Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hematologic Neoplasms
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 fr...
Detailed Description
This was a multi-center open label study to provide continued use of single agent oral panobinostat to patients treated in a Novartis-sponsored study (parent study) which had met its endpoint and were...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 24 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01802879
Start Date
June 24 2013
End Date
November 19 2018
Last Update
December 6 2019
Active Locations (7)
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1
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)
Duarte, California, United States, 91010 3000
2
Georgia Regents University SC-2
Augusta, Georgia, United States, 30912
3
Dana Farber Cancer Institute Reg. Ped
Boston, Massachusetts, United States, 02215
4
University of Utah / Huntsman Cancer Institute SC-2
Salt Lake City, Utah, United States, 84103