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To Assess the Bioavailability and Safety of Paclitaxel Injection Concentrate for Suspension in Subjects With Locally Recurrent or Metastatic Breast Cancer

NCT04332549 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-06-01

No results posted yet for this study

Summary

A randomized, multi center, open label, two-period, single dose, crossover study to evaluate the bioavailability and safety of Paclitaxel Injection Concentrate for Suspension in Locally Recurrent or Metastatic Breast Cancer subjects.

Conditions

Interventions

DRUG

PICS (Reconstitution Method 1 or 2)

dose: 260mg/m2 Frequency: 2 period cross over study Route of administration : intravenous infusion duration of therapy: 2 cycles of PICS

Sponsors & Collaborators

  • Sun Pharma Advanced Research Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-27
Primary Completion
2021-01-28
Completion
2021-01-28
FDA Drug
Yes

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04332549 on ClinicalTrials.gov