Advanced Gastric CancerPhase 2NCT01402401
Phase II of AUY922 in Second-line Gastric Cancer in Combination With Trastuzumab in HER2 Positive Patients
A Phase 2 study testing AUY922 and Trastuzumab in people with Advanced Gastric Cancer, run by Novartis Pharmaceuticals at 15 sites in 8 countries.
Trial summary
This study will assess the safety and efficacy of AUY922, when administered, in combination with trastuzumab in adult patients with HER2+ advanced gastric cancer, who have received trastuzumab plus chemotherapy in the first line. 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?
- AUY922 and Trastuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 15 sitesin 8 countries
- Study dates
- Nov 2011to Jun 2013
- 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
- Patients eligible for inclusion in this study have to meet all of the following criteria:
- Written informed consent obtained prior to any screening procedures
- Patients with documented cytological or histological confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma and proven HER2 positive.
- Patients with progressive disease (radiological confirmation required according to RECIST) after first line of trastuzumab in combination with chemotherapy for advanced gastric cancer.
- Age ≥ 18 years or age of consent in country of residence and able to sign Informed Consent
- ECOG performance status of 0-1 at study entry
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- HER2-overexpressing positive gastric tumor by IHC3+ or IHC2+ with positive in situ hybridization
- Measurable disease according to RECIST (Irradiated lesions can not be considered measurable unless they have clearly progressed since radiotherapy).
- Negative serum pregnancy test. The serum pregnancy test must be obtained prior to any drug administration (≤ 72 hours prior to dosing) in all pre-menopausal women and for women < 2 years after the onset of menopause.
- Patients must have the following laboratory values:
- Hematologic
- Absolute Neutrophil Count (ANC) ≥1.5x109/L,
- Hemoglobin (Hgb) ≥ 9 g/dL,
- Platelets (plt) ≥100x109/L
- Biochemistry:
- Serum total bilirubin ≤ 1.5 x ULN
- Serum albumin > 2.5 g/dl
- Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 ml/min.
- AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 x ULN if liver metastases are present
Who cannot join
- Patients eligible for this study must not meet any of the following criteria:
- Evidence of spinal cord compression or current evidence of CNS metastases. CT/MRI of the brain is mandatory (within 3 weeks before study start) in case of clinical suspicion or evidence of brain metastases
- Patient who are < 4 weeks since last chemotherapy or treatment with another systemic anti-cancer agent. Patients must have recovered (CTC ≤ 1) from acute toxicities of any previous therapy (with the exception of alopecia).
- Patients may have received prior radiotherapy for management of local disease providing that disease progression has been documented, all toxicities have resolved (CTC ≤ 1) (with the exception of alopecia), and the last fraction of radiotherapy was completed at least 4 weeks prior to the study.
- Prior treatment with an agent that acts via HER2/c-erbB2 targeting other than 1st line trastuzumab, include (but are not limited to) lapatinib and pertuzumab.
- Treatment with therapeutic doses of coumarin-type anticoagulants. (Maximum daily dose of 2 mg, for line patency permitted)
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- Patients with malignant ascites that require invasive treatment
- Patients with acute or chronic renal disease; and active and chronic liver disease requiring intervention. Other concurrent severe and/or uncontrolled medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol.
- Major surgery ≤ 2 weeks prior to enrollment or who have not recovered from such therapy
- Impaired cardiac function
- Concurrent malignancies or invasive cancers diagnosed within the past 5 years, except for adequately treated basal cell cancer of the skin or in situ cancer of the cervix
- Patients receiving chronic or high dose corticosteroids therapy (Inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed)
- Patients unwilling or unable to comply with the protocol
- Patients known to be HIV positive. Testing is not required in the absence of clinical signs and symptoms suggesting HIV infection.
- Known hypersensitivity to any of the study drugs or their excipients
- Participation in another clinical study within 30 days before first study treatment
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
- Fertile women of childbearing potential (WOCBP) not using adequate contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).
Trial locations and contacts
15 sites in 8 countries.
15 sites in 8 countries
United States3 sites
University of Texas/MD Anderson Cancer Center UT SC
Houston, Texas, 77030-4009
Clinical Research Alliance
Lake Success, New York, 11042
University of California at Los Angeles UCLA LeConte Location
Los Angeles, California, 90095
France3 sites
Novartis Investigative Site
Bordeaux, 33075
Novartis Investigative Site
Nice, 06189
Novartis Investigative Site
Reims, 51092
Germany2 sites
Novartis Investigative Site
Heilbronn, 74078
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, 68305
Japan2 sites
Novartis Investigative Site
Kashiwa, Chiba, 277-8577
Novartis Investigative Site
Sapporo, Hokkaido, 060-8648
South Korea2 sites
Novartis Investigative Site
Seoul, Korea, 110 744
Novartis Investigative Site
Seoul, Korea, 135-710
About this study
Official title: An Open-label, Single-arm, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AUY922 in Combination With Trastuzumab Standard Therapy as Second-line Treatment in Patients With HER2-positive Advanced Gastric Cancer
This study will assess the safety and efficacy of AUY922, when administered, in combination with trastuzumab in adult patients with HER2+ advanced gastric cancer, who have received trastuzumab plus chemotherapy in the first line.
- Conditions
- Advanced Gastric Cancer
- Being tested
- AUY922, Trastuzumab
- Keywords
- HER2+,, Gastric Cancer,, HSP90,, 2nd-line,, Trastuzumab
- 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
TrastuzumabDrug
| Study group | Role | What they receive |
|---|---|---|
| AUY922 + Trastuzumab | Experimental | Not described Receives: Drug: AUY922; Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of AUY922 in combination with trastuzumab as assessed by RECIST
Measured: every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionJun 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 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
- NCT01402401
- Sponsor's protocol ID
- CAUY922A2205
- Other IDs
- 2011-002570-23
- Status last verified
- Aug 2020
- First submitted
- 24 Jul 2011
- 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
- An Open-label, Single-arm, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AUY922 in Combination With Trastuzumab Standard Therapy as Second-line Treatment in Patients With HER2-positive Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT01402401
- Acronym / sponsor ID
- CAUY922A2205
- Conditions
- Advanced Gastric Cancer
- Keywords
- HER2+,, Gastric Cancer,, HSP90,, 2nd-line,, Trastuzumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Jul 2011 (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 study will assess the safety and efficacy of AUY922, when administered, in combination with trastuzumab in adult patients with HER2+ advanced gastric cancer, who have received trastuzumab plus chemotherapy in the first line.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AUY922 + Trastuzumab | Experimental | Drug: AUY922, Drug: Trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Written informed consent obtained prior to any screening procedures
- Patients with documented cytological or histological confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma and proven HER2 positive.
- Patients with progressive disease (radiological confirmation required according to RECIST) after first line of trastuzumab in combination with chemotherapy for advanced gastric cancer.
- Age ≥ 18 years or age of consent in country of residence and able to sign Informed Consent
- ECOG performance status of 0-1 at study entry
Key exclusion criteria (18 listed)
- Evidence of spinal cord compression or current evidence of CNS metastases. CT/MRI of the brain is mandatory (within 3 weeks before study start) in case of clinical suspicion or evidence of brain metastases
- Patient who are < 4 weeks since last chemotherapy or treatment with another systemic anti-cancer agent. Patients must have recovered (CTC ≤ 1) from acute toxicities of any previous therapy (with the exception of alopecia).
- Patients may have received prior radiotherapy for management of local disease providing that disease progression has been documented, all toxicities have resolved (CTC ≤ 1) (with the exception of alopecia), and the last fraction of radiotherapy was completed at least 4 weeks prior to the study.
- Prior treatment with an agent that acts via HER2/c-erbB2 targeting other than 1st line trastuzumab, include (but are not limited to) lapatinib and pertuzumab.
- Treatment with therapeutic doses of coumarin-type anticoagulants. (Maximum daily dose of 2 mg, for line patency permitted)
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 |
|---|---|---|
| AUY922 | Drug | AUY922 + Trastuzumab |
| Trastuzumab | Drug | AUY922 + Trastuzumab |
Primary outcome
efficacy of AUY922 in combination with trastuzumab as assessed by RECIST
Time frame: every 6 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Results for CAUY922A2205 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
15 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AUY922 and Trastuzumab in people with Advanced Gastric Cancer, run by Novartis Pharmaceuticals at 15 sites in 8 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 19 inclusion and 18 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: stopped early, 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 15 sites in United States, France, Germany, Japan, South Korea and 3 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 was stopped early. Results are not available in the source record.
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?
efficacy of AUY922 in combination with trastuzumab as assessed by RECIST (time frame: every 6 weeks). 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.