India Institute of Medical Sciences Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
To assess adverse drug reactions in chemotherapy naïve cancer patients during paclitaxel infusion. Timepoint: 3 months;To assess interpatient pharmacokinetic variability of paclitaxel in chemotherapy naïve cancer patients. Timepoint: 3 months

Countries

India

Contacts

Public ContactDr Puneet Dhamija

All India Institute of Medical Sciences, Rishikesh

puneet.phar@aiimsrishikesh.edu.in8475000292

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026