Advanced Gastric CancerPhase 2NCT01084330
Phase II Trial of AUY922 vs. Comparators in Advanced Gastric Cancer
A Phase 2 study testing AUY922, Docetaxel and Irinotecan in people with Advanced Gastric Cancer and Gastro-esophageal Junction Cancer, run by Novartis Pharmaceuticals at 36 sites in 14 countries.
Trial summary
A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs known to be effective against gastric cancer in second line therapy for patients who have failed one line of chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastric Cancer, Gastro-esophageal Junction Cancer
- What is being tested?
- AUY922, Docetaxel and Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 36 sitesin 14 countries
- Study dates
- Apr 2010to May 2012
- Phase
- Phase 2
- 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
- Radiologically confirmed advanced gastric cancer
- One previous line of chemotherapy
- Progressive disease
- One measurable lesion
- Blood tests within protocol ranges
- (WHO) Performance Status ≤ 1
- Able to sign informed consent
Who cannot join
- No symptomatic brain metastases
- No coumarin type anticoagulants
- No liver or kidney disease
- No impaired heart function
- No pregnant or lactating women
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
36 sites in 14 countries.
36 sites in 14 countries
United States7 sites
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU
Baltimore, Maryland, 21287-0013
Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology
Dallas, Texas, 75246
Horizon Oncology Center
Lafayette, Indiana, 47905
Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)
Lake Success, New York, 11042
USC/Kenneth Norris Comprehensive Cancer Center USC/Norris
Los Angeles, California, 90033
University of California at Los Angeles Dept. of UCLA (4)
Los Angeles, California, 90095
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
Tyler, Texas, 75702
Italy5 sites
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Modena, MO, 41100
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Pisa, PI, 56100
Novartis Investigative Site
Roma, RM, 00168
Taiwan4 sites
Novartis Investigative Site
Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, 33305
Novartis Investigative Site
Tainan, 704
Novartis Investigative Site
Taipei, 10048
Novartis Investigative Site
Taipei
United Kingdom4 sites
Novartis Investigative Site
Glasgow, G12 0YN
Novartis Investigative Site
Leicester, LE7 5WW
Novartis Investigative Site
Surrey, England, GU2 7XX
Novartis Investigative Site
Sutton, Surrey, SM2 5PT
France3 sites
Novartis Investigative Site
Bordeaux, 33075
Novartis Investigative Site
Lyon, 69373
Novartis Investigative Site
Toulouse, 31059
South Korea3 sites
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Suwon, Gyeonggi-do, 442-723
Novartis Investigative Site
Suwon, Gyeonggi-do, 443-380
Germany2 sites
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Ulm, 89081
Russia2 sites
Novartis Investigative Site
Moscow, 115478
Novartis Investigative Site
Moscow, 129128
About this study
Official title: A Randomized, Open-label, Multi-center Phase II Study to Compare AUY922 With Docetaxel or Irinotecan in Adult Patients With Advanced Gastric Cancer, Who Have Progressed After One Line of Chemotherapy
A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs known to be effective against gastric cancer in second line therapy for patients who have failed one line of chemotherapy.
- Being tested
- AUY922, Docetaxel, Irinotecan
- Keywords
- gastric cancer, metastatic gastric cancer, advanced gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AUY922Drug
70mg/m2
DocetaxelDrug
Docetaxel 75mg/m2
IrinotecanDrug
Iriniotecan 350mg/m2
| Study group | Role | What they receive |
|---|---|---|
| AUY922 | Experimental | Not described Receives: Drug: AUY922 |
| Docetaxel or Irinotecan | Active comparator | Not described Receives: Drug: Docetaxel; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Measured: 21 day cycle: treatment until death, lost to follow up or withdrawal
Secondary outcomes (3)
Estimate of the Overall Survival Treatment Effect to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.
Measured: 21 day cycle: treatment until death, lost to follow up or withdrawal
Objective Response Rate to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.
Measured: 21 day cycle: treatment until death, lost to follow up or withdrawal
Evaluate Safety by measuring cardiac safety, recording Adverse Events (AEs) and tracking the tolerability of AUY922
Measured: 21 day cycle: treatment until death, lost to follow up or withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 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
- NCT01084330
- Sponsor's protocol ID
- CAUY922A2202
- Other IDs
- 2009-015407-47, 2009
- Status last verified
- Aug 2020
- First submitted
- 5 Mar 2010
- Last updated
- 10 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multi-center Phase II Study to Compare AUY922 With Docetaxel or Irinotecan in Adult Patients With Advanced Gastric Cancer, Who Have Progressed After One Line of Chemotherapy
- ClinicalTrials.gov ID
- NCT01084330
- Acronym / sponsor ID
- CAUY922A2202
- Keywords
- gastric cancer, metastatic gastric cancer, advanced gastric cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Mar 2010 (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.
A clinical trial to determine the effectiveness and safety of AUY922 compared to other drugs known to be effective against gastric cancer in second line therapy for patients who have failed one line of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AUY922 | Experimental | Drug: AUY922 |
| Docetaxel or Irinotecan | Active comparator | Drug: Docetaxel, Drug: Irinotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Radiologically confirmed advanced gastric cancer
- One previous line of chemotherapy
- Progressive disease
- One measurable lesion
- Blood tests within protocol ranges
Key exclusion criteria (6 listed)
- No symptomatic brain metastases
- No coumarin type anticoagulants
- No liver or kidney disease
- No impaired heart function
- No pregnant or lactating women
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 |
|---|---|---|
| AUY92270mg/m2 | Drug | AUY922 |
| DocetaxelDocetaxel 75mg/m2 | Drug | Docetaxel or Irinotecan |
| IrinotecanIriniotecan 350mg/m2 | Drug | Docetaxel or Irinotecan |
Primary outcome
Progression Free Survival
Time frame: 21 day cycle: treatment until death, lost to follow up or withdrawal
3 secondary outcomes
Estimate of the Overall Survival Treatment Effect to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.
Time frame: 21 day cycle: treatment until death, lost to follow up or withdrawal
Objective Response Rate to see if there is a difference in treatment effect in patients who receive AUY922 versus patients who receive comparator medications.
Time frame: 21 day cycle: treatment until death, lost to follow up or withdrawal
Evaluate Safety by measuring cardiac safety, recording Adverse Events (AEs) and tracking the tolerability of AUY922
Time frame: 21 day cycle: treatment until death, lost to follow up or withdrawal
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 10 Dec 2020.
- ESMO AbstractLink provided by the sponsor.
- Results for CAUY922A2202 can be found on the Novartis Clinical Trial Results websiteLink 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
36 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AUY922, Docetaxel and Irinotecan in people with Advanced Gastric Cancer and Gastro-esophageal Junction Cancer, run by Novartis Pharmaceuticals at 36 sites in 14 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 7 inclusion and 6 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 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Italy, Taiwan, United Kingdom, France and 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Progression Free Survival (time frame: 21 day cycle: treatment until death, lost to follow up or withdrawal). 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 10 Dec 2020.