A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function

NCT00421044 | Completed Phase 1

• 1 other identifier: CEPO906A2121E1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

Brief Summary

Patients who participated in the core EPO2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone.

Conditions

Advanced Malignancies; Tumors

Keywords

EPO; Patupilone; Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability in patients with hepatic impairment will be assessed by adverse events (AEs), serious adverse events (SAEs) and out of range lab values

  at completion of the study

• To evaluate the preliminary anti-tumor activity which will be assessed by radiological scans every 6 weeks

  at completion of the study

Study Arms (3)

Arm A (Normal liver function)

EXPERIMENTAL

Drug: Patupilone/EPO906

Arm B (Mild liver dysfunction)

EXPERIMENTAL

Drug: Patupilone/EPO906

Arm C (Moderate liver dysfunction)

EXPERIMENTAL

Drug: Patupilone/EPO906

Interventions

Patupilone/EPO906 DRUG

Arm A (Normal liver function); Arm B (Mild liver dysfunction); Arm C (Moderate liver dysfunction)

Eligibility Criteria

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

You may qualify if:

• Completion of the core study is required for participation in the extension.
• years of age or older
• World Health Organization (WHO) Performance Status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work.
• Life expectancy of 3 months or more
• Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist

You may not qualify if:

• Severe and/or uncontrolled medical disease
• Known diagnosis of human immunodeficiency virus (HIV) infection
• Presence of any other active or suspected acute or chronic uncontrolled infection
• Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease
• History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (3)

University of California San Diego/Moores Cancer Center

La Jolla, California, 92093-0987, United States

Location

Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

epothilone B

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmeceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2007
• First Posted: January 11, 2007
• Study Start: May 1, 2006
• Primary Completion: February 1, 2008
• Last Updated: January 11, 2012

Record last verified: 2012-01

Locations

US (3)