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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015628-27 | EudraCT Number |
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The phase Ib part of the trial will assess the MTD of AUY922 in combination with Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+. The MTD is defined as the highest drug dosage not causing in the first cycle of treatment (28 days) medically unacceptable dose limiting toxicity (DLT).
The phase II part of the trial will assess any potential effect on efficacy of adding AUY922 to Trastuzumab in patients with Trastuzumab-refractory locally advanced or metastatic HER2+ breast cancer.
Both AUY922 and Trastuzumab will be administered as a weekly IV infusion. Treatment should be continued as long as the patient does not have disease progression and tolerates the treatment. The following reasons are examples of acceptable reasons for discontinuing the study; tumor progression (by RECIST, as assessed by the investigator), unacceptable toxicity, death, or discontinuation from the study for any other reason, such as patient refusal, withdrawn consent, lost to follow-up or investigator decision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AUY922 + Trastuzumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AUY922 | Drug |
| ||
| Trastuzumab |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD) of AUY922 in combination with Trastuzumab (phase lb) | 4 weeks | |
| Overall Response Rate as assessed by RECIST (phase ll) | Every 8 weeks for the first 24 weeks and every 12 weeks thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Assess concentration of AUY922 and BJP762 in the blood at different time points (phase lb & ll) | 4 weeks | |
| Assess frequency, intensity and duration of Adverse Events as a Measure of Safety and Tolerability (phase lb & ll) | average 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis Investigative Site | Novartis Investigative Site | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group Dept of Highlands Oncology Grp | Fayetteville | Arkansas | 72703 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27129177 | Result | Kong A, Rea D, Ahmed S, Beck JT, Lopez Lopez R, Biganzoli L, Armstrong AC, Aglietta M, Alba E, Campone M, Hsu Schmitz SF, Lefebvre C, Akimov M, Lee SC. Phase 1B/2 study of the HSP90 inhibitor AUY922 plus trastuzumab in metastatic HER2-positive breast cancer patients who have progressed on trastuzumab-based regimen. Oncotarget. 2016 Jun 21;7(25):37680-37692. doi: 10.18632/oncotarget.8974. |
| Label | URL |
|---|---|
| Results for CAUY922A2109 can be found on the Novartis Clinical Trials Results Website | View source |
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|
| Progression Free Survival (PFS) at the RPTD dose (phase ll only) | every 3 months until 24 months after the last patient has been enrolled |
| Overall Survival (OS) at the RPTD dose | every 3 months until 24 months after the last patient has been enrolled |
| Novartis Investigative Site |
| Dijon |
| 21034 |
| France |
| Novartis Investigative Site | Saint-Herblain Cédex | 44805 | France |
| Novartis Investigative Site | Essen | 45147 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Prato | PO | 59100 | Italy |
| Novartis Investigative Site | Candiolo | TO | 10060 | Italy |
| Novartis Investigative Site | Singapore | 119228 | Singapore |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Santiago de Compostela | Galicia | 15706 | Spain |
| Novartis Investigative Site | Madrid | 28009 | Spain |
| Novartis Investigative Site | Stockholm | SE-171 76 | Sweden |
| Novartis Investigative Site | Birmingham | B15 2TT | United Kingdom |
| Novartis Investigative Site | Leicester | LE1 5WW | United Kingdom |
| Novartis Investigative Site | Manchester | M20 2BX | United Kingdom |
| Novartis Investigative Site | Oxford | OX2 6HE | United Kingdom |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C528044 | 5-(2,4-dihydroxy-5-isopropylphenyl)-4-(4-morpholin-4-ylmethylphenyl)isoxazole-3-carboxylic acid ethylamide |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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