Phase 2
Completed N=8
Study to Allow Access to Single Agent Panobinostat for Patients Who Are on s.a. Panobinostat Treatment in a Novartis-sponsored Study and Continue to Benefit From the Treatment as Judged by the Investigator
Hematologic Neoplasms
Source: ClinicalTrials.gov NCT01802879 ↗
Enrolled (actual)
8
Serious AEs
25.0%
Results posted
Dec 2019
Primary outcomePrimary: Overview of Adverse Events (Safety Set) — 6; 2; 2; 3 participants
Summary
The study allowed continued use of single agent panobinostat in patients who were on single agent panobinostat treatment in a Novartis-sponsored study which had met its endpoint and were benefiting from the treatment as judged by the investigator.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overview of Adverse Events (Safety Set) |
6; 2; 2; 3; 1; 0 | — |
| SECONDARY Percentage of Patients With Clinical Benefit as Assessed by the Investigator. |
7 | — |
Eligibility Criteria
Inclusion Criteria
- patient had been enrolled in a Novartis-sponsored, Oncology OGD&GMA study receiving s.a. oral panobinostat and had fulfilled all their requirements in the parent study
- patient had been benefiting from the treatment with s.a. oral panobinostat as determined by the guidelines of the parent protocol and according to the Investigator's clinical judgment
- patient had demonstated compliance
- patient had given written informed consent.
Exclusion Criteria
- patient had been permanently discontinued from s.a. oral panobinostat study treatment in the parent study due to unacceptable toxicity, withdrawal of consent, non-compliance to study procedures or any other reason (including progression of disease).
- patient had participated in a Novartis sponsored combincation trial where panobinostat was dispensed in combination with another study medication and was still receiving combination therapy
- patient was pregnant or nursing at the time of entry
- women of child-bearing potential and male patients with sexual partners of child-bearing potential who were unwilling to use highly effective methods of contraception during dosing and for a specified duration after stopping study treatment
Data sourced from ClinicalTrials.gov (NCT01802879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.