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Clinical Trials List

Protocol NumberI4T-MC-JVDC
NCT Number(ClinicalTrials.gov Identfier)NCT02426125

2015-06-22 - 2019-06-30

Phase III

Terminated7

ICD-10C66.2

Malignant neoplasm of left ureter

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab plus Docetaxel Versus Placebo plus Docetaxel in Patients with Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

    Eli Lilly and Company

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Yu-Li Su Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 歐宴泉 Division of Urology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 林建良 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wen-Pin Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

CRO

Principal Investigator Su-Peng Yeh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Yen-Hwa Chang Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Su-Peng Yeh 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma

Objectives

The primary objective of this study is to compare the progression-free survival (PFS) of ramucirumab in combination with docetaxel with the PFS of placebo in combination with docetaxel, in patients with locally advanced or unresectable or metastatic urothelial carcinoma who have had disease progression on or after one prior first-line platinum-based chemotherapy.

Test Drug

Ramucirumab (Cyramza)

Active Ingredient

Ramucirumab

Dosage Form

Injection

Dosage

500 mg/ 50 mL (10 mg/mL)

Endpoints

Efficacy:
PFS is defined as the time from the date of randomization to the date of first observation of objective progression
as defined by RECIST 1.1 or the date of death due to any cause, whichever is earlier.
OS is defined as the time from the date of randomization to the date of death from any cause.
ORR is defined as the proportion of randomized patients achieving a best response of CR or PR, using the
investigator response assessments.
DCR is defined as the proportion of randomized patients achieving a best response of CR, PR, or stable disease
(SD). SD is defined per RECIST criteria and must last a minimum of 5 weeks from randomization.
DOR is defined only for responders (patients with CR or PR [confirmation not required]) and is measured from the
date of first evidence of CR or PR to the date of objective progression or the date of death due to any cause,
whichever is earlier.
Safety: Drug exposure; adverse events (AEs); treatment-emergent adverse events (TEAEs); deaths; serious
adverse events (SAEs); other significant AEs (including TEAEs leading to study treatment discontinuations and
dose modifications); vital signs; transfusions; other observations related to safety; and clinical laboratory
evaluations. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA®
). AEs and
clinical laboratory values will be graded using the National Cancer Institute Common Terminology Criteria for
Adverse Events (CTCAE), Version 4.0 (v 4.0).
Health Outcomes: Assessment of PROs will be conducted through the use of the EORTC QLQ-C30 and the
EQ-5D-5L questionnaires, which measure quality of life and health status, respectively. A change of ≥10 points on
the 100-point EORTC QLQ-C30 scales is considered clinically meaningful.

Inclution Criteria

Key Inclusion Criteria
 The patient has histologically or cytologically confirmed, locally advanced or unresectable or metastatic
urothelial (transitional cell) carcinoma of the bladder, urethra, ureter, or renal pelvis. Patients with mixed
pathology are eligible only if they have predominantly transitional cell tumor based on local pathology
review.
 The patient has demonstrated disease progression while on a platinum-containing regimen in the first-line
setting or within 14 months of completing the first-line platinum regimen. Patients who received
treatment with one immune checkpoint inhibitor (for example, PD-1, PDL1, or CTLA4) regimen
following platinum therapy may have a longer interval since prior platinum-containing therapy
(≤24 months); such patients are eligible.
 The patient has received no more than one prior systemic chemotherapy regimen in the relapsed or
metastatic setting. Prior cytotoxic therapy in an adjuvant or neoadjuvant setting is not considered as a
prior line of systemic chemotherapy in the relapsed or metastatic setting. Prior treatment with
intravesicular chemotherapy, bacillus Calmette-Guérin (BCG), or platinum given as a radiationsensitizing agent will not be considered as a systemic line of treatment. Prior treatment with no more than
one prior immune checkpoint inhibitor is permitted and will not be considered as a line of systemic
chemotherapy. Patients enrolling after immune checkpoint inhibitor therapy must have demonstrated
disease progression while on that therapy or within 24 months after the last dose of that therapy.
 The patient has measurable disease or nonmeasurable but evaluable disease as defined by Response
Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
 The patient has an Eastern Cooperative Oncology Group performance status of 0 or 1.
 The patient is willing to provide blood, urine, and tissue samples for research purposes. Submission of
blood and urine specimens is mandatory for participation in this study, unless restricted per local
regulations. If prior archived tumor specimens are available, and unless restricted by local regulations,
submission of archived tumor tissue is mandatory. If an archived specimen is not available, submission of
a newly acquired biopsy is requested when biopsy is safe and feasible.
 The patient has adequate organ function.

Exclusion Criteria

Key Exclusion Criteria
 The patient has received more than one prior systemic chemotherapy regimen for metastatic disease
(except as noted in Inclusion Criteria). A treatment regimen must consist of minimum of 2 cycles to be
considered as a prior regimen.

The Estimated Number of Participants

  • Taiwan

    45 participants

  • Global

    524 participants

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