Urinary Bladder NeoplasmsPhase 3CILABNCT00625664
Larotaxel + Cisplatin Versus Gemcitabine + Cisplatin in First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
A Phase 3 study testing larotaxel (XRP9881), gemcitabine and cisplatin in people with Urinary Bladder Neoplasms, run by Sanofi at 160 sites in 19 countries.
Trial summary
This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- larotaxel (XRP9881), gemcitabine and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 160 sitesin 19 countries
- Study dates
- Feb 2008to Feb 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer
- ECOG Performance Status 0 or 1
- No prior palliative chemotherapy
Who cannot join
- (Neo)Adjuvant chemotherapy if < 6 months between end of (neo)adjuvant chemotherapy and relapse
- Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time of randomization
- Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose > 300 mg/m²
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
160 sites in 19 countries.
160 sites in 19 countries
United States52 sites
Sanofi-Aventis Investigational Site Number 840068
Anchorage, Alaska, 99508
Sanofi-Aventis Investigational Site Number 840060
Athens, Georgia, 30607
Sanofi-Aventis Investigational Site Number 840045
Baltimore, Maryland, 21201
Sanofi-Aventis Investigational Site Number 840035
Berkeley, California, 94704
Sanofi-Aventis Investigational Site Number 840020
Bethlehem, Pennsylvania, 18015
Sanofi-Aventis Investigational Site Number 840001
Boca Raton, Florida, 33486
Sanofi-Aventis Investigational Site Number 840030
Boise, Idaho, 83712
Sanofi-Aventis Investigational Site Number 840048
Boynton Beach, Florida, 33435
Sanofi-Aventis Investigational Site Number 840012
Burbank, California, 91505
Sanofi-Aventis Investigational Site Number 840041
Chapel Hill, North Carolina, 27599
Sanofi-Aventis Investigational Site Number 840052
Charleston, South Carolina, 29406
Sanofi-Aventis Investigational Site Number 840007
Charlotte, North Carolina, 28204
Sanofi-Aventis Investigational Site Number 840031
Denver, Colorado, 80262
Sanofi-Aventis Investigational Site Number 840006
Detroit, Michigan, 48201
Sanofi-Aventis Investigational Site Number 840065
Dunmore, Pennsylvania, 18512
Sanofi-Aventis Investigational Site Number 840039
Goshen, Indiana, 46526
Sanofi-Aventis Investigational Site Number 840009
Hackensack, New Jersey, 07601
Sanofi-Aventis Investigational Site Number 840008
Houston, Texas, 77014
Sanofi-Aventis Investigational Site Number 840018
Houston, Texas, 77030
Sanofi-Aventis Investigational Site Number 840049
Jacksonville, Florida, 32224
Sanofi-Aventis Investigational Site Number 840054
Kansas City, Kansas, 66160-7321
Sanofi-Aventis Investigational Site Number 840002
Knoxville, Tennessee, 37920
Sanofi-Aventis Investigational Site Number 840029
La Jolla, California, 92037
Sanofi-Aventis Investigational Site Number 840044
Lake Success, New York, 11042
Sanofi-Aventis Investigational Site Number 840061
Lakeland, Florida, 33805
Sanofi-Aventis Investigational Site Number 840026
Lansing, Michigan, 48510
Sanofi-Aventis Investigational Site Number 840046
Los Angeles, California, 90033
Sanofi-Aventis Investigational Site Number 840017
Lubbock, Texas, 79415
Sanofi-Aventis Investigational Site Number 840011
Madison, Wisconsin, 53792
Sanofi-Aventis Investigational Site Number 840025
Marshfield, Wisconsin, 54449
Sanofi-Aventis Investigational Site Number 840024
Maywood, Illinois, 60153
Sanofi-Aventis Investigational Site Number 840004
Metarie, Louisiana, 70006-290
Sanofi-Aventis Investigational Site Number 840038
Milwaukee, Wisconsin, 53226
Sanofi-Aventis Investigational Site Number 840013
New York, New York, 10021
Sanofi-Aventis Investigational Site Number 840050
New York, New York, 10032
Sanofi-Aventis Investigational Site Number 840057
Paducah, Kentucky, 42002
Sanofi-Aventis Investigational Site Number 840062
Peoria, Illinois, 61615
Sanofi-Aventis Investigational Site Number 840056
Rochester, New York, 14642
Sanofi-Aventis Investigational Site Number 840003
Sacramento, California, 95817
Sanofi-Aventis Investigational Site Number 840047
Saint Joseph, Michigan, 49805
Sanofi-Aventis Investigational Site Number 840016
San Antonio, Texas, 78229
Sanofi-Aventis Investigational Site Number 840005
San Bernardino, California, 92404
Sanofi-Aventis Investigational Site Number 840033
San Diego, California, 92103
Sanofi-Aventis Investigational Site Number 840036
Seattle, Washington, 98111
Sanofi-Aventis Investigational Site Number 840032
Stamford, Connecticut, 06902
Sanofi-Aventis Investigational Site Number 840019
Sylvania, Ohio, 43560
Sanofi-Aventis Investigational Site Number 840015
Syracuse, New York, 13210
Sanofi-Aventis Investigational Site Number 840064
Temple, Texas, 76508
Sanofi-Aventis Investigational Site Number 840010
The Woodlands, Texas, 77380
Sanofi-Aventis Investigational Site Number 840034
Washington D.C., District of Columbia, 20007
Sanofi-Aventis Investigational Site Number 840021
Washington D.C., District of Columbia, 20010
Sanofi-Aventis Investigational Site Number 840058
Woonsocket, Rhode Island, 02895
Spain12 sites
Sanofi-Aventis Investigational Site Number 724006
Badalona, 08916
Sanofi-Aventis Investigational Site Number 724001
Barcelona, 08003
Sanofi-Aventis Investigational Site Number 724004
Barcelona, 08025
Sanofi-Aventis Investigational Site Number 724008
Barcelona, 08035
Sanofi-Aventis Investigational Site Number 724002
Barcelona, 08036
Sanofi-Aventis Investigational Site Number 724003
Madrid, 28041
Sanofi-Aventis Investigational Site Number 724010
Oviedo, 33006
Sanofi-Aventis Investigational Site Number 724013
Palma de Mallorca, 07014
Sanofi-Aventis Investigational Site Number 724007
Palma de Mallorca, 07198
Sanofi-Aventis Investigational Site Number 724009
Pamplona, 31008
Sanofi-Aventis Investigational Site Number 724011
Santiago de Compostela, 15706
Sanofi-Aventis Investigational Site Number 724012
Zaragoza, 50009
Russia11 sites
Sanofi-Aventis Investigational Site Number 643009
Chelyabinsk, 454087
Sanofi-Aventis Investigational Site Number 643010
Kursk, 305035
Sanofi-Aventis Investigational Site Number 643006
Moscow, 105425
Sanofi-Aventis Investigational Site Number 643008
Moscow, 115478
Sanofi-Aventis Investigational Site Number 643004
Moscow, 117837
Sanofi-Aventis Investigational Site Number 643005
Moscow, 125284
Sanofi-Aventis Investigational Site Number 643001
Obninsk, 249036
Sanofi-Aventis Investigational Site Number 643002
Saint Petersburg, 191104
Sanofi-Aventis Investigational Site Number 643003
Saint Petersburg, 194354
Sanofi-Aventis Investigational Site Number 643007
Saint Petersburg, 197758
Sanofi-Aventis Investigational Site Number 643011
Saint Petersburg, 197758
France10 sites
Sanofi-Aventis Investigational Site Number 250006
Avignon, 84082
Sanofi-Aventis Investigational Site Number 250003
Bordeaux, 33076
Sanofi-Aventis Investigational Site Number 250005
Hyères, 83400
Sanofi-Aventis Investigational Site Number 250011
Le Mans, 72015
Sanofi-Aventis Investigational Site Number 250004
Lyon, 69008
Sanofi-Aventis Investigational Site Number 250012
Perpignan, 66012
Sanofi-Aventis Investigational Site Number 250007
Poitiers, 86021
Sanofi-Aventis Investigational Site Number 250008
Saint-Herblain, 44805
Sanofi-Aventis Investigational Site Number 250009
Strasbourg, 67091
Sanofi-Aventis Investigational Site Number 250001
Suresnes, 92151
Brazil7 sites
Sanofi-Aventis Investigational Site Number 076006
Barretos, 14784-400
Sanofi-Aventis Investigational Site Number 076004
Florianópolis, 88034-000
Sanofi-Aventis Investigational Site Number 076001
Porto Alegre, 90110-270
Sanofi-Aventis Investigational Site Number 076003
Porto Alegre, 90610-000
Sanofi-Aventis Investigational Site Number 076002
Rio de Janeiro, 20231-050
Sanofi-Aventis Investigational Site Number 076007
São Paulo, 01246-000
Sanofi-Aventis Investigational Site Number 076005
São Paulo, 04122 000
Italy7 sites
Sanofi-Aventis Investigational Site Number 380004
Bari, 70124
Sanofi-Aventis Investigational Site Number 380003
Lecce, 73100
Sanofi-Aventis Investigational Site Number 380005
Meldola, 47014
Sanofi-Aventis Investigational Site Number 380006
Pavia, 27100
Sanofi-Aventis Investigational Site Number 380002
Perugia, 06128
Sanofi-Aventis Investigational Site Number 380001
Roma, 00152
Sanofi-Aventis Investigational Site Number 380008
Viterbo, 01100
Netherlands7 sites
Sanofi-Aventis Investigational Site Number 528005
Amsterdam, 1091 HA
Sanofi-Aventis Investigational Site Number 528002
Arnhem, 6815 AD
Sanofi-Aventis Investigational Site Number 528006
Hoofddorp, 2134 TM
Sanofi-Aventis Investigational Site Number 528003
Maastricht, 6229 HX
Sanofi-Aventis Investigational Site Number 528004
Nijmegen, 6525 GA
Sanofi-Aventis Investigational Site Number 528001
Sittard-Geleen, 6162 BG
Sanofi-Aventis Investigational Site Number 528007
Zwolle, 8025 AB
South Africa7 sites
Sanofi-Aventis Investigational Site Number 710008
Bloemfontein, 9301
Sanofi-Aventis Investigational Site Number 710003
Cape Town, 7506
Sanofi-Aventis Investigational Site Number 710001
Cape Town, 7956
Sanofi-Aventis Investigational Site Number 710007
Durban, 4062
Sanofi-Aventis Investigational Site Number 710009
Durban, 4091
Sanofi-Aventis Investigational Site Number 710006
Port Elizabeth, 6001
Sanofi-Aventis Investigational Site Number 710005
Pretoria, 0181
Belgium6 sites
Sanofi-Aventis Investigational Site Number 056005
Aalst, 9300
Sanofi-Aventis Investigational Site Number 056001
Brussels, 1000
Sanofi-Aventis Investigational Site Number 056002
Brussels, 1200
Sanofi-Aventis Investigational Site Number 056004
Ottignies, 1340
Sanofi-Aventis Investigational Site Number 056003
Wilrijk, 2610
Sanofi-Aventis Investigational Site Number 056006
Yvoir, 5530
India6 sites
Sanofi-Aventis Investigational Site Number 356003
Bangalore, 560029
Sanofi-Aventis Investigational Site Number 356007
Kolkata, 700026
Sanofi-Aventis Investigational Site Number 356004
New Delhi, 110 029
Sanofi-Aventis Investigational Site Number 356001
New Delhi, 110001
Sanofi-Aventis Investigational Site Number 356002
Vellore, 632004
Sanofi-Aventis Investigational Site Number 356005
Visakhapatnam, 530002
Israel6 sites
Sanofi-Aventis Investigational Site Number 376005
Haifa, 31096
Sanofi-Aventis Investigational Site Number 376004
Kfar Saba, 44281
Sanofi-Aventis Investigational Site Number 376003
Petah Tikva, 49100
Sanofi-Aventis Investigational Site Number 376002
Tel Aviv, 64239
Sanofi-Aventis Investigational Site Number 376007
Tel HaShomer, 52621
Sanofi-Aventis Investigational Site Number 376001
Tzrifin, 70300
Argentina5 sites
Sanofi-Aventis Investigational Site Number 032002
Buenos Aires, C1120AAT
Sanofi-Aventis Investigational Site Number 032003
Ciudad de Buenos Aires, C1426BOR
Sanofi-Aventis Investigational Site Number 032004
Mendoza, 5500
Sanofi-Aventis Investigational Site Number 032005
Rosario, 2000
Sanofi-Aventis Investigational Site Number 032001
Santa Fe, 3000
Canada5 sites
Sanofi-Aventis Investigational Site Number 124007
Edmonton, T6G1Z2
Sanofi-Aventis Investigational Site Number 124001
London, N6A 4L6
Sanofi-Aventis Investigational Site Number 124006
Montreal, H2L 4M1
Sanofi-Aventis Investigational Site Number 124003
Québec, G1R 2J6
Sanofi-Aventis Investigational Site Number 124002
Weston, M9N 1N8
Turkey (Türkiye)5 sites
Sanofi-Aventis Investigational Site Number 792002
Ankara, 06100
Sanofi-Aventis Investigational Site Number 792003
Ankara, 065090
Sanofi-Aventis Investigational Site Number 792004
Ankara, 61080
Sanofi-Aventis Investigational Site Number 792006
Istanbul, 22030
Sanofi-Aventis Investigational Site Number 792001
Istanbul, 34093
Mexico4 sites
Sanofi-Aventis Investigational Site Number 484003
Aguascalientes, 20230
Sanofi-Aventis Investigational Site Number 484007
Chihuahua City, 31000
Sanofi-Aventis Investigational Site Number 484005
Chihuahua City, 31205
Sanofi-Aventis Investigational Site Number 484004
Monterrey, 64988
Poland4 sites
Sanofi-Aventis Investigational Site Number 616002
Poznan, 61-485
Sanofi-Aventis Investigational Site Number 616004
Rybnik, 44-200
Sanofi-Aventis Investigational Site Number 616001
Warsaw, 02-781
Sanofi-Aventis Investigational Site Number 616005
Wroclaw, 51-124
Australia3 sites
Sanofi-Aventis Investigational Site Number 036002
Adelaide, 5000
Sanofi-Aventis Investigational Site Number 036003
Bedford Park, 5042
Sanofi-Aventis Investigational Site Number 036004
St Leonards, 2065
Sweden2 sites
Sanofi-Aventis Investigational Site Number 752001
Umeå, 901 85
Sanofi-Aventis Investigational Site Number 752002
Uppsala, 751 85
About this study
Official title: Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- larotaxel (XRP9881), gemcitabine, cisplatin
- Keywords
- Cancer, Neoplasms, Bladder, Urothelial Tract
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
larotaxel (XRP9881)Drug
administered on day 1 as a 1-hour infusion
gemcitabineDrug
administered on day 1, 8 and 15 as a 30-minute infusion
cisplatinDrug
1 hour infusion administered on day 1, 30 minutes after the other treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: larotaxel (XRP9881); Drug: cisplatin |
| 2 | Active comparator | Not described Receives: Drug: gemcitabine; Drug: cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival defined as the time interval from the date of randomization to the date of death due to any cause
Measured: study period
Secondary outcomes (2)
Radiological tumor assessments (CT/MRI)
Measured: at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression
Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status
Measured: at screening and every cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625664
- Sponsor's protocol ID
- EFC6668
- Other IDs
- EUDRACT: 2007-001943-23
- Acronym
- CILAB
- Status last verified
- Apr 2016
- First submitted
- 19 Feb 2008
- Last updated
- 5 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer
- ClinicalTrials.gov ID
- NCT00625664
- Acronym / sponsor ID
- CILAB / EFC6668
- Conditions
- Urinary Bladder Neoplasms
- Keywords
- Cancer, Neoplasms, Bladder, Urothelial Tract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 28 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: larotaxel (XRP9881), Drug: cisplatin |
| 2 | Active comparator | Drug: gemcitabine, Drug: cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) with locally advanced (T4b) or metastatic urothelial tract or bladder cancer
- ECOG Performance Status 0 or 1
- No prior palliative chemotherapy
Key exclusion criteria (4 listed)
- (Neo)Adjuvant chemotherapy if < 6 months between end of (neo)adjuvant chemotherapy and relapse
- Less than 6 weeks elapsed from prior radiotherapy and less than 3 weeks from surgery to time of randomization
- Prior cisplatin as (neo)adjuvant chemotherapy with cumulative dose > 300 mg/m²
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| larotaxel (XRP9881)administered on day 1 as a 1-hour infusion | Drug | 1 |
| gemcitabineadministered on day 1, 8 and 15 as a 30-minute infusion | Drug | 2 |
| cisplatin1 hour infusion administered on day 1, 30 minutes after the other treatment | Drug | 1, 2 |
Primary outcome
Overall survival defined as the time interval from the date of randomization to the date of death due to any cause
Time frame: study period
2 secondary outcomes
Radiological tumor assessments (CT/MRI)
Time frame: at screening, every 8 weeks during treatment, at end of treatment, and in follow-up until documented disease progression
Adverse Events, laboratory assessments, vital signs, Physical Examinations, and ECOG Performance Status
Time frame: at screening and every cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
160 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing larotaxel (XRP9881), gemcitabine and cisplatin in people with Urinary Bladder Neoplasms, run by Sanofi at 160 sites in 19 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 160 sites in United States, Spain, Russia, France, Brazil and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival defined as the time interval from the date of randomization to the date of death due to any cause (time frame: study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.