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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00100256
Recruitment Status : Unknown
Verified January 2019 by Andarix Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : December 28, 2004
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Andarix Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE December 27, 2004
First Posted Date  ICMJE December 28, 2004
Last Update Posted Date January 10, 2019
Study Start Date  ICMJE January 2004
Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2017)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • maximum tolerated dose of Rhenium 188 P2045
  • safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy
Official Title  ICMJE Open Label Study of Single Dose Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy
Brief Summary 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Small Cell
  • Neoplasm Recurrence, Local
Intervention  ICMJE Drug: Rhenium (Re 188 P2045, BAY86-5284)
Infusion once only
Study Arms  ICMJE Experimental: Arm 1
Intervention: Drug: Rhenium (Re 188 P2045, BAY86-5284)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 9, 2017)
60
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
27
Estimated Study Completion Date  ICMJE April 2020
Primary Completion Date June 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00100256
Other Study ID Numbers  ICMJE 91168
306509
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andarix Pharmaceuticals
Study Sponsor  ICMJE Andarix Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andarix Study Director Andarix Pharmaceuticals
PRS Account Andarix Pharmaceuticals
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP