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| ID | Type | Description | Link |
|---|---|---|---|
| 306509 |
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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. Andarix Pharmaceuticals is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhenium (Re 188 P2045, BAY86-5284) | Drug | Infusion once only |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose of Rhenium 188 P2045 | Toxicity as determined by the analysis protocol | Over the first month post dose administration |
| Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045 | Examination of clinical chemistry indicators as outlined in the protocol | Up to one year post study completion |
| Progression free survival in treated patients | Analyze tumor and disease progression after dosing | Up to one year post study completion |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trials Andarix Clinical Trials Contact | Contact | info@andarix.com | ||
| For trial location information Andarix | Contact | 617-957-9858 | info@andarix.com |
| Name | Affiliation | Role |
|---|---|---|
| Andarix Study Director | Andarix Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recruiting | Iowa City | Iowa | 52242 | United States | ||
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| Recruiting |
| Baltimore |
| Maryland |
| 21201 |
| United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D018288 | Carcinoma, Small Cell |
| D009364 | Neoplasm Recurrence, Local |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012211 | Rhenium |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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