Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01007968 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics and Safety of Panobinostat in Patients With Advanced Solid Tumors and Various Degrees of Hepatic Function

A Phase 1 study of Advanced Solid Tumors, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target
6
Study locations

NCT01007968 is a Phase 1 study of Advanced Solid Tumors that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 25 participants, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (87% lower). The trial reports 6 study locations across 2 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01007968, a Phase 1 study of Advanced Solid Tumors, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target
6
Study locations

Study Summary

Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC inhibitor (pan-DACi) that has shown anti-tumor activity in pre-clinical models and patients with solid tumors and hematological malignancies. To date, the pharmacokinetics (PK) of panobinostat has been characterized in patients with solid tumors and hematological malignancies participating in several phase I/II clinical studies. Panobinostat PK does not appear to be different in patients with solid tumors and hematological malignancies. However, the effect of organ dysfunction on PK of panobinostat is yet to be elucidated. Kidney and liver are involved in the elimination and metabolism of panobinostat. The current study is designed to evaluate the impact of hepatic function status on panobinostat PK.

Conditions Studied

Advanced Solid Tumors

Interventions

  • DRUG LBH589

Study Locations (6)

Other

  • Novartis Investigative Site - Leiden
  • Novartis Investigative Site - Lund
  • Novartis Investigative Site - Stockholm
  • Novartis Investigative Site - Sankt Gallen
  • Novartis Investigative Site - Edinburgh

Utah

  • University of Utah / Huntsman Cancer Institute - Salt Lake City

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2010-03
Est. Completion 2012-11
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01007968

The ClinicalTrials.gov registry entry for NCT01007968 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (87% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which LBH589 is the first listed.

NCT01007968 reports 6 study locations spanning 2 distinct geographic areas - top geographies include Other, Utah.

Frequently Asked Questions

What is clinical trial NCT01007968 about?

NCT01007968 is a clinical study titled "Pharmacokinetics and Safety of Panobinostat in Patients With Advanced Solid Tumors and Various Degrees of Hepatic Function". Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC inhibitor (pan-DACi) that has shown anti-tumor activity in pre-clinical models and patients with solid tumors and...

What is the current status of trial NCT01007968?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2010-03. Estimated completion is 2012-11.

What conditions does trial NCT01007968 study?

This clinical trial studies the following conditions: Advanced Solid Tumors.

What interventions are being tested in trial NCT01007968?

The interventions under investigation include: LBH589 (DRUG).

Who is sponsoring clinical trial NCT01007968?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01007968 being conducted?

This trial has 6 study locations across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumors

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Advanced Solid Tumors

All registered trials for this condition

Utah

All trials with a study site in Utah

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.