Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Open Label Study of Single Dose Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy

Conditions
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Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Neoplasm Recurrence, Local

Intervention / Treatment
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* Drug: Rhenium (Re 188 P2045, BAY86-5284)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Rhenium (Re 188 P2045, BAY86-5284)<br>* Infusion once only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced or recurrent stage IIIb or IV non small cell lung cancer, Disseminated or recurrent small cell lung cancer