Combination of AUY922 With Trastuzumab in HER2+ Advanced Breast Cancer Patients Previously Treated With Trastuzumab
This study is ongoing, but not recruiting participants.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01271920
First received: November 3, 2010
Last updated: October 10, 2012
Last verified: October 2012
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Purpose
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unacceptable toxicity, death, or discontinuation from the study for any other reason, such as patient refusal, withdrawn consent, lost to follow-up or investigator decision.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced HER2-positive Breast Cancer |
Drug: AUY922 Drug: Trastuzumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase Ib/II, Multi-center, Open-label Study to Evaluate the Efficacy of AUY922 in Combination With Trastuzumab in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer, That Has Progressed After or During at Least One Trastuzumab-containing Regimen |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Trastuzumab
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD) of AUY922 in combination with Trastuzumab (phase lb) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Overall Response Rate as assessed by RECIST (phase ll) [ Time Frame: Every 8 weeks for the first 24 weeks and every 12 weeks thereafter ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess concentration of AUY922 and BJP762 in the blood at different time points (phase lb & ll) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Assess frequency, intensity and duration of Adverse Events as a Measure of Safety and Tolerability (phase lb & ll) [ Time Frame: average 6 months ] [ Designated as safety issue: Yes ]
- Progression Free Survival (PFS) at the RPTD dose (phase ll only) [ Time Frame: every 3 months until 24 months after the last patient has been enrolled ] [ Designated as safety issue: No ]
- Overall Survival (OS) at the RPTD dose [ Time Frame: every 3 months until 24 months after the last patient has been enrolled ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 44 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: AUY922 + Trastuzumab | Drug: AUY922 Drug: Trastuzumab |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female patients with confirmed HER-2 positive , non-operable locally advanced or metastatic breast cancer
- All patients must have received at least 1 but no more than 2 prior anti HER2 based regimens including at least 1 regimen containing Trastuzumab.
- All patients must have at least one measurable lesion as defined by RECIST criteria.
- All patients must have documented progressive disease following the last line of therapy before entering the study
- ECOG Performance status ≤ 1
Exclusion Criteria:
- Patients with known CNS metastasis which are: symptomatic or require treatment for symptom control and/or growing
- Prior treatment with any HSP90 or HDAC inhibitor
- Impaired cardiac function
- Acute or chronic liver or renal disease
- Patients who are currently receiving treatment with any medication which has a relative risk of prolonging the QTc interval or inducing Torsades de Pointes and cannot be switched or discontinued to an alternative drug prior to commencing AUY922
- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
- Patients who do not have either an archival tumor sample available or are unwilling to have a fresh tumor sample collected at baseline.
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271920
Locations
| United States, Arkansas | |
| Highlands Oncology Group Dept of Highlands Oncology Grp | |
| Fayetteville, Arkansas, United States, 72703 | |
| France | |
| Novartis Investigative Site | |
| Dijon Cedex, France, 21034 | |
| Novartis Investigative Site | |
| Saint-Herblain Cédex, France, 44805 | |
| Germany | |
| Novartis Investigative Site | |
| Essen, Germany, 45147 | |
| Novartis Investigative Site | |
| Tuebingen, Germany, 72076 | |
| Italy | |
| Novartis Investigative Site | |
| Prato, PO, Italy, 59100 | |
| Novartis Investigative Site | |
| Candiolo, TO, Italy, 10060 | |
| Singapore | |
| Novartis Investigative Site | |
| Singapore, Singapore, 119228 | |
| Spain | |
| Novartis Investigative Site | |
| Malaga, Andalucía, Spain, 29010 | |
| Novartis Investigative Site | |
| Santiago de Compostela, Galicia, Spain, 15706 | |
| Novartis Investigative Site | |
| Madrid, Spain, 28007 | |
| Sweden | |
| Novartis Investigative Site | |
| Stockholm, Sweden, SE-171 76 | |
| United Kingdom | |
| Novartis Investigative Site | |
| Birmingham, United Kingdom, B15 2TT | |
| Novartis Investigative Site | |
| Leicester, United Kingdom, LE1 5WW | |
| Novartis Investigative Site | |
| Manchester, United Kingdom, M20 2BX | |
| Novartis Investigative Site | |
| Oxford, United Kingdom, OX2 6HE | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Study Director: | Novartis Investigative Site | Novartis Investigative Site |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01271920 History of Changes |
| Other Study ID Numbers: | CAUY922A2109, 2009-015628-27 |
| Study First Received: | November 3, 2010 |
| Last Updated: | October 10, 2012 |
| Health Authority: | United States: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: Ministry of Health Netherlands: Dutch Health Care Inspectorate Singapore: Health Sciences Authority United Kingdom: Medicines and Healthcare Products Regulatory Agency Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency |
Keywords provided by Novartis:
|
Trastuzumab-refractory advanced HER2-positive breast cancer, Hsp90, 2nd or 3rd line treatment |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Trastuzumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013