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An Open-label, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Malignancies, Tumors

Thank you

Trial Information

An Open-label, Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function


Inclusion Criteria:



- Completion of the core study is required for participation in the extension.

- 18 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

Exclusion Criteria:

- 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

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

at completion of the study

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmeceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CEPO906A2121E1

NCT ID:

NCT00421044

Start Date:

May 2006

Completion Date:

Related Keywords:

  • Advanced Malignancies
  • Tumors
  • EPO
  • Patupilone
  • Solid Tumors
  • Neoplasms

Name

Location

South Texas Accelerated Research TherapeuticsSan Antonio, Texas  78229
University of California San Diego/Moores Cancer CenterLa Jolla, California  92093-0987
Institute for Drug Development Cancer Therapy & Research Center/The University of Texas Health Science CenterSan Antonio, Texas  78229