Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 1/12/2019 |
| Start Date: | January 2004 |
| End Date: | April 2020 |
Open Label Study of Single Dose Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy
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.
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.
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.
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.
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2
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