Clinical Trials Logo
  1. Home
  2. Solid Tumors
  3. NCT00426140
  4. Details
NCT00426140 Clinical Trial

Pharmacokinetics of Patupilone After a Single Intravenous Administration in Patients With Advance Solid Tumor Malignancies.

Solid Tumors Clinical Trial

Official title:
An Open-label Single Center Study to Characterize the Absorption, Distribution, Metabolism, and Elimination (ADME) of Patupilone (EPO906) After a Single Intravenous Administration of 10 mg/m2 [14C] Patupilone in Patients With Advanced Solid Tumor Malignancies.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00426140
Other study ID # CEPO906A2122
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 2006

Study information
Verified date April 2010
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to characterize the distribution, metabolism, and elimination (ADME) of Patupilone after a single intravenous administration in patients with advanced solid tumor malignancies

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date
Est. primary completion date November 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 18 years or older 2. 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. 3. Adequate hematological laboratory parameters 4. No major impairment of renal or hepatic function 5. Female patients must have a negative serum pregnancy test at screening. Exclusion Criteria: 1. Severe and/or uncontrolled medical disease; 2. Severe cardiac insufficiency with uncontrolled and/or unstable cardiac or coronary artery disease; 3. Known diagnosis of human immunodeficiency virus (HIV) infection; 4. Presence of any other active or suspected acute or chronic uncontrolled infection; 5. Symptomatic brain metastases or leptomeningeal disease. Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Patupilone

Locations
Country Name City State
United States Cancer Therapy and Research Center, Institution for Drug Development San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To characterize the pharmacokinetic profile of patupilone including any potential metabolite(s) in blood/plasma as well as the total radioactivity in blood and plasma. one week
Secondary Safety and tolerability will be assessed by AEs, SAEs and out of range lab values. every 6 weeks
Secondary Radiological scans will also be completed at approximately 6 weeks to asses anti-tumor activity. every 6 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT00750841 - Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours Phase 1
Withdrawn NCT05419817 - Pembrolizumab With Sitravatinib in Recurrent Endometrial Cancer and Other Solid Tumors With Deficient Mismatch Repair System Phase 2
Completed NCT02828930 - A Study to Determine the Excretion Balance, Pharmacokinetics, Metabolism and Absolute Oral Bioavailability of a Single Oral Dose of [14C]-Labeled Idasanutlin and an Intravenous Tracer Dose of [13C]-Labeled Idasanutlin in a Single Cohort of Participants With Solid Tumors (Malignancies) Phase 1
Completed NCT01197170 - Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance Phase 1
Completed NCT03258515 - A Study to Investigate the Effect of Single Dose of AZD6094 (600 mg) on Cardiac Repolarization in Healthy Volunteers Phase 1
Terminated NCT03225105 - M3541 in Combination With Radiotherapy in Solid Tumors Phase 1
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Completed NCT01878890 - Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure. Phase 1
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT03634982 - Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors Phase 1
Recruiting NCT04685226 - A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Recruiting NCT06036121 - A Study of ADRX-0706 in Select Advanced Solid Tumors Phase 1
Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Completed NCT01528046 - Metformin in Children With Relapsed or Refractory Solid Tumors Phase 1
Recruiting NCT05325866 - A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression Phase 1/Phase 2
Recruiting NCT04557449 - Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors Phase 1/Phase 2
Completed NCT02759640 - A Phase I Trial of HS-10241 in Solid Tumors Phase 1
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Withdrawn NCT01940601 - Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors Phase 2

External Links