Back to resultsRhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy
Primary Purpose
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rhenium (Re 188 P2045, BAY86-5284)
Sponsored by
About this trial
This is an interventional treatment trial for Lung Neoplasms focused on measuring Advanced or recurrent stage IIIb or IV non small cell lung cancer, Disseminated or recurrent small cell lung cancer
Eligibility 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.
Sites / Locations
- Recruiting
- Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Maximum tolerated dose of Rhenium 188 P2045
Toxicity as determined by the analysis protocol
Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045
Examination of clinical chemistry indicators as outlined in the protocol
Progression free survival in treated patients
Analyze tumor and disease progression after dosing
Secondary Outcome Measures
Full Information
NCT ID
NCT00100256
First Posted
December 27, 2004
Last Updated
October 31, 2022
Sponsor
Andarix Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00100256
Brief Title
Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2004 (undefined)
Primary Completion Date
June 20, 2009 (Actual)
Study Completion Date
April 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Andarix Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Neoplasm Recurrence, Local
Keywords
Advanced or recurrent stage IIIb or IV non small cell lung cancer, Disseminated or recurrent small cell lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rhenium (Re 188 P2045, BAY86-5284)
Intervention Description
Infusion once only
Primary Outcome Measure Information:
Title
Maximum tolerated dose of Rhenium 188 P2045
Description
Toxicity as determined by the analysis protocol
Time Frame
Over the first month post dose administration
Title
Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045
Description
Examination of clinical chemistry indicators as outlined in the protocol
Time Frame
Up to one year post study completion
Title
Progression free survival in treated patients
Description
Analyze tumor and disease progression after dosing
Time Frame
Up to one year post study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trials Andarix Clinical Trials Contact
Email
info@andarix.com
First Name & Middle Initial & Last Name or Official Title & Degree
For trial location information Andarix
Phone
617-957-9858
Email
info@andarix.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andarix Study Director
Organizational Affiliation
Andarix Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy
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