Active not recruiting

A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer

I4T-MC-JVDC - ClinicalTrials.gov - NCT02426125

The main purpose of this study is to evaluate the safety and efficacy of the study drug ramucirumab in combination with docetaxel in participants with urothelial cancer who failed prior platinum-based therapy.
How long will I be in the trial?
Participation in this trial could last up to 12 months, depending on how you and your tumor respond
Email
Active not recruiting

A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer

I4T-MC-JVDC - ClinicalTrials.gov - NCT02426125

The main purpose of this study is to evaluate the safety and efficacy of the study drug ramucirumab in combination with docetaxel in participants with urothelial cancer who failed prior platinum-based therapy.
How long will I be in the trial?
Participation in this trial could last up to 12 months, depending on how you and your tumor respond
Email

Key Requirements

Age :

18+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participant must have urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis confirmed by histology or cytology

Participant must have disease progression while on a platinum containing regimen in the first-line setting or within 14 months after completing the first-line platinum regimen

Participant must be willing to provide blood, urine, and tissue samples for research purposes

Participants must NOT

Participant must not have received more than one prior systemic chemotherapy regimen for metastatic disease

Participant must not have received radiation therapy within 4 weeks (≤4 weeks) prior to first dose of study drug or has not recovered from toxic effects of the treatment that was given >4 weeks prior to first dose of study drug

Participant must not have a concurrent malignancy or had another malignancy within 5 years (≤5 years) of study enrollment

Participant must not have HIV infection or acquired immunodeficiency syndrome-related illness

Participant must not be pregnant or lactating

Trial Summary

Conditions the trial is for

Urothelial Cancer

What the trial is testing?

Ramucirumab, Docetaxel, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

524

Trial Dates

July 2015 - January 2021

Trial Phase

3

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

Participants must

Participant must have urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis confirmed by histology or cytology

Participant must have disease progression while on a platinum containing regimen in the first-line setting or within 14 months after completing the first-line platinum regimen

Participant must be willing to provide blood, urine, and tissue samples for research purposes

Participants must NOT

Participant must not have received more than one prior systemic chemotherapy regimen for metastatic disease

Participant must not have received radiation therapy within 4 weeks (≤4 weeks) prior to first dose of study drug or has not recovered from toxic effects of the treatment that was given >4 weeks prior to first dose of study drug

Participant must not have a concurrent malignancy or had another malignancy within 5 years (≤5 years) of study enrollment

Participant must not have HIV infection or acquired immunodeficiency syndrome-related illness

Participant must not be pregnant or lactating

Trial Summary

Conditions the trial is for

Urothelial Cancer

What the trial is testing?

Ramucirumab, Docetaxel, Placebo

Could I receive a Placebo?

yes

Enrollment Goal

524

Trial Dates

July 2015 - January 2021

Trial Phase

3

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Trial Locations

Hide locations not currently recruiting

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Urothelial Cancer Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?