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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Andarix Pharmaceuticals Identifier:
First received: December 27, 2004
Last updated: June 5, 2017
Last verified: June 2017
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 Intervention Phase
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Carcinoma, Small Cell Neoplasm Recurrence, Local Drug: Rhenium (Re 188 P2045, BAY86-5284) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Open Label Study of Single Dose Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy

Resource links provided by NLM:

Further study details as provided by Andarix Pharmaceuticals:

Primary Outcome Measures:
  • Maximum tolerated dose of Rhenium 188 P2045
  • Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045

Enrollment: 19
Study Start Date: January 2004
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Rhenium (Re 188 P2045, BAY86-5284)
Infusion once only

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. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, the sponsor of the trial.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00100256

United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Andarix Pharmaceuticals
Study Director: Andarix Study Director Andarix Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Andarix Pharmaceuticals Identifier: NCT00100256     History of Changes
Other Study ID Numbers: 91168
Study First Received: December 27, 2004
Last Updated: June 5, 2017

Keywords provided by Andarix Pharmaceuticals:
Advanced or recurrent stage IIIb or IV non small cell lung cancer
Disseminated or recurrent small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Small Cell
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Recurrence, Local
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes processed this record on June 26, 2017