A Randomized, Open Label Study Comparing the Combination of YONDELIS® and DOXIL®/CAELYX® with DOXIL®/CAELYX® Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

  • STATUS
    Recruiting
  • sponsor
    Janssen R&D LLC
Updated on 8 November 2020

Summary

A Randomized, Open Label Study Comparing the Combination of YONDELIS® and DOXIL®/CAELYX® with DOXIL®/CAELYX® Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Description

This is an open label study, active-controlled, multi-center study. The total duration of the study will be approximately 64 months. The screening phase may last up to 30 days. If the results of the procedures done during the screening period allow study participation, there will be randomization into 1 of 2 study groups. Group A will receive 20 mg dexamethasone to help prevent side effects of the combined chemotherapy, DOXIL®/CAELYX® which is the standard of care chemotherapy regimen to treat advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer, and trabectedin. Participants in Group B will only receive DOXIL®/CAELYX®. Treatment will be given in cycles in either 21 or 28 days depending on the group. In Group A, each cycle is 21 days and the participant will need to come to the study clinic on Days 1, 8, and 15. Study drug will be given on Day 1 of each cycle. In Group B, each cycle is 28 days and participants will need to come to the study clinic on Days 1, 8, 15, and 22. Study drug will be given on Day 1 of each cycle.

Details
Clinical Study IdentifierTX145692
SponsorJanssen R&D LLC
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Has a proven advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer
Has an Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
Received first-line treatment with a platinum-based regimen and had no evidence of disease progression for ≥ 6 months after the last dose
Received second-line treatment with a platinum-based regimen, with progression of disease after attaining a response
Progression of disease based on imaging after the second-line platinum-based regimen (individuals treated with a pegylated liposomal doxorubicin-containing regimen as a second-line therapy are eligible if subsequent disease progression occurs ≥ 9 months from the first dose)

Exclusion Criteria

Diagnosis of ovarian carcinoma with mucinous histology
Had more than 2 prior lines of systemic therapy. Maintenance therapies and hormonal therapies are not considered additional lines of therapy
Prior exposure to trabectedin or hypersensitivity to any of the excipients
Prior treatment with doxorubicin or other anthracycline at cumulative doses greater than 300 mg/m 2
Unwilling or unable to have a central venous catheter placed
Pregnant or breast-feeding
Would receive study drug within 3 weeks from radiation therapy, experimental therapy, hormonal therapy, prior chemotherapy, or biological therapy; use an invasive investigational device; or is currently enrolled in an investigational study
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note