A Phase Ib/IIa Trial of Panobinostat in Combination With Trastuzumab in Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed During or Following Therapy With Trastuzumab
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 56
- Locations
- 8
- Primary Endpoint
- Number of Participants With Dose Limiting Toxicities (DLTs)
Study Overview
Brief Summary
The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer
Detailed Description
This phase Ib/IIa study was prematurely terminated due to lack of efficacy noted in 55 patients with HER2-positive MBC who had progressed on or following a trastuzumab-based therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Panobinostat with trastuzumab
Panobinostat intravenously (i.v.) or orally was given in combination with trastuzumab.
Intervention: Panobinostat (Drug)
Panobinostat with trastuzumab
Panobinostat intravenously (i.v.) or orally was given in combination with trastuzumab.
Intervention: Trastuzumab (Drug)
Outcomes
Primary Outcomes
Number of Participants With Dose Limiting Toxicities (DLTs)
Time Frame: day 21
Safety data was reviewed to determine the DLTs. DLTs comprised adverse events (AEs) or abnormal laboratory values that occurred at any time and were assessed as clinically relevant and meeting any of the following criteria: considered to be related to the study treatment and unrelated to disease, disease progression, inter-current illness, or concomitant medications. Toxicities were assessed using the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE), version 3.0. Disease related symptoms were not considered a DLT.
Secondary Outcomes
- Number of Participants With Best Overall Response(day 21)