Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer

February 13, 2017 updated by: Novartis Pharmaceuticals

A Randomized, Open-label, Multi-center Phase II Study to Compare Bevacizumab Plus RAD001 Versus Interferon Alfa-2a Plus Bevacizumab for the First-line Treatment of Patients With Metastatic Clear Cell Carcinoma of the Kidney

To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
365

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Novartis Investigative Site
      • Bruxelles, Belgium, 1070
        • Novartis Investigative Site
      • Charleroi, Belgium, 6000
        • Novartis Investigative Site
      • Kortrijk, Belgium, 8500
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
      • Liege, Belgium, 4000
        • Novartis Investigative Site
  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20230-130
        • Novartis Investigative Site
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Novartis Investigative Site
      • Porto Alegre, RS, Brazil, 90560-030
        • Novartis Investigative Site
    • SP
      • Ribeirao Preto, SP, Brazil, 14015-130
        • Novartis Investigative Site
      • Santo Andre, SP, Brazil, 09060-650
        • Novartis Investigative Site
      • São Paulo, SP, Brazil, 01246-000
        • Novartis Investigative Site
  • Czech Republic
      • Olomouc, Czech Republic, 775 20
        • Novartis Investigative Site
      • Prague, Czech Republic, 140 00
        • Novartis Investigative Site
  • Egypt
      • Cairo, Egypt
        • Novartis Investigative Site
  • France
      • Avignon, France, 84000
        • Novartis Investigative Site
      • Bordeaux Cedex, France, 33075
        • Novartis Investigative Site
      • Caen Cedex, France, 14021
        • Novartis Investigative Site
      • La Roche sur Yon Cedex, France, 85925
        • Novartis Investigative Site
      • Montellier cedex 5, France, 34298
        • Novartis Investigative Site
      • Nantes cedex 2, France, 44202
        • Novartis Investigative Site
      • Reims, France, 51100
        • Novartis Investigative Site
      • Rouen Cedex, France, 76031
        • Novartis Investigative Site
      • Strasbourg Cedex, France, 67010
        • Novartis Investigative Site
      • Suresnes, France, 92150
        • Novartis Investigative Site
      • Toulouse Cedex 9, France, 31059
        • Novartis Investigative Site
    • Cedex
      • Strasbourg, Cedex, France, 67091
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10117
        • Novartis Investigative Site
      • Berlin, Germany, 13055
        • Novartis Investigative Site
      • Dessau, Germany, 06846
        • Novartis Investigative Site
      • Essen, Germany, 45122
        • Novartis Investigative Site
      • Frankfurt, Germany, 60590
        • Novartis Investigative Site
      • Frankfurt, Germany, 60488
        • Novartis Investigative Site
      • Göttingen, Germany, 37075
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Heidelberg, Germany, 69115
        • Novartis Investigative Site
      • Leipzig, Germany, 04109
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • Tübingen, Germany, 72076
        • Novartis Investigative Site
  • Hong Kong
      • Shatin, New Territories, Hong Kong
        • Novartis Investigative Site
      • Tuen Mun, Hong Kong
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1086
        • Novartis Investigative Site
      • Budapest, Hungary, 1122
        • Novartis Investigative Site
  • Italy
      • Napoli, Italy, 80131
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italy, 25123
        • Novartis Investigative Site
    • CR
      • Cremona, CR, Italy, 26100
        • Novartis Investigative Site
    • CZ
      • Catanzaro, CZ, Italy, 88100
        • Novartis Investigative Site
    • FI
      • Firenze, FI, Italy, 50134
        • Novartis Investigative Site
    • MI
      • Milano, MI, Italy, 20133
        • Novartis Investigative Site
    • MO
      • Modena, MO, Italy, 41100
        • Novartis Investigative Site
    • PG
      • Perugia, PG, Italy, 06129
        • Novartis Investigative Site
    • PN
      • Aviano, PN, Italy, 33081
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00152
        • Novartis Investigative Site
      • Roma, RM, Italy, 00128
        • Novartis Investigative Site
    • TN
      • Trento, TN, Italy, 38100
        • Novartis Investigative Site
    • VR
      • Negrar, VR, Italy, 37024
        • Novartis Investigative Site
  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-703
        • Novartis Investigative Site
      • Seoul, Korea, Republic of, 136-705
        • Novartis Investigative Site
      • Taegu, Korea, Republic of, 700 -721
        • Novartis Investigative Site
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 03722
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, Korea, Republic of, 06351
        • Novartis Investigative Site
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Novartis Investigative Site
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Novartis Investigative Site
      • Moscow, Russian Federation, 125284
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 191104
        • Novartis Investigative Site
      • Saint-Petersburg, Russian Federation, 197758
        • Novartis Investigative Site
    • Russia
      • Obninsk, Russia, Russian Federation, 249036
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 258500
        • Novartis Investigative Site
  • South Africa
      • Johannesburg, South Africa, 2196
        • Novartis Investigative Site
      • Pretoria, South Africa, 0001
        • Novartis Investigative Site
      • Pretoria, South Africa, 0044
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Novartis Investigative Site
      • Santander, Spain, 39008
        • Novartis Investigative Site
      • Zaragoza, Spain, 50009
        • Novartis Investigative Site
    • Andalucía
      • Jaen, Andalucía, Spain, 23007
        • Novartis Investigative Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Novartis Investigative Site
      • Chur, Switzerland, 7000
        • Novartis Investigative Site
  • Taiwan
      • Lin-Kou, Taiwan, 33305
        • Novartis Investigative Site
      • Taichung, Taiwan, 40705
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 114
        • Novartis Investigative Site
    • Taiwan, ROC
      • Taipei, Taiwan, ROC, Taiwan, 112
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Novartis Investigative Site
      • Songkla, Thailand, 90110
        • Novartis Investigative Site
  • Turkey
      • Adana, Turkey, 01330
        • Novartis Investigative Site
      • Altunizade, Turkey, 34662
        • Novartis Investigative Site
      • Ankara, Turkey, 06100
        • Novartis Investigative Site
      • Antalya, Turkey, 07070
        • Novartis Investigative Site
      • Balcova / Izmir, Turkey, 35340
        • Novartis Investigative Site
      • Bursa, Turkey, 16059
        • Novartis Investigative Site
      • Mecidiyekoy/Istanbul, Turkey, 34394
        • Novartis Investigative Site
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Novartis Investigative Site
      • Southampton, United Kingdom, SO16 6YD
        • Novartis Investigative Site
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Novartis Investigative Site
  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Highlands Oncology Group Dept of Highlands Oncology Grp
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(3)
      • Los Angeles, California, United States, 90053
        • USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
      • Los Angeles, California, United States, 90095
        • University of California at Los Angeles Dept. of Hem/Oncology
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute Dept. of Nevada Cancer (3)
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States
        • St. Luke's Hospital and Health Network St. Luke's Cancer Network
    • Texas
      • Irving, Texas, United States, 75038
        • Las Colinas Hematology Oncology Grapevine
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Cancer Care Alliance Dept. of SCCA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with metastatic renal cell carcinoma
  2. Patients with at least one measurable lesion
  3. Patients with progressive metastatic renal cell carcinoma
  4. Patients who had a prior partial or complete nephrectomy
  5. Patients with a Karnofsky Performance Status ≥70%.
  6. Adequate bone marrow function
  7. Adequate liver function
  8. Adequate renal function
  9. Adequate coagulation profile

Exclusion Criteria:

  1. 4 weeks post-major surgery
  2. Patients who had radiation therapy within 28 days prior to start of study
  3. Patients in need for major surgical procedure during the course of the study.
  4. Patients with a serious non-healing wound, ulcer, or bone fracture.
  5. Patients with a history of seizure(s) not controlled with standard medical therapy.
  6. Patients who have received prior systemic treatment for their metastatic RCC.
  7. Patients who received prior therapy with VEGF pathway inhibitor
  8. Patients who have previously received systemic mTOR inhibitors
  9. Patients with a known hypersensitivity RAD001 (everolimus) or other rapamycins or to its excipients.
  10. Patients with history or current central nervous system (CNS) metastases or spinal cord compression.
  11. Patients with a history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
  12. Patients with proteinuria at screening.
  13. Patients with inadequately controlled hypertension
  14. Patients receiving ongoing or with recent need for full therapeutic dose of oral or parenteral anticoagulants or chronic daily treatment with aspirin
  15. Patients receiving chronic systemic treatment with corticosteroids or another immunosuppressive agent.
  16. Patients with a known history of HIV
  17. Patients with hypersensitivity to interferon alfa-2a or any component of the product.
  18. Patients with an active, bleeding diathesis or coagulopathy or recurrent thromboembolism
  19. Patients who have any severe and/or uncontrolled medical conditions or other conditions
  20. Left Ventricular Ejection Fraction < lower limit of institutional normal assessed by ECHO or MUGA
  21. Patients who have a history of another primary malignancy ≤ 3 years
  22. Female patients who are pregnant or breast feeding
  23. Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to study treatment start.
  24. Patients unwilling to or unable to comply with the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: bevacizumab, RAD001 (everolimus)
Participants received oral everolimus 10 mg qd plus intravenous bevacizumab 10mg/kg every 2 weeks
Drug: RAD001(everolimus)
10 mg qd
Other Names:
  • Afinitor
Drug: bevacizumab
10 mg/kg every 2 weeks
ACTIVE_COMPARATOR: bevacizumab, interferon alfa-2a (IFN)
Participants received subcutaneous IFN dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3 of treatment and subsequently (if tolerated), 3 times per week plus intravenous bevacizumab 10 mg/kg every 2 weeks
Drug: bevacizumab
10 mg/kg every 2 weeks
Drug: interferon alfa-2a
dose escalated from 3 MIU (million international unit) during week 1, 6 MIU during week 2, and 9 MIU during week 3

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) of Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Time Frame: Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.
Tumor response and disease progression were assessed using response evaluation criteria in solid tumors (RECIST), version 1.0. All target and non-target lesions identified at baseline were assessed using the same method, CT scan with contrast or MRI with contrast, throughout the trial. All scans were reviewed by independent, central radiology. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.
Time from randomization to the date of radiological progressive disease as per independent central review, death from any cause, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cutoff date.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) Treatment Effect in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Time Frame: Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012)
Overall survival (OS) was defined as the time of randomization to the date of death due to any cause.
Time from randomization to the date of death from any cause, reported between date of first participant randomized and up to 2 years after the last participant randomized (data cutoff: 30Aug2012)
Best Overall Response in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Time Frame: Time from first participant randomized until 31Dec2011, cutoff date.
Overall response is defined as the number of participants having achieved confirmed Complete Response (CR) + Partial Response (PR). Confirmed CR = at least two determinations of CR at least 4 weeks apart before progression. Confirmed PR = at least two determinations of PR or better at least 4 weeks apart before progression. CR required a disappearance of all target and non-target lesions. PR required at least a 30% decrease in the sum of the longest diameters of all target lesions, taking as a reference the baseline sum of the longest diameters. Disease progression was defined as: 1) a 20% increase in the sum of the longest diameter of all target lesions, taking as reference the smallest sum of the longest diameters of all target lesions recorded at or after baseline or 2) the appearance of a new lesions or 3) the unequivocal progression of non-target lesions overall.
Time from first participant randomized until 31Dec2011, cutoff date.
Response Duration Differences in Participants Who Received RAD001 Plus Bevacizumab Versus Participants Who Received IFN Plus Bevacizumab
Time Frame: Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date.
The duration of response, applied only to participants with best overall response at CR or PR, is defined as the number of days between the date of first documented response (CR or PR) and the date of the event: radiological progression as per central review or death due to underlying cancer, whichever occurs first. If no event, participant is censored at the last adequate assessment.
Time from first documented response date of radiological progressive disease as per independent central review, death due to underlying cancer, or last tumor assessment, reported between date of first participant randomized until 31Dec2011, cut-off date.
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events and Deaths
Time Frame: From the first participant randomized until the last patient discontinued the study treatment + 28 days
Participants were monitored for adverse events, serious adverse events and deaths throughout the study. Participants were assessed continuously at each 28-day cycle.
From the first participant randomized until the last patient discontinued the study treatment + 28 days
Time to Definitive Deterioration of the Functional Assessment of Cancer Therapy Kidney Symptom Index, Disease Related Symptoms (FKSI-DRS) Risk Score by at Least 2 Score Units
Time Frame: Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011
The analysis of this outcome measure was based on the FKSI-DRS scale which is a validated disease-related symptom index containing 9 items that measure symptoms predominantly related to kidney cancer. Each item is scored on a 5-point scale (0 = not at all; 4 = very much). If at least 5 of the 9 questions have been answered, the FKSI-DRS total score is calculated by subtracting nine times the mean of the scores of the answered items from 36. Participants with less than 5 out of the 9 questions answered will have a missing FKSI-DRS total score. The FKSI-DRS total score ranges from 0 (most severe symptoms) to 36 (no symptoms). Definitive deterioration is defined as a decrease by at least 2 units compared to baseline, with no later increase above this threshold observed during the study. A single measure reporting a decrease of at least 2 units was considered definitive only if it is the last one available for the participant.
Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first patient randomized until 31Dec2011
Time to Definitive Deterioration of the Global Health Status and the Physical Functioning (PF) Subscale Scores of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) by at Least 10%
Time Frame: Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011
The EORTC QLQ-C30 contains 30 items. These include five functional scales (physical, role, emotional, social and cognitive functioning), three symptom scales (fatigue, pain, nausea, and vomiting), a global health status/QoL scale, and six single items (dyspnea, diarrhea, constipation, anorexia, insomnia and financial impact). The PF subscale consists of 5 questions each scored from 1 (not at all) to 4 (very much). The score for the PF subscale and global health status range from 0 to 100, with a higher score representing a high level of functioning/high quality of life. Definitive deterioration by at least 10% is defined as a decrease in score by at least 10% compared to baseline, with no later increase above this threshold observed during the course of the study. A single measure reporting a decrease of at least 10% is considered definitive only if it is the last one available for the participant.
Time from randomization to the date of definitive deterioration (defined as no later increase above the threshold observed during the study), or date of last assessment, reported between date of first participant randomized until 31Dec2011
Duration of Exposure of RAD001 in Participants Randomized to the Treatment Combination of RAD001 and Bevacizumab
Time Frame: From the date of the first participant treated until the last patient discontinued the study treatment + 28 days
This outcome measure was assessed continuously.
From the date of the first participant treated until the last patient discontinued the study treatment + 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Pharma AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2008

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRAD001L2201
  • 2008-000077-38 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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