Advanced Gastric CancerPhase 3GRANITE-1NCT00879333
Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC)
A Phase 3 study testing Everolimus in people with Advanced Gastric Cancer, run by Novartis Pharmaceuticals at 122 sites in 22 countries.
Trial summary
This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- Everolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 656 participants
- Where
- 122 sitesin 22 countries
- Study dates
- Jul 2009to Jan 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female patients > 18 years old
- Histologically or cytologically confirmed and documented gastric adenocarcinoma
- Documented progression after 1 or 2 prior chemotherapy treatments for advanced disease
- ECOG Performance Status of < 2
- Lab parameters within specifically defined intervals
- Able to provide written informed consent
Who cannot join
- Patients who have received > 2 prior systemic therapies for advanced disease
- Administration of another anticancer therapy within 3 weeks prior to randomization
- Chronic treatment with steroids or another immunosuppressive agent
- Major surgery within 2 weeks prior to randomization
- Patients with CNS metastases
- Any other severe and/or uncontrolled medical condition
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
122 sites in 22 countries.
122 sites in 22 countries
France15 sites
Novartis Investigative Site
Avignon, 84082
Novartis Investigative Site
Clermont-Ferrand, 63003
Novartis Investigative Site
Clichy, 92110
Novartis Investigative Site
Dijon, 21079
Novartis Investigative Site
Lyon, 69373
Novartis Investigative Site
Marseille, 13385
Novartis Investigative Site
Montpellier, 34298
Novartis Investigative Site
Nice, 06189
Novartis Investigative Site
Paris, 75015
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Poitiers, France, 86000
Novartis Investigative Site
Reims, 51092
Novartis Investigative Site
Rennes, 35062
Novartis Investigative Site
Toulouse, 31054
Novartis Investigative Site
Villejuif, 94805
China14 sites
Novartis Investigative Site
Beijing, 100036
Novartis Investigative Site
Beijing, 100039
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Guangzhou, Guangdong, 510515
Novartis Investigative Site
Guangzhou, 510060
Novartis Investigative Site
Hangzhou, Zhejiang, 310016
Novartis Investigative Site
Harbin, Heilongjiang, 150081
Novartis Investigative Site
Nanjing, Jiangsu, 210002
Novartis Investigative Site
Shanghai, 200003
Novartis Investigative Site
Shanghai, 200025
Novartis Investigative Site
Shanghai, 200032
Novartis Investigative Site
Shenyang, Liaoning
Novartis Investigative Site
Shijiazhuang, Hebei, 050011
Novartis Investigative Site
Suzhou, Jiangsu, 215006
Japan14 sites
Novartis Investigative Site
Chuo-ku, Tokyo, 104-0045
Novartis Investigative Site
Fukuoka, Fukuoka, 812-8582
Novartis Investigative Site
Kashiwa, Chiba, 277-8577
Novartis Investigative Site
Kitaadachi-gun, Saitama, 362-0806
Novartis Investigative Site
Koto, Tokyo, 135-8550
Novartis Investigative Site
Matsuyama, Ehime, 791-0280
Novartis Investigative Site
Mitaka, Tokyo, 181-8611
Novartis Investigative Site
Nagoya, Aichi-ken, 464-8681
Novartis Investigative Site
Sagamihara, Kanagawa, 252-0380
Novartis Investigative Site
Sapporo, Hokkaido, 060-8648
Novartis Investigative Site
Sayama, Osaka, 589-8511
Novartis Investigative Site
Sendai, Miyagi, 980-8574
Novartis Investigative Site
Takatsuki, Osaka, 569-8686
Novartis Investigative Site
Utsunomiya, Tochigi, 320-0834
Australia9 sites
Novartis Investigative Site
Box Hill, Victoria, 3128
Novartis Investigative Site
Canberra, Australian Capital Territory, 2605
Novartis Investigative Site
Clayton, Victoria, 3168
Novartis Investigative Site
Footscray, Victoria, 3011
Novartis Investigative Site
Heidelberg, Victoria, 3084
Novartis Investigative Site
Herston, Queensland, 4029
Novartis Investigative Site
Kurralta Park, South Australia, 5037
Novartis Investigative Site
North Adelaide, South Australia, 5006
Novartis Investigative Site
Prahran, Victoria, 3181
United States8 sites
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(4)
Dallas, Texas, 75390-8527
Henry Ford Hospital Dept. of Henry Ford Hospital
Detroit, Michigan, 48202-2689
Highlands Oncology Group DeptofHighlandsOncologyGrp(2)
Fayetteville, Arkansas, 72703
The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)
Fort Worth, Texas, 76104
University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology
Houston, Texas, 77030-4009
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
Loma Linda Oncology Medical Group Loma Linda
Redlands, California, 92374
University of Washington Cancer Care Seattle Cancer Alliance
Seattle, Washington, 98109-1023
Germany8 sites
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Bielefeld, 33604
Novartis Investigative Site
Frankfurt, 60488
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, 68305
Novartis Investigative Site
München, 81675
Novartis Investigative Site
Offenburg, 77652
Novartis Investigative Site
Trier, 54290
South Korea7 sites
Novartis Investigative Site
Jeonju, Jeollabuk-do, 561-712
Novartis Investigative Site
Seoul, Korea, 03722
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Korea, 06351
Novartis Investigative Site
Seoul, Korea, 110 744
Novartis Investigative Site
Seoul, 136-705
Novartis Investigative Site
Taegu, 700 - 721
United Kingdom7 sites
Novartis Investigative Site
East Yorkshire, HU16 5JQ
Novartis Investigative Site
London, SW3 6JJ
Novartis Investigative Site
London, WC1E 6HX
Novartis Investigative Site
Manchester, M20 4BX
Novartis Investigative Site
Northwood, Middlesex, HA6 2RN
Novartis Investigative Site
Sutton, Surrey, SM2 5PT
Novartis Investigative Site
Wolverhampton, WV10 0QP
Canada6 sites
Novartis Investigative Site
Montreal, Quebec, H3G 1A4
Novartis Investigative Site
North Vancouver, British Columbia, V7L 2L7
Novartis Investigative Site
Sherbrooke, Quebec, J1H 5N4
Novartis Investigative Site
Toronto, Ontario, M4N 3M5
Novartis Investigative Site
Toronto, Ontario, M5B 1W8
Novartis Investigative Site
Vancouver, British Columbia, V5Z 4E6
Italy5 sites
Novartis Investigative Site
Aviano, PN, 33081
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Frattamaggiore, 80020
Novartis Investigative Site
Modena, MO, 41100
Novartis Investigative Site
Rozzano, MI, 20089
Taiwan5 sites
Novartis Investigative Site
Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, 33305
Novartis Investigative Site
Liouying Township
Novartis Investigative Site
Niaosong Township, Taiwan, 83301
Novartis Investigative Site
Taipei, Taiwan, 10048
Novartis Investigative Site
Taipei
Belgium4 sites
Novartis Investigative Site
Charleroi, 6000
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Liège, 4000
Israel4 sites
Novartis Investigative Site
Jerusalem, 9112001
Novartis Investigative Site
Petah Tikva, 49100
Novartis Investigative Site
Ramat Gan, 5266202
Novartis Investigative Site
Rehovot, 76100
Argentina3 sites
Novartis Investigative Site
Buenos Aires, Buenos Aires, C1264AAA
Novartis Investigative Site
Córdoba, Córdoba Province, X5000IUG
Novartis Investigative Site
Rio Negro, Viedma, 8500
Thailand3 sites
Novartis Investigative Site
Bangkok, 10400
Novartis Investigative Site
Bangkok, 10700
Novartis Investigative Site
Songkhla, 90110
Mexico2 sites
Novartis Investigative Site
León, Guanajuato, 37000
Novartis Investigative Site
Mexico City, Mexico City, 14080
Peru2 sites
Novartis Investigative Site
San Borja, Lima region, 41
Novartis Investigative Site
San Isidro, Lima region, 27
Russia2 sites
Novartis Investigative Site
Moscow, 115478
Novartis Investigative Site
Saint Petersburg, 197758
About this study
Official title: A Randomized, Double-blind, Multi-center Phase III Study Comparing Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Gastric Cancer After Progression on 1 or 2 Prior Systemic Chemotherapy
This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.
- Conditions
- Advanced Gastric Cancer
- Being tested
- Everolimus, Everolimus placebo, Best Supportive Care (BSC)
- Keywords
- Gastric cancer,, advanced gastric cancer,, stomach neoplasm,, stomach disease,, adenocarcinoma of stomach,, GI neoplasm
- Medical subject headings
- Stomach Neoplasms, Stomach Diseases, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called RAD001
Everolimus was formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning.
Everolimus placeboDrug
Placebo was formulated to be indistinguishable from the everolimus tablets, also formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning.
Best Supportive Care (BSC)Drug
Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments.
| Study group | Role | What they receive |
|---|---|---|
| Everolimus + BSC | Experimental | All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments. Receives: Drug: Everolimus; Drug: Best Supportive Care (BSC) |
| Placebo + BSC | Placebo comparator | All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments. Receives: Drug: Everolimus placebo; Drug: Best Supportive Care (BSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
The primary objective of this study was to compare OS between everolimus + best supportive care (BSC) and placebo + BSC. OS, was defined as the time from date of randomization to the date of death due to any cause. If at the analysis cut-off date a patient was not known to have died, survival was censored at the date of the last contact. OS was analyzed using the Kaplan Meier estimates method.
Measured: 2.5 years
Secondary outcomes (6)
Progression Free Survival (PFS)
Progression free survival was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause, where progression was based on Investigator assessment of baseline and post-baseline scans according to RECIST. Progression free survival was censored if no PFS event was observed before the first to occur out of (i) the cut-off date, or (ii) the date when a further anticancer therapy was started. The censoring date was the date of the last adequate tumor assessment before either of these two events occurred. If a PFS event was observed after two or more missing or non-evaluable tumor assessments, then the date of progression was censored at the date of the last adequate tumor assessment; for a PFS event observed after a single missing or non-evaluable tumor assessment, the actual date of disease progression was used. Anslsis was done using Kaplan-Meier estimates method.
Measured: 2.5 years
Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores
The EORTC QLQ-C30 global health status/quality of life sub-scale (QL) was pre-specified as the primary domain of interest, followed by physical functioning (PF), social functioning (SF) and emotional functioning (EF).The EORTC QLQ-C30 questionnaire, along with a module specific for gastric cancer patients (EORTC QLQ-STO22), was used to evaluate PRO. The QLQ-C30 has five function scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and a global health status/quality of life scale. In addition, there are questions that assess specific symptoms. The QLQ-STO22 consists of 22 questions that make up five multi-item scales (dysphagia, pain, reflux, eating and anxiety) and four single-item scales (dry mouth, tasting, body image and hair loss).
Measured: 2.5 years
Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
The ECOG PS scale was used to classify patients according to their functional impairment, with scores ranging from 0 (fully active) to 5 (dead). An analysis of the time to definitive deterioration of the ECOG PS by one category of the score from baseline was performed. Definitive deterioration was defined as a definitive increase by one category from baseline in ECOG PS, with no later improvements observed during the course of the study. A single measure reporting an increase in ECOG PS is sufficient to consider it as a definitive worsening only if it was the last one available for the patient. Kaplan-Meier method was used to estimate the distribution function of time to definitive worsening.
Measured: 2.5 years
Overall Response Rate (ORR)
ORR was defined as the proportion of patients with measurable disease in whom best overall response (OR) was either complete response (CR) or partial response (PR) according to RECIST criteria.
Measured: 2.5 years
Everolimus Steady State Concentraions at Predose (Cmin) and Cmax at Week 5
Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose.
Measured: Week 5
Everolimus Steady State Concentraions at Predose (Cmin) and Cmax by Region Asia vs. Rest of the World (ROW) at Week 5
Cmin is the minimum (trough) steady-state drug concentration in the blood during multiple dosing and Cmax is the maximum (peak) blood drug concentration after dose administration. Cmax is estimated as the maximum of C1h and C2H. C1h is 1 hour post-dose blood concentration and C2h is 2 hour post-dose blood concentration. Only valid pre-dose (Cmin), C1h, and C2h everolimus samples were included in the analysis. Valid pre-dose samples were confirmed blood samples collected at steady-state, collected immediately prior to dosing on the same study day, and collected at approximately 24 ± 4 hours after the previous dose and with no vomiting within the first 4 hours following the last dose. Valid C1h and C2h samples were confirmed blood samples collected at steady-state and within ± 1 hour window and with no vomiting within the first 4 hours following the current and previous dose.
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 656 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879333
- Sponsor's protocol ID
- CRAD001R2301
- Other IDs
- 2008-006544-20, 2008
- Acronym
- GRANITE-1
- Status last verified
- Oct 2015
- First submitted
- 8 Apr 2009
- Last updated
- 3 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ohtsu A, Ajani JA, Bai YX, Bang YJ, Chung HC, Pan HM, Sahmoud T, Shen L, Yeh KH, Chin K, Muro K, Kim YH, Ferry D, Tebbutt NC, Al-Batran SE, Smith H, Costantini C, Rizvi S, Lebwohl D, Van Cutsem E. Everolimus for previously treated advanced gastric cancer: results of the randomized, double-blind, phase III GRANITE-1 study. J Clin Oncol. 2013 Nov 1;31(31):3935-43. doi: 10.1200/JCO.2012.48.3552. Epub 2013 Sep 16.
PubMed 24043745
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center Phase III Study Comparing Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Gastric Cancer After Progression on 1 or 2 Prior Systemic Chemotherapy
- ClinicalTrials.gov ID
- NCT00879333
- Acronym / sponsor ID
- GRANITE-1 / CRAD001R2301
- Conditions
- Advanced Gastric Cancer
- Keywords
- Gastric cancer,, advanced gastric cancer,, stomach neoplasm,, stomach disease,, adenocarcinoma of stomach,, GI neoplasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 656 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 Apr 2009 (estimated)
- Results
- Posted 6 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the safety and efficacy of RAD001 monotherapy in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus + BSC | Experimental | Drug: Everolimus, Drug: Best Supportive Care (BSC)All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments. |
| Placebo + BSC | Placebo comparator | Drug: Everolimus placebo, Drug: Best Supportive Care (BSC)All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients > 18 years old
- Histologically or cytologically confirmed and documented gastric adenocarcinoma
- Documented progression after 1 or 2 prior chemotherapy treatments for advanced disease
- ECOG Performance Status of < 2
- Lab parameters within specifically defined intervals
Key exclusion criteria (7 listed)
- Patients who have received > 2 prior systemic therapies for advanced disease
- Administration of another anticancer therapy within 3 weeks prior to randomization
- Chronic treatment with steroids or another immunosuppressive agent
- Major surgery within 2 weeks prior to randomization
- Patients with CNS metastases
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 |
|---|---|---|
| EverolimusAlso: RAD001Everolimus was formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning. | Drug | Everolimus + BSC |
| Everolimus placeboPlacebo was formulated to be indistinguishable from the everolimus tablets, also formulated as tablets of 5 mg strength. In both treatment arms, the study drug was given by continuous oral daily dosing of 10 mg (2 tablets x 5 mg) each morning. | Drug | Placebo + BSC |
| Best Supportive Care (BSC)Best supportive care is defined as care in accordance with the local practice of an individual institution or center, specifically excluding anti-cancer treatments. | Drug | Everolimus + BSC, Placebo + BSC |
Primary outcome
Overall Survival (OS)
Time frame: 2.5 years
The primary objective of this study was to compare OS between everolimus + best supportive care (BSC) and placebo + BSC. OS, was defined as the time from date of randomization to the date of death due to any cause. If at the analysis cut-off date a patient was not known to have died, survival was censored at the date of the last contact. OS was analyzed using the Kaplan Meier estimates method.
6 secondary outcomes
Progression Free Survival (PFS)
Time frame: 2.5 years
Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Scores
Time frame: 2.5 years
Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score
Time frame: 2.5 years
Overall Response Rate (ORR)
Time frame: 2.5 years
Everolimus Steady State Concentraions at Predose (Cmin) and Cmax at Week 5
Time frame: Week 5
Everolimus Steady State Concentraions at Predose (Cmin) and Cmax by Region Asia vs. Rest of the World (ROW) at Week 5
Time frame: Week 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24043745Ohtsu A, Ajani JA, Bai YX, Bang YJ, Chung HC, Pan HM, Sahmoud T, Shen L, Yeh KH, Chin K, Muro K, Kim YH, Ferry D, Tebbutt NC, Al-Batran SE, Smith H, Costantini C, Rizvi S, Lebwohl D, Van Cutsem E. Everolimus for previously treated advanced gastric cancer: results of the randomized, double-blind, phase III GRANITE-1 study. J Clin Oncol. 2013 Nov 1;31(31):3935-43. doi: 10.1200/JCO.2012.48.3552. Epub 2013 Sep 16.
- Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.Link provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
122 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Everolimus in people with Advanced Gastric Cancer, run by Novartis Pharmaceuticals at 122 sites in 22 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 6 inclusion and 7 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 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 122 sites in France, China, Japan, Australia, United States and 17 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (OS) (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00879333, which also lists 1 linked publication.
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 3 Nov 2015.