stop_circleTerminated/Withdrawn
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Neoplasm Recurrence, Local
Bayer Identifier:
91168
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
STUDY SPONSORSHIP TRANSFERRED - Rhenium Re 188 P2045 in Patients with Lung Cancer who have Received or Refused to Receive Prior Chemotherapy
Trial purpose
DISCLAIMER: This study was originally conducted and disclosed under Bayer sponsorship; sponsorship was however transferred to a new sponsor while the study was still ongoing. Therefore, this disclosure overview only reflects the study status at the last time that Bayer was responsible for the study – for the latest correct status and details of the study, please refer to the disclosure by the new sponsor under the study’s NCT number on www.ClinicalTrials.gov.
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.
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.
Key Participants Requirements
Sex
BothAge
21 YearsTrial summary
Enrollment Goal
19Trial Dates
January 2004 - April 2005Phase
Phase 1Could I Receive a placebo
NoProducts
Rhenium (Re 188 P2045, BAY86-5284)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Baltimore, 21201, United States | |
Recruiting | Iowa City, 52242, United States | |
Not yet recruiting | Iowa City, 52246, United States |
Primary Outcome
- Maximum tolerated dose of Rhenium 188 P2045enhanced_encryptionNoneSafety Issue:
- Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045enhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1