Oraxol : A Randomized Crossover Study to Determine the Bioequivalence of Three Consecutive Daily Doses of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy | Breast,Female reproductive organs,Lung,Stomach and upper gastrointestinal tractBreast,Lung,Non-Small Cell Lung Cancer,Ovary,Stomach

Trial Overview Read MoreRead more

This phase I trial is comparing oral versus intravenous (IV) chemotherapy in patients for whom IV chemotherapy (paclitaxel 80mg/m2) has been recommended by their oncologist.
 

This trial is treating multiple types of cancer including those for which treatment with IV chemotherapy (paclitaxel 80mg/m2) has been recommended by an oncologist.

This is a systemic therapy trial.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Randomized Crossover Study to Determine the Bioequivalence of Three Consecutive Daily Doses of Oraxol in Cancer Patients Treated With Intravenous Paclitaxel

Commercial Sponsor

Kinex Pharmaceuticals Inc

Summary

This is a randomised, multicenter, open-label, 2-stage study. Both stages of the study have two treatment periods and a crossover design. The primary objective of the study is to compare the bioequivalence (BE) based on the AUC0-inf of orally administered paclitaxel (Oraxol) at the estimated clinical dose to that of IV paclitaxel.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
Early Phase Research Study Coordinator
earlyphase.oncresearch@monashhealth.org
0474 769 510

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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