Study of Ramucirumab or IMC-18F1 With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01282463
First received: January 21, 2011
Last updated: July 21, 2014
Last verified: July 2014

January 21, 2011
July 21, 2014
April 2011
February 2015   (final data collection date for primary outcome measure)
Progression-free survival (PFS) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
Progression-free survival (PFS) [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01282463 on ClinicalTrials.gov Archive Site
  • Objective response rate (ORR) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Minimum concentration (Cmin) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Change in circulating levels of placental growth factor (PlGF) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Change in circulating levels of vascular endothelial growth factor-A (VEGF-A) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Change in circulating levels of vascular endothelial growth factor-B (VEGF-B) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Change in circulating levels of soluble vascular endothelial growth factor-1 (VEGFR-1) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Change in circulating levels of soluble vascular endothelial growth factor-2 (VEGFR-2) [ Time Frame: Approximately 40 months ] [ Designated as safety issue: No ]
  • Serum Anti-Ramucirumab Antibody Assessment [ Time Frame: Approximately 40 months ] [ Designated as safety issue: Yes ]
  • Serum Anti-18F1 Antibody Assessment [ Time Frame: Approximately 40 months ] [ Designated as safety issue: Yes ]
  • Objective response rate (ORR) [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events (AEs) [ Time Frame: 26 Months ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax) [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
  • Minimum concentration (Cmin) [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
  • Change in circulating levels of placental growth factor (PIGF) [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
  • Change in circulating levels of vascular endothelial growth factor-A (VEGF-A) [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
  • Change in circulating levels of vascular endothelial growth factor-B (VEGF-B) [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
  • Change in circulating levels of soluble vascular endothelial growth factor-1 (VEGFR-1) [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
  • Change in circulating levels of soluble vascular endothelial growth factor-2 (VEGFR-2) [ Time Frame: 26 Months ] [ Designated as safety issue: No ]
  • Serum Anti-Ramucirumab Antibody Assessment [ Time Frame: 26 Months ] [ Designated as safety issue: Yes ]
  • Serum Anti-18F1 Antibody Assessment [ Time Frame: 26 Months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study of Ramucirumab or IMC-18F1 With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma
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 IMC-18F1.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Carcinoma of Urinary Tract
  • Urethral Carcinoma
  • Carcinoma of Ureter
  • Carcinoma of Renal Pelvis
  • Drug: Docetaxel
    Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle
  • Biological: Ramucirumab DP
    Ramucirumab (DP): 10 mg/kg I.V. on day 1 of each 21-day cycle
    Other Names:
    • IMC-1121B
    • LY3009806
  • Biological: IMC-18F1
    12 mg/kg I.V. on day 1 and Day 8 of each 21-day cycle
    Other Names:
    • Icrucumab
    • LY3012212
  • Active Comparator: Docetaxel
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
    Intervention: Drug: Docetaxel
  • Experimental: Docetaxel + Ramucirumab DP
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
    Interventions:
    • Drug: Docetaxel
    • Biological: Ramucirumab DP
  • Experimental: Docetaxel + IMC-18F1
    Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
    Interventions:
    • Drug: Docetaxel
    • Biological: IMC-18F1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
138
August 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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 nonapproved 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 VEGF
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01282463
13943, CP20-0902, I4Y-IE-JCDC
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: 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) Eli Lilly and Company
Eli Lilly and Company
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP