Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy
Open Label Study of Single Dose Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy
2 other identifiers
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2004
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 27, 2004
CompletedFirst Posted
Study publicly available on registry
December 28, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2025
CompletedNovember 7, 2022
October 1, 2022
5.5 years
December 27, 2004
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Maximum tolerated dose of Rhenium 188 P2045
Toxicity as determined by the analysis protocol
Over the first month post dose administration
Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045
Examination of clinical chemistry indicators as outlined in the protocol
Up to one year post study completion
Progression free survival in treated patients
Analyze tumor and disease progression after dosing
Up to one year post study completion
Study Arms (1)
Arm 1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andarix Study Director
Andarix Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2004
First Posted
December 28, 2004
Study Start
January 1, 2004
Primary Completion
June 20, 2009
Study Completion
April 20, 2025
Last Updated
November 7, 2022
Record last verified: 2022-10