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 août 2019 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
148
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Alberta
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Edmonton, Alberta, Canada, 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.
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British Columbia
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Kelowna, British Columbia, Canada, 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.
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Vancouver, British Columbia, Canada, 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.
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Ontario
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London, Ontario, Canada, 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.
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Ottawa, Ontario, Canada, 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.
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Toronto, Ontario, Canada, 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.
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California
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Los Angeles, California, États-Unis, 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.
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Sacramento, California, États-Unis, 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.
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San Francisco, California, États-Unis, 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.
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Colorado
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Aurora, Colorado, États-Unis, 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.
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Connecticut
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New Haven, Connecticut, États-Unis, 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.
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District of Columbia
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Washington, District of Columbia, États-Unis, 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.
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Florida
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Boca Raton, Florida, États-Unis, 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.
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Jacksonville, Florida, États-Unis, 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.
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Orlando, Florida, États-Unis, 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.
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Maryland
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Baltimore, Maryland, États-Unis, 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.
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Minnesota
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Rochester, Minnesota, États-Unis, 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.
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Nevada
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Las Vegas, Nevada, États-Unis, 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.
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New York
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Albany, New York, États-Unis, 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.
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New York, New York, États-Unis, 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.
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Oregon
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Springfield, Oregon, États-Unis, 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.
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South Carolina
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Charleston, South Carolina, États-Unis, 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.
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Tennessee
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Nashville, Tennessee, États-Unis, 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.
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Texas
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Bedford, Texas, États-Unis, 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.
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Dallas, Texas, États-Unis, 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.
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McAllen, Texas, États-Unis, 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.
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The Woodlands, Texas, États-Unis, 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.
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Webster, Texas, États-Unis, 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.
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Virginia
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Fairfax, Virginia, États-Unis, 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.
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Hampton, Virginia, États-Unis, 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.
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Washington
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Seattle, Washington, États-Unis, 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.
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Wenatchee, Washington, États-Unis, 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.
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Docetaxel
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
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Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle
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Expérimental: Docetaxel + Ramucirumab DP
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
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Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle
Ramucirumab (DP): 10 milligram/kilogram (mg/kg) intravenous (IV) on day 1 of each 21-day cycle
Autres noms:
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Expérimental: Docetaxel + Icrucumab
Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.
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Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle
12 mg/kg I.V. on day 1 and Day 8 of each 21-day cycle
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Progression-Free Survival (PFS)
Délai: Randomization to Measured PD or Death From Any Cause (Up To 40 Months)
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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.
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Randomization to Measured PD or Death From Any Cause (Up To 40 Months)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Percentage of Participants Achieving Objective Response Rate (ORR)
Délai: Randomization to Measured PD (Up to 40 Months)
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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.
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Randomization to Measured PD (Up to 40 Months)
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Duration of Response
Délai: First Criteria Met for CR or PR to Measured PD or Death From Any Cause (Up to 40 Months)
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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.
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First Criteria Met for CR or PR to Measured PD or Death From Any Cause (Up to 40 Months)
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Number of Participants With Adverse Events (AEs)
Délai: Up To 41.7 Months
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A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
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Up To 41.7 Months
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Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab
Délai: 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
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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
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PK: Minimum Concentration (Cmin) Ramucirumab
Délai: 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
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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
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PK: Cmax Icrucumab
Délai: Cycle 1:Predose,1 hr post-EOI, 48hr, 72hr Post-EOI; Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI
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Cycle 1:Predose,1 hr post-EOI, 48hr, 72hr Post-EOI; Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI
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PK: Cmin Icrucumab
Délai: Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI
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Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI
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Number of Participants With Serum Anti-Ramucirumab Antibody Assessment
Délai: 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
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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.
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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
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Number of Participants With Serum Anti-Icrucumab Antibody Assessment
Délai: Cycle 1 Day 1 and Day 8 Predose and 1hr Post Dose
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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.
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Cycle 1 Day 1 and Day 8 Predose and 1hr Post Dose
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Pharmacodynamics (PD): Change in Circulating Levels of Placental Growth Factor (PlGF)
Délai: 40 months
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40 months
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PD: Change in Circulating Levels of Vascular Endothelial Growth Factor-A (VEGF-A)
Délai: 40 months
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40 months
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PD: Change in Circulating Levels of Vascular Endothelial Growth Factor-B (VEGF-B)
Délai: 40 months
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40 months
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PD: Change in Circulating Levels of Soluble Vascular Endothelial Growth Factor-1 (VEGFR-1)
Délai: 40 months
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40 months
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PD: Change in Circulating Levels of Soluble Vascular Endothelial Growth Factor-2 (VEGFR-2)
Délai: 40 months
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40 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2011
Achèvement primaire (Réel)
1 février 2015
Achèvement de l'étude (Réel)
1 mars 2015
Dates d'inscription aux études
Première soumission
21 janvier 2011
Première soumission répondant aux critères de contrôle qualité
21 janvier 2011
Première publication (Estimation)
25 janvier 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 septembre 2019
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 août 2019
Dernière vérification
1 août 2019
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 13943
- CP20-0902 (Autre identifiant: ImClone Systems)
- I4Y-IE-JCDC (Autre identifiant: Eli Lilly and Company)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Oui
Description du régime IPD
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.
Délai de partage IPD
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.
Critères d'accès au partage IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Type d'informations de prise en charge du partage d'IPD
- Protocole d'étude
- Plan d'analyse statistique (PAS)
- Rapport d'étude clinique (CSR)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .