Recruiting
Phase 1
Phase 2

Rhenium Re 188 P2045

Sponsor:

Andarix Pharmaceuticals

Code:

NCT00100256

Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Small Cell

Neoplasm Recurrence, Local

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Rhenium (Re 188 P2045, BAY86-5284)

Study Details

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.

Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Small Cell

Neoplasm Recurrence, Local

Study ID

NCT00100256

Start date

Jan, 2004

Status verified date

Oct, 2022

Completion date

Apr 20, 2025

Anticipated

Primary completion date

Jun 20, 2009

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1

Interventions

Rhenium (Re 188 P2045, BAY86-5284)

Infusion once only

Primary outcome measure

  • Maximum tolerated dose of Rhenium 188 P2045 [ Time Frame: Over the first month post dose administration ]
  • Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045 [ Time Frame: Up to one year post study completion ]
  • Progression free survival in treated patients [ Time Frame: Up to one year post study completion ]

Central Contacts and Locations

Central contacts

Trials Andarix Clinical Trials Contact

info@andarix.com

For trial location information Andarix

617-957-9858info@andarix.com

Locations

Recruiting

Iowa City, Iowa, United States, 52242

Recruiting

Baltimore, Maryland, United States, 21201

More Information

Sponsor

Andarix Pharmaceuticals

Last update posted

Nov 7, 2022

Last verified

Oct, 2022

Keywords

  • Advanced or recurrent stage IIIb or IV non small cell lung cancer
  • Disseminated or recurrent small cell lung cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Andarix Pharmaceuticals on 2022-11-07.