This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Andarix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00100256
First received: December 27, 2004
Last updated: June 5, 2017
Last verified: June 2017
December 27, 2004
June 5, 2017
January 2004
June 2004   (Final data collection date for primary outcome measure)
  • Maximum tolerated dose of Rhenium 188 P2045
  • Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045
Same as current
Complete list of historical versions of study NCT00100256 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy
Open Label Study of Single Dose Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy
The purpose of this study is to determine the maximum dose that is safely tolerated of the experimental drug Rhenium Re 188 P2045. This will be done by first treating patients at relatively low doses of Rhenium Re 188 P2045, observing them closely to assure that there are no bad side effects, then increasing the dose when we are confident that it is safe to do so.
We want to learn more about the side effect profile of both Technetium Tc 99m P2045 and Rhenium Re 188 P2045 and will do that by observing you closely after you receive the drug and by conducting multiple tests, as well as by asking you how you feel. We want to also learn if there is any benefit, in terms of lung cancer tumor reduction, as a result of treatment with Rhenium Re 188 P2045. This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
  • Lung Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Small Cell
  • Neoplasm Recurrence, Local
Drug: Rhenium (Re 188 P2045, BAY86-5284)
Infusion once only
Experimental: Arm 1
Intervention: Drug: Rhenium (Re 188 P2045, BAY86-5284)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
19
April 2018
June 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has histologically or cytologically documented Non-Small-Cell Lung Cancer (NSCLC) or Small-Cell Lung Cancer (SCLC) and has advanced or recurrent IIIb or IV NSCLC (adenocarcinoma, squamous cell carcinoma, large cell, mixed or not otherwise specified) or disseminated or recurrent SCLC or any lung cancer which has local recurrence.
  • Has documentation of progressive disease following prior chemotherapy or who refused to receive standard chemotherapy.
  • Has measurable tumor (at least 1 cm unidimensionally) in a previously non-irradiated area or, if in previously irradiated area, a substantial increase in size of tumor, based on CT scan within 8 weeks prior to enrollment; tumor in previously irradiated area only if it has increased by 50% or more from previous minimal diameter AND it is more than 8 weeks from the radiation.
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00100256
91168
306509
Not Provided
Not Provided
Not Provided
Andarix Pharmaceuticals
Andarix Pharmaceuticals
Not Provided
Study Director: Andarix Study Director Andarix Pharmaceuticals
Andarix Pharmaceuticals
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP