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Anti-tumor antibiotic

Treatment A: DOXIL/CAELYX (doxorubicin) for Constipation

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to cycle 3 day 1
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

The purpose of this study is to support the qualification of a replacement manufacturing site for DOXIL/CAELYX (doxorubicin HCL).

Eligible Conditions
  • Breast cancer
  • Constipation
  • Tumors
  • Ovarian Neoplasms
  • Solid Malignancies

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to cycle 3 day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to cycle 3 day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Response

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment B: DOXIL/CAELYX (doxorubicin)Experimental Treatment2 Interventions
50 mg/m2 of doxorubicin manufactured at the new site of manufacturing (test product) administered by IV infusion over 90 minutes on Day 1
Group II: Treatment A: DOXIL/CAELYX (doxorubicin)Experimental Treatment2 Interventions
50 mg/m2 of doxorubicin manufactured at the current site of manufacturing administered by IV infusion over 90 minutes on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
FDA approved
Doxorubicin
FDA approved

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
993 Previous Clinical Trials
6,387,019 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
759 Previous Clinical Trials
3,962,759 Total Patients Enrolled
~4 spots leftby Oct 2025
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