NCT00113113

Brief Summary

Cancer patients with liver or renal dysfunction will be treated with rubitecan capsules to define the maximum tolerated dose and the dose-limiting toxicity in this patient population, and to perform pharmacokinetic studies of rubitecan in this patient population.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2005

Completed
Last Updated

August 2, 2024

Status Verified

August 1, 2024

First QC Date

June 3, 2005

Last Update Submit

August 1, 2024

Conditions

Tumors

Keywords

rubitecanOrathecin9-nitrocamptothecinsolid tumorsorgan dysfunctionrenal dysfunctionhepatic dysfunctionRFS 2000

Interventions

RubitecanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient is at least 18 years of age.
  • The patient has histologically or cytologically proven malignancy recurrent or refractory to standard treatment or for which there is no standard therapy.
  • The patient has measurable disease.
  • The patient has sufficiently recovered from the acute toxic effects of previous chemotherapy, radiotherapy (no less than 3 weeks prior to randomization), and/or immunotherapy.
  • The patient's estimated life expectancy is at least 8 weeks.
  • The patient has a National Cancer Institute Common Toxicity Criteria (NCI CTC) Performance Status between 0 and 2.
  • The patient has adequate bone marrow function.
  • The patient must not have active central nervous system (CNS) metastases.

You may not qualify if:

  • The patient has any serious, uncontrolled intercurrent illness or infection.
  • The patient is receiving anti-retroviral therapy (HAART) for HIV infection.
  • The patient is pregnant or nursing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The Center for Cancer Care and Research

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

NeoplasmsRenal InsufficiencyLiver Diseases

Interventions

rubitecan

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDigestive System Diseases

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

June 3, 2005

First Posted

June 6, 2005

Study Start

August 1, 2001

Last Updated

August 2, 2024

Record last verified: 2024-08

Locations

US(2)