Efficacy and Safety Study of Panobinostat in Participants With Metastatic Hormone Refractory Prostate Cancer

NCT00667862 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CLBH589C22082007-004995-37
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 5

Brief Summary

This Phase II single dose study was designed to characterize the safety, tolerability, and efficacy of intravenous (i.v.) panobinostat as a single-agent treatment in participants with hormone refractory prostate cancer.

Conditions

Prostate Cancer

Keywords

Prostate; Cancer; Adenocarcinoma; Prostate-Specific Antigen; metastatic; male; HRPC; DACi

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Progression-Free Survival (PFS) Rate at 24 Weeks

  The PFS rate was defined as the percentage of participants that were alive without documented disease progression at the end of 24 weeks from first study treatment. Disease Progression as per response evaluation criteria in solid tumors (RECIST) criteria: Measurable lesions: If target lesion was lymph node then it had to be at least 2 centimeter (cm) at baseline to assess change in size. Bone lesions: (non-target lesions) appearance of greater than or equal to (\>=) 2 unequivocal new lesions confirmed on a second scan at least 6 weeks later.

  24 weeks

Secondary Outcomes (7)

• Percentage of Participants With Tumor Response Rate

  Every 12 weeks up to approximately 2.7 years

• Percentage of Participants With Duration of Stable Disease (SD) Per RECIST

  Every 12 weeks up to approximately 2.7 years

• Percentage of Participants With Prostate Specific Antigen (PSA) Response Rate at 24 Weeks

  24 weeks

• Percentage of Participants With PSA Progression Rate at 24 Weeks

  24 weeks

• Median Progression-free Survival (PFS)

  After every cycle up to approximately 2.7 years

Study Arms (1)

Panobinostat

EXPERIMENTAL

Participants with metastatic hormone refractory prostate cancer received 20 milligrams per meter square (mg/m\^2) of panobinostat intravenously (i.v.) on Days 1 and 8 of a 21-day cycle. Treatment continued until disease progression as per investigator, intolerable toxicity, start of new cancer therapy, death, or withdrawal of consent.

Drug: Panobinostat

Interventions

Panobinostat DRUG

Also known as: LBH589

Panobinostat

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only male participants are eligible as it is a prostate cancer study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of adenocarcinoma of the prostate
• Participants with metastatic hormone refractory prostate cancer
• Participants that have had at least one, but not more than two prior cytotoxic treatments for prostate cancer
• Evidence of disease progression by at least one of the following:
• two or more lesions on bone scan
• progressive measurable disease
• two documented increases in prostate-specific antigen (PSA)
• Willing to use contraception throughout the study and for 12 weeks after study completion

You may not qualify if:

• History or clinical signs of central nervous system (CNS) disease
• History of other cancers not curatively treated with no evidence of disease for more than 5 years
• Prior radiotherapy within 3 weeks of starting study treatment
• Prior radiopharmaceuticals (strontium, samarium)
• Impaired cardiac function
• Heart disease
• Liver or renal disease with impaired function

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (5)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Wisconsin

Madison, Wisconsin, 53706-1481, United States

Location

Related Publications (1)

• Rathkopf DE, Picus J, Hussain A, Ellard S, Chi KN, Nydam T, Allen-Freda E, Mishra KK, Porro MG, Scher HI, Wilding G. A phase 2 study of intravenous panobinostat in patients with castration-resistant prostate cancer. Cancer Chemother Pharmacol. 2013 Sep;72(3):537-44. doi: 10.1007/s00280-013-2224-8. Epub 2013 Jul 3.

  PMID: 23820963 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Adenocarcinoma; Neoplasm Metastasis

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

862-778-8300

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: April 18, 2008
• First Posted: April 28, 2008
• Study Start: March 18, 2008
• Primary Completion: November 5, 2010
• Study Completion: November 5, 2010
• Last Updated: June 21, 2021
• Results First Posted: June 21, 2021

Record last verified: 2021-05

Locations

US (5)