Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy
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ClinicalTrials.gov Identifier: NCT00100256
Recruitment Status : Unknown
Verified January 2019 by Andarix Pharmaceuticals. Recruitment status was: Active, not recruiting
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.
Condition or disease
Lung NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Small CellNeoplasm Recurrence, Local
Drug: Rhenium (Re 188 P2045, BAY86-5284)
Phase 1Phase 2
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. Andarix Pharmaceuticals is the sponsor of the trial.
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Ages Eligible for Study:
21 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Advanced or recurrent stage IIIb or IV non small cell lung cancer
Disseminated or recurrent small cell lung cancer
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Small Cell
Neoplasm Recurrence, Local
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases