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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced HER2-positive Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) and/or recommended phase two dose (RPTD) of AUY922 in combination with Trastuzumab (phase lb)

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CAUY922A2109

NCT ID:

NCT01271920

Start Date:

September 2010

Completion Date:

May 2014

Related Keywords:

  • Advanced HER2-positive Breast Cancer
  • Trastuzumab-refractory
  • advanced HER2-positive breast cancer,
  • Hsp90,
  • 2nd or 3rd line treatment
  • Breast Neoplasms

Name

Location

Highlands Oncology Group Dept of Highlands Oncology Grp Fayetteville, Arkansas  72703