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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.
Sponsor:
Information provided by (Responsible Party):
Andarix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00100256
First received: December 27, 2004
Last updated: August 11, 2017
Last verified: August 2017
  Purpose
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 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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 [ Time Frame: 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 [ Time Frame: Up to one year post study completion ]
    Examination of clinical chemistry indicators as outlined in the protocol

  • Progression free survival in treated patients [ Time Frame: Up to one year post study completion ]
    Analyze tumor and disease progression after dosing


Enrollment: 60
Study Start Date: January 2004
Estimated Study Completion Date: April 2020
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. Andarix Pharmaceuticals is the sponsor of the trial.
  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100256

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

Additional Information:
Responsible Party: Andarix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00100256     History of Changes
Other Study ID Numbers: 91168
306509
Study First Received: December 27, 2004
Last Updated: August 11, 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
Carcinoma
Lung Neoplasms
Neoplasms
Recurrence
Carcinoma, Non-Small-Cell Lung
Neoplasm Recurrence, Local
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes

ClinicalTrials.gov processed this record on August 18, 2017