Trial Condition(s):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Neoplasm Recurrence, Local
STUDY SPONSORSHIP TRANSFERRED - Rhenium Re 188 P2045 in Patients with Lung Cancer who have Received or Refused to Receive Prior Chemotherapy
Bayer Identifier:
91168
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Baltimore, United States, 21201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Iowa City, United States, 52242 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Iowa City, United States, 52246 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Open Label Study of Single Dose Rhenium Re 188 P2045 in Patients with Lung Cancer who have Received or Refused to Receive Prior Chemotherapy
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Maximum tolerated dose of Rhenium 188 P2045Timeframe:
- Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045Timeframe:
Additional Information
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