stop_circleTerminated/Withdrawn

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

Bayer Identifier:

91168

ClinicalTrials.gov Identifier:

NCT00100256

EudraCT Number:

Not Available

EU CT Number:

Not Available
STUDY SPONSORSHIP TRANSFERRED - Rhenium Re 188 P2045 in Patients with Lung Cancer who have Received or Refused to Receive Prior Chemotherapy

Trial purpose

DISCLAIMER: This study was originally conducted and disclosed under Bayer sponsorship; sponsorship was however transferred to a new sponsor while the study was still ongoing. Therefore, this disclosure overview only reflects the study status at the last time that Bayer was responsible for the study – for the latest correct status and details of the study, please refer to the disclosure by the new sponsor under the study’s NCT number on www.ClinicalTrials.gov.

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.

Key Participants Requirements

Sex

Both

Age

21 Years
  • - 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.

Trial summary

Enrollment Goal
19
Trial Dates
January 2004 - April 2005
Phase
Phase 1
Could I Receive a placebo
No
Products
Rhenium (Re 188 P2045, BAY86-5284)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Baltimore, 21201, United States
Recruiting
Iowa City, 52242, United States
Not yet recruiting
Iowa City, 52246, United States

Primary Outcome

  • Maximum tolerated dose of Rhenium 188 P2045
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    Safety Issue:
    None
  • Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045
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    Safety Issue:
    None

Trial design

Open Label Study of Single Dose Rhenium Re 188 P2045 in Patients with Lung Cancer who have Received or Refused to Receive Prior Chemotherapy
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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