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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

26. August 2019 aktualisiert von: Eli Lilly and Company

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

148

Phase

Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Kanada
- Alberta
  - Edmonton, Alberta, Kanada, T6G 1Z2
    - 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.
- British Columbia
  - Kelowna, British Columbia, Kanada, V1Y5L3
    - 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, Kanada, V5Z 4E6
    - 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.
- Ontario
  - London, Ontario, Kanada, N6A 4L6
    - 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.
  - Ottawa, Ontario, Kanada, K1H 8L6
    - 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.
  - Toronto, Ontario, Kanada, 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.
Vereinigte Staaten
- California
  - Los Angeles, California, Vereinigte Staaten, 90033
    - 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.
  - Sacramento, California, Vereinigte Staaten, 95817
    - 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.
  - San Francisco, California, Vereinigte Staaten, 94115
    - 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.
- Colorado
  - Aurora, Colorado, Vereinigte Staaten, 80012
    - 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.
- Connecticut
  - New Haven, Connecticut, Vereinigte Staaten, 06520
    - 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.
- District of Columbia
  - Washington, District of Columbia, Vereinigte Staaten, 20037
    - 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.
- Florida
  - Boca Raton, Florida, Vereinigte Staaten, 33486
    - 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.
  - Jacksonville, Florida, Vereinigte Staaten, 32224
    - 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.
  - Orlando, Florida, Vereinigte Staaten, 32806
    - 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.
- Maryland
  - Baltimore, Maryland, Vereinigte Staaten, 21231
    - 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.
- Minnesota
  - Rochester, Minnesota, Vereinigte Staaten, 55902
    - 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.
- Nevada
  - Las Vegas, Nevada, Vereinigte Staaten, 89169
    - 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.
- New York
  - Albany, New York, Vereinigte Staaten, 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.
  - New York, New York, Vereinigte Staaten, 10032
    - 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.
- Oregon
  - Springfield, Oregon, Vereinigte Staaten, 97477
    - 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.
- South Carolina
  - Charleston, South Carolina, Vereinigte Staaten, 29425
    - 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.
- Tennessee
  - Nashville, Tennessee, Vereinigte Staaten, 37203
    - 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.
- Texas
  - Bedford, Texas, Vereinigte Staaten, 76022
    - 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.
  - Dallas, Texas, Vereinigte Staaten, 75246
    - 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.
  - McAllen, Texas, Vereinigte Staaten, 78503
    - 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.
  - The Woodlands, Texas, Vereinigte Staaten, 77380
    - 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.
  - Webster, Texas, Vereinigte Staaten, 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.
- Virginia
  - Fairfax, Virginia, Vereinigte Staaten, 22031
    - 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.
  - Hampton, Virginia, Vereinigte Staaten, 23666
    - 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.
- Washington
  - Seattle, Washington, Vereinigte Staaten, 98109
    - 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, Vereinigte Staaten, 98801
    - 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.

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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 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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Behandlung
Zuteilung: Zufällig
Interventionsmodell: Parallele Zuordnung
Maskierung: Keine (Offenes Etikett)

Anzahl der Arme

Waffen und Interventionen

Teilnehmergruppe / Arm	Intervention / Behandlung
Aktiver Komparator: Docetaxel Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.	Arzneimittel: Docetaxel Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle
Experimental: Docetaxel + Ramucirumab DP Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.	Arzneimittel: Docetaxel Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle Biologisch: Ramucirumab DP Ramucirumab (DP): 10 milligram/kilogram (mg/kg) intravenous (IV) on day 1 of each 21-day cycle Andere Namen: LY3009806 IMC-1121B
Experimental: Docetaxel + Icrucumab Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.	Arzneimittel: Docetaxel Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle Biologisch: Icrucumab 12 mg/kg I.V. on day 1 and Day 8 of each 21-day cycle Andere Namen: IMC-18F1 LY3012212

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Progression-Free Survival (PFS) Zeitfenster: 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.	Randomization to Measured PD or Death From Any Cause (Up To 40 Months)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Percentage of Participants Achieving Objective Response Rate (ORR) Zeitfenster: Randomization to Measured PD (Up to 40 Months)	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.	Randomization to Measured PD (Up to 40 Months)
Duration of Response Zeitfenster: First Criteria Met for CR or PR to Measured PD or Death From Any Cause (Up to 40 Months)	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.	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) Zeitfenster: Up To 41.7 Months	A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.	Up To 41.7 Months
Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab Zeitfenster: 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		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 Zeitfenster: 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		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 Zeitfenster: Cycle 1:Predose,1 hr post-EOI, 48hr, 72hr Post-EOI; Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI		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 Zeitfenster: Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI		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 Zeitfenster: 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 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.	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 Zeitfenster: Cycle 1 Day 1 and Day 8 Predose and 1hr Post Dose	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.	Cycle 1 Day 1 and Day 8 Predose and 1hr Post Dose
Pharmacodynamics (PD): Change in Circulating Levels of Placental Growth Factor (PlGF) Zeitfenster: 40 months		40 months
PD: Change in Circulating Levels of Vascular Endothelial Growth Factor-A (VEGF-A) Zeitfenster: 40 months		40 months
PD: Change in Circulating Levels of Vascular Endothelial Growth Factor-B (VEGF-B) Zeitfenster: 40 months		40 months
PD: Change in Circulating Levels of Soluble Vascular Endothelial Growth Factor-1 (VEGFR-1) Zeitfenster: 40 months		40 months
PD: Change in Circulating Levels of Soluble Vascular Endothelial Growth Factor-2 (VEGFR-2) Zeitfenster: 40 months		40 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Eli Lilly and Company

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

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.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. April 2011

Primärer Abschluss (Tatsächlich)

1. Februar 2015

Studienabschluss (Tatsächlich)

1. März 2015

Studienanmeldedaten

Zuerst eingereicht

21. Januar 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Januar 2011

Zuerst gepostet (Schätzen)

25. Januar 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. September 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. August 2019

Zuletzt verifiziert

1. August 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Karzinom, Nierenzelle

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

13943
CP20-0902 (Andere Kennung: ImClone Systems)
I4Y-IE-JCDC (Andere Kennung: Eli Lilly and Company)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD-Sharing-Zugriffskriterien

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Art der unterstützenden IPD-Freigabeinformationen

Studienprotokoll
Statistischer Analyseplan (SAP)
Klinischer Studienbericht (CSR)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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Vereinigte Staaten
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Noch keine Rekrutierung

Phase-I-Studie von Docetaxel und 177-Lutetium-PSMA-I&T in der Erstlinientherapie für Patienten mit metastasiertem kastrationsresistentem Prostatadenokarzinom (Lutécio)

Prostatakrebs (Adenokarzinom)

Brasilien
Akeso

Rekrutierung

Ivonescimab in Kombination mit Docetaxel bei fortgeschrittenen nicht-kleinzelligen Lungenkrebs (NSCLC)

Nicht-kleinzelligem Lungenkrebs

China
Nereus Pharmaceuticals, Inc.

Abgeschlossen

Phase-1/2-Studie mit dem gefäßschädigenden Wirkstoff NPI-2358 + Docetaxel bei Patienten mit fortgeschrittenem nicht-kleinzelligem Lungenkrebs

Krebs

Vereinigte Staaten, Australien, Indien, Chile, Brasilien, Argentinien
Zhuhai Beihai Biotech Co., Ltd

Abgeschlossen

Eine Bioäquivalenzstudie zur Docetaxel-Injektion bei Patienten mit soliden Tumoren

Solide Tumore | Bioäquivalenz | Docetaxel

Indien
Jiangsu HengRui Medicine Co., Ltd.
Shanghai Pulmonary Hospital, Shanghai, China

Abgeschlossen

Eine Studie zu Famitinib plus Docetaxel bei Patienten mit fortgeschrittenem nicht-Plattenepithelkarzinom und nicht-kleinzelligem Lungenkrebs (NSCLC)

Nicht-kleinzelliger Lungenkrebs (NSCLC)

China
Guangdong Provincial People's Hospital
Shanghai Henlius Biotech

Aktiv, nicht rekrutierend

Eine randomisierte kontrollierte Studie zu Serplulimab in Kombination mit Chemotherapie bei lokal fortgeschrittenem Magenadenokarzinom

Magenkrebs Stadium III

China
Sanofi

Abgeschlossen

Pulmonart: Docetaxel – Nicht-kleinzelliger Lungenkrebs (NSCLC)

Lungentumoren

Frankreich, Niederlande, Spanien, Truthahn, Belgien, Finnland, Italien, Vereinigtes Königreich
Fudan University

Noch keine Rekrutierung

Envafolimab plus Docetaxel in Kombination mit oder ohne Trilaciclib im Vergleich zu Docetaxel bei fortgeschrittenem NSCLC

Fortgeschrittener nicht-kleinzelliger Lungenkrebs

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

Studienübersicht

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Studienorte

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Studienplan

Wie ist die Studie aufgebaut?

Designdetails

Anzahl der Arme

Waffen und Interventionen

Teilnehmergruppe / Arm

Intervention / Behandlung

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme

Maßnahmenbeschreibung

Zeitfenster

Sekundäre Ergebnismessungen

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Maßnahmenbeschreibung

Zeitfenster

Mitarbeiter und Ermittler

Sponsor

Publikationen und hilfreiche Links

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Haupttermine studieren

Studienbeginn

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Studienanmeldedaten

Zuerst eingereicht

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

Zuerst gepostet (Schätzen)

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

Zuletzt verifiziert

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Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Beschreibung des IPD-Plans

IPD-Sharing-Zeitrahmen

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Klinische Studien zur Docetaxel

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