Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Lung Neoplasms, Neoplasm Recurrence, Local
Conditions
Keywords
Advanced or recurrent stage IIIb or IV non small cell lung cancer, Disseminated or recurrent small cell lung cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGRhenium (Re 188 P2045, BAY86-5284)
Infusion once only
Sponsors
Andarix Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose of Rhenium 188 P2045 | Over the first month post dose administration | Toxicity as determined by the analysis protocol |
| Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045 | Up to one year post study completion | Examination of clinical chemistry indicators as outlined in the protocol |
| Progression free survival in treated patients | Up to one year post study completion | Analyze tumor and disease progression after dosing |
Countries
United States
Contacts
Primary ContactTrials Andarix Clinical Trials Contact
Backup ContactFor trial location information Andarix
Outcome results
None listed