Carcinoma of Urinary TractPhase 2NCT01282463
Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma
A Phase 2 study testing Docetaxel, Ramucirumab DP and Icrucumab in people with Carcinoma of Urinary Tract and Urethral Carcinoma, run by Eli Lilly and Company at 32 sites in 2 countries.
Trial summary
This multicenter trial will enroll participants with metastatic transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis who have had disease progression on first-line platinum-based chemotherapy regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma of Urinary Tract, Urethral Carcinoma, Carcinoma of Ureter
- What is being tested?
- Docetaxel, Ramucirumab DP and Icrucumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Apr 2011to Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis
- Locally advanced or metastatic and unresectable transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis
- Had treatment with a platinum-containing regimen
- Disease progression within 12 months of after receiving the last dose of a platinum containing regimen in the neoadjuvant or adjuvant setting, and/or had disease progression while on a platinum-containing regimen or within 12 months after the last dose of therapy in the locally advanced or metastatic setting
- Has measurable or nonmeasurable disease
- Life expectancy of ≥ 3 months
Show all 14Show fewer
- Received no more than 2 prior systemic chemotherapy regimens in any setting
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Has adequate hematologic, coagulation, hepatic and renal function
- Does not have:
- cirrhosis at a level of Child-Pugh B (or worse)
- cirrhosis (any degree) and a history of hepatic encephalopathy or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
- If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method during and for 12 weeks after the treatment period
- If male, the patient is surgically sterile or compliant with a contraceptive regimen during and for 12 weeks after the treatment period
Who cannot join
- Received more than one prior systemic treatment regimen for metastatic disease
- Received prior systemic taxane therapy (except for prior paclitaxel therapy) for Transitional Cell Carcinoma of the bladder, urethra, ureter, or renal pelvis in any setting (neoadjuvant, adjuvant, metastatic). Prior intravesical taxane therapy is allowed
- Has received more than one prior anti-angiogenic agent for Transitional Cell Carcinoma of the bladder, urethra, ureter, or renal pelvis
- Has received radiation therapy within 4 weeks prior to randomization
- Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
- Has experienced a Grade ≥ 3 bleeding event (eg, via gastric ulcers, gastric varices, or gross hematuria) within 3 months prior to randomization
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- Has uncontrolled intercurrent illness including, but not limited to symptomatic anemia, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders
- Has experienced any arterial thrombotic or thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack or cerebrovascular accident, within 6 months prior to randomization
- Has known brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease
- Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy
- Has known human immunodeficiency virus infection or acquired immunodeficiency syndrome
- Has received a prior autologous or allogeneic organ or tissue transplantation
- Received chemotherapy within 21 days prior to randomization; and/or is currently enrolled in, or discontinued within 21 days prior to randomization from, a clinical trial involving an investigational product or unapproved use of a drug or device (other than the study drug[s] used in this study), or is concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study; and/or was treated with anti-angiogenic therapy within 28 days prior to randomization
- Has undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization
- Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
- Has an elective or planned major surgery to be performed during the course of the trial
- Is pregnant or lactating
- Has a concurrent active malignancy other than adequately treated non-melanomatous skin cancer, curatively treated cervical carcinoma in-situ, other noninvasive carcinoma or in-situ neoplasm, or prostate cancer with an undetectable prostate specific antigen (PSA) and no current treatment with hormone therapy
- Has an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention
- History of gastrointestinal perforation and/or fistula within 6 months prior to randomization
- Has active diverticulitis
- Known hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
- Known hypersensitivity to agents of similar biologic composition as ramucirumab DP, IMC-18F1, or other agents that specifically target vascular endothelial growth factor receptor (VEGF)
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States26 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Albany, New York, 12208
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Aurora, Colorado, 80012
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Baltimore, Maryland, 21231
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Bedford, Texas, 76022
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Boca Raton, Florida, 33486
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Charleston, South Carolina, 29425
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Dallas, Texas, 75246
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Fairfax, Virginia, 22031
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Hampton, Virginia, 23666
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Jacksonville, Florida, 32224
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Las Vegas, Nevada, 89169
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Los Angeles, California, 90033
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McAllen, Texas, 78503
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Nashville, Tennessee, 37203
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New Haven, Connecticut, 06520
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New York, New York, 10032
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Orlando, Florida, 32806
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Rochester, Minnesota, 55902
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Sacramento, California, 95817
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San Francisco, California, 94115
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Seattle, Washington, 98109
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Springfield, Oregon, 97477
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The Woodlands, Texas, 77380
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Washington D.C., District of Columbia, 20037
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Webster, Texas, 77598
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Wenatchee, Washington, 98801
Canada6 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Edmonton, Alberta, T6G 1Z2
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Kelowna, British Columbia, V1Y5L3
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London, Ontario, N6A 4L6
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Ottawa, Ontario, K1H 8L6
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Toronto, Ontario, M4X 1K9
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Docetaxel in Combination With Ramucirumab (IMC-1121B) Drug Product or IMC-18F1 or Without Investigational Therapy as Second-line Therapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Bladder, Urethra, Ureter, or Renal Pelvis Following Disease Progression on First-line Platinum-based Therapy
This multicenter trial will enroll participants with metastatic transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis who have had disease progression on first-line platinum-based chemotherapy regimens. Participants will be enrolled into 1 of 3 treatment arms: docetaxel; docetaxel and ramucirumab; or docetaxel and icrucumab.
- Conditions
- Carcinoma of Urinary Tract, Urethral Carcinoma, Carcinoma of Ureter, Carcinoma of Renal Pelvis
- Being tested
- Docetaxel, Ramucirumab DP, Icrucumab
- Keywords
- Carcinoma, Renal Cell
- Medical subject headings
- Urethral Neoplasms, Ureteral Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle
Ramucirumab DPBiological
Also called IMC-1121B, LY3009806
Ramucirumab (DP): 10 milligram/kilogram (mg/kg) intravenous (IV) on day 1 of each 21-day cycle
IcrucumabBiological
Also called IMC-18F1, LY3012212
12 mg/kg I.V. on day 1 and Day 8 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel | Active comparator | Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Receives: Drug: Docetaxel |
| Docetaxel + Ramucirumab DP | Experimental | Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Receives: Drug: Docetaxel; Biological: Ramucirumab DP |
| Docetaxel + Icrucumab | Experimental | Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. Receives: Drug: Docetaxel; Biological: Icrucumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.
Measured: Randomization to Measured PD or Death From Any Cause (Up To 40 Months)
Secondary outcomes (14)
Percentage of Participants Achieving Objective Response Rate (ORR)
Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)*100.
Measured: Randomization to Measured PD (Up to 40 Months)
Duration of Response
The duration of response was measured from the time measurement criteria were first met for a CR or PR (whichever was first recorded) until the first date of objectively documented progressive disease (taking as a reference for progressive disease the smallest measurement recorded since randomization) or the date of death, whichever occurred first. Data for participants who did not relapse or die were censored at the day of their last adequate tumor assessment. Duration of response was estimated by the Kaplan-Meier method.
Measured: First Criteria Met for CR or PR to Measured PD or Death From Any Cause (Up to 40 Months)
Number of Participants With Adverse Events (AEs)
A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Measured: Up To 41.7 Months
Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab
Measured: Cycle 1:Predose,1 hour(hr) post End of Infusion (EOI),48hr,72hr,168hr,336hr post-EOI;Cycle2:Predose,1hr post-EOI; Cycle3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI; Cycle4:Predose,1hr post-EOI;Cycle6 and every other cycle thereafter:Predose,1hr Post EOI
PK: Minimum Concentration (Cmin) Ramucirumab
Measured: Cycle 2:Predose,1hr post-EOI;Cycle3:Predose,1hr,48hr,72hr,168hr,336hr, post-EOI;Cycle4:Predose,1hr post-EOI;Cycle6:Predose,1hr Post EOI
PK: Cmax Icrucumab
Measured: Cycle 1:Predose,1 hr post-EOI, 48hr, 72hr Post-EOI; Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI
PK: Cmin Icrucumab
Measured: Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI
Number of Participants With Serum Anti-Ramucirumab Antibody Assessment
Number of participants with at least one positive titer treatment emergent antibody positive neutralizing antibody detecting. A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals.
Measured: Cycle 1:Predose,EOI,1hr,48hr,72hr,168hr,336 hr post-EOI:Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI;Cycle 4:Predose,1hr post-EOI;Cycle 6:Predose,1hr post-EOI
Number of Participants With Serum Anti-Icrucumab Antibody Assessment
A sample will be considered positive for anti-Icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-IMC-Icrucumab antibody level seen in healthy untreated individuals.
Measured: Cycle 1 Day 1 and Day 8 Predose and 1hr Post Dose
Pharmacodynamics (PD): Change in Circulating Levels of Placental Growth Factor (PlGF)
Measured: 40 months
PD: Change in Circulating Levels of Vascular Endothelial Growth Factor-A (VEGF-A)
Measured: 40 months
PD: Change in Circulating Levels of Vascular Endothelial Growth Factor-B (VEGF-B)
Measured: 40 months
PD: Change in Circulating Levels of Soluble Vascular Endothelial Growth Factor-1 (VEGFR-1)
Measured: 40 months
PD: Change in Circulating Levels of Soluble Vascular Endothelial Growth Factor-2 (VEGFR-2)
Measured: 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma of Urinary TractStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282463
- Sponsor's protocol ID
- 13943
- Other IDs
- CP20-0902, I4Y-IE-JCDC
- Status last verified
- Aug 2019
- First submitted
- 21 Jan 2011
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Petrylak DP, Tagawa ST, Kohli M, Eisen A, Canil C, Sridhar SS, Spira A, Yu EY, Burke JM, Shaffer D, Pan CX, Kim JJ, Aragon-Ching JB, Quinn DI, Vogelzang NJ, Tang S, Zhang H, Cavanaugh CT, Gao L, Kauh JS, Walgren RA, Chi KN. Docetaxel As Monotherapy or Combined With Ramucirumab or Icrucumab in Second-Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma: An Open-Label, Three-Arm, Randomized Controlled Phase II Trial. J Clin Oncol. 2016 May 1;34(13):1500-9. doi: 10.1200/JCO.2015.65.0218. Epub 2016 Feb 29.
PubMed 26926681
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Docetaxel in Combination With Ramucirumab (IMC-1121B) Drug Product or IMC-18F1 or Without Investigational Therapy as Second-line Therapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Bladder, Urethra, Ureter, or Renal Pelvis Following Disease Progression on First-line Platinum-based Therapy
- ClinicalTrials.gov ID
- NCT01282463
- Acronym / sponsor ID
- 13943
- Conditions
- Carcinoma of Urinary Tract, Urethral Carcinoma, Carcinoma of Ureter, Carcinoma of Renal Pelvis
- Keywords
- Carcinoma, Renal Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Posted 2 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter trial will enroll participants with metastatic transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis who have had disease progression on first-line platinum-based chemotherapy regimens. Participants will be enrolled into 1 of 3 treatment arms: docetaxel; docetaxel and ramucirumab; or docetaxel and icrucumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Docetaxel | Active comparator | Drug: DocetaxelCycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. |
| Docetaxel + Ramucirumab DP | Experimental | Drug: Docetaxel, Biological: Ramucirumab DPCycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. |
| Docetaxel + Icrucumab | Experimental | Drug: Docetaxel, Biological: IcrucumabCycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically confirmed transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis
- Locally advanced or metastatic and unresectable transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis
- Had treatment with a platinum-containing regimen
- Disease progression within 12 months of after receiving the last dose of a platinum containing regimen in the neoadjuvant or adjuvant setting, and/or had disease progression while on a platinum-containing regimen or within 12 months after the last dose of therapy in the locally advanced or metastatic setting
- Has measurable or nonmeasurable disease
Key exclusion criteria (23 listed)
- Received more than one prior systemic treatment regimen for metastatic disease
- Received prior systemic taxane therapy (except for prior paclitaxel therapy) for Transitional Cell Carcinoma of the bladder, urethra, ureter, or renal pelvis in any setting (neoadjuvant, adjuvant, metastatic). Prior intravesical taxane therapy is allowed
- Has received more than one prior anti-angiogenic agent for Transitional Cell Carcinoma of the bladder, urethra, ureter, or renal pelvis
- Has received radiation therapy within 4 weeks prior to randomization
- Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelDocetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle | Drug | Docetaxel, Docetaxel + Icrucumab, Docetaxel + Ramucirumab DP |
| Ramucirumab DPAlso: IMC-1121B, LY3009806Ramucirumab (DP): 10 milligram/kilogram (mg/kg) intravenous (IV) on day 1 of each 21-day cycle | Biological | Docetaxel + Ramucirumab DP |
| IcrucumabAlso: IMC-18F1, LY301221212 mg/kg I.V. on day 1 and Day 8 of each 21-day cycle | Biological | Docetaxel + Icrucumab |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Randomization to Measured PD or Death From Any Cause (Up To 40 Months)
PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.
14 secondary outcomes
Percentage of Participants Achieving Objective Response Rate (ORR)
Time frame: Randomization to Measured PD (Up to 40 Months)
Duration of Response
Time frame: First Criteria Met for CR or PR to Measured PD or Death From Any Cause (Up to 40 Months)
Number of Participants With Adverse Events (AEs)
Time frame: Up To 41.7 Months
Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab
Time frame: Cycle 1:Predose,1 hour(hr) post End of Infusion (EOI),48hr,72hr,168hr,336hr post-EOI;Cycle2:Predose,1hr post-EOI; Cycle3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI; Cycle4:Predose,1hr post-EOI;Cycle6 and every other cycle thereafter:Predose,1hr Post EOI
PK: Minimum Concentration (Cmin) Ramucirumab
Time frame: Cycle 2:Predose,1hr post-EOI;Cycle3:Predose,1hr,48hr,72hr,168hr,336hr, post-EOI;Cycle4:Predose,1hr post-EOI;Cycle6:Predose,1hr Post EOI
PK: Cmax Icrucumab
Time frame: Cycle 1:Predose,1 hr post-EOI, 48hr, 72hr Post-EOI; Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI
PK: Cmin Icrucumab
Time frame: Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI
Number of Participants With Serum Anti-Ramucirumab Antibody Assessment
Time frame: Cycle 1:Predose,EOI,1hr,48hr,72hr,168hr,336 hr post-EOI:Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI;Cycle 4:Predose,1hr post-EOI;Cycle 6:Predose,1hr post-EOI
Number of Participants With Serum Anti-Icrucumab Antibody Assessment
Time frame: Cycle 1 Day 1 and Day 8 Predose and 1hr Post Dose
Pharmacodynamics (PD): Change in Circulating Levels of Placental Growth Factor (PlGF)
Time frame: 40 months
PD: Change in Circulating Levels of Vascular Endothelial Growth Factor-A (VEGF-A)
Time frame: 40 months
PD: Change in Circulating Levels of Vascular Endothelial Growth Factor-B (VEGF-B)
Time frame: 40 months
PD: Change in Circulating Levels of Soluble Vascular Endothelial Growth Factor-1 (VEGFR-1)
Time frame: 40 months
PD: Change in Circulating Levels of Soluble Vascular Endothelial Growth Factor-2 (VEGFR-2)
Time frame: 40 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26926681Petrylak DP, Tagawa ST, Kohli M, Eisen A, Canil C, Sridhar SS, Spira A, Yu EY, Burke JM, Shaffer D, Pan CX, Kim JJ, Aragon-Ching JB, Quinn DI, Vogelzang NJ, Tang S, Zhang H, Cavanaugh CT, Gao L, Kauh JS, Walgren RA, Chi KN. Docetaxel As Monotherapy or Combined With Ramucirumab or Icrucumab in Second-Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma: An Open-Label, Three-Arm, Randomized Controlled Phase II Trial. J Clin Oncol. 2016 May 1;34(13):1500-9. doi: 10.1200/JCO.2015.65.0218. Epub 2016 Feb 29.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Ramucirumab DP and Icrucumab in people with Carcinoma of Urinary Tract and Urethral Carcinoma, run by Eli Lilly and Company at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Randomization to Measured PD or Death From Any Cause (Up To 40 Months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01282463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.