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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00100256
• Other study ID #: 91168
• Secondary ID: 306509
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 2004
• Est. completion date: April 20, 2025

Study information

• Verified date: October 2022
• Source: Andarix Pharmaceuticals
• Contact: Trials Andarix Clinical Trials Contact
• Email: info[@]andarix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 20, 2025
• Est. primary completion date: June 20, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Small Cell
• Lung Neoplasms
• Neoplasm Recurrence, Local
• Neoplasms
• Recurrence

Intervention

Drug:
• Rhenium (Re 188 P2045, BAY86-5284)
Infusion once only

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Andarix Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of Rhenium 188 P2045	Toxicity as determined by the analysis protocol	Over the first month post dose administration
Primary	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
Primary	Progression free survival in treated patients	Analyze tumor and disease progression after dosing	Up to one year post study completion