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

NCT01802879 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CLBH589B2402B2012-005252-41
• Study Type: interventional
• Target: 9
• Locations: 4 countries
• Sites: 7

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 from the treatment as judged by the investigator.

Conditions

Hematologic Neoplasms

Keywords

Hematologic Neoplasms, LBH589,; Panobinostat,

Outcome Measures

Primary Outcomes (1)

• Overview of Adverse Events (Safety Set)

  Adverse events were collected from baseline up to 30 days post treatment at scheduled visits. Severity of adverse events was assessed according to the current version of Common Terminology Criteria for Adverse Events (CTCAE). If CTCAE grading did not exist for an adverse event, the severity of mild, moderate, severe, and life-threatening, corresponding to Grades 1 - 4, was used

  Baseline up to approximately 60 months

Secondary Outcomes (1)

• Percentage of Patients With Clinical Benefit as Assessed by the Investigator.

  baseline up to approximate 5 years

Study Arms (1)

Panobinostat - 10 to 40 mg/day TIW QoW

EXPERIMENTAL

10 to 40mg/day TIW QoW (3 times/week every other week) as per parent protocol design

Drug: Panobinostat

Interventions

Panobinostat DRUG

Panobinostat was provided as 5, 10 and 20 mg hard gelatin capsules to be taken orally. Patients started on dose from parent protocol and dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.

Panobinostat - 10 to 40 mg/day TIW QoW

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (7)

City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)

Duarte, California, 91010 3000, United States

Location

Georgia Regents University SC-2

Augusta, Georgia, 30912, United States

Location

Dana Farber Cancer Institute Reg. Ped

Boston, Massachusetts, 02215, United States

Location

University of Utah / Huntsman Cancer Institute SC-2

Salt Lake City, Utah, 84103, United States

Location

Novartis Investigative Site

Jerusalem, 91120, Israel

Location

Novartis Investigative Site

Leiden, 2300 RC, Netherlands

Location

Novartis Investigative Site

Salamanca, Castille and León, 37007, Spain

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

888-669-6682

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 4, 2013
• Study Start: June 24, 2013
• Primary Completion: November 19, 2018
• Study Completion: November 19, 2018
• Last Updated: December 6, 2019
• Results First Posted: December 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

IL (1); US (4); ES (1); NL (1)