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

Completed · Phase 2

Conditions studied: Hematologic Neoplasms

In brief

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.

Key facts

Study ID

NCT01802879

Run by

Novartis Pharmaceuticals

People needed

9

Starts

2013-06-24

Expected to finish

2018-11-19

Last updated by the study team

2019-12-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1) — Duarte, California, United States
• Georgia Regents University SC-2 — Augusta, Georgia, United States
• Dana Farber Cancer Institute Reg. Ped — Boston, Massachusetts, United States
• University of Utah / Huntsman Cancer Institute SC-2 — Salt Lake City, Utah, United States
• Novartis Investigative Site — Jerusalem, Israel
• Novartis Investigative Site — Leiden, Netherlands
• Novartis Investigative Site — Salamanca, Castille and León, Spain

Full record on ClinicalTrials.gov

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