Lung NeoplasmsPhase 1/2NCT00100256
Rhenium Re 188 P2045 in Patients With Lung Cancer Who Have Received or Refused to Receive Prior Chemotherapy
A Phase 1/2 study testing Rhenium (Re 188 P2045, BAY86-5284) in people with Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Andarix Pharmaceuticals at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell
- What is being tested?
- Rhenium (Re 188 P2045, BAY86-5284)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2004to 20 Apr 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Trials Andarix Clinical Trials Contact contact
United States2 sites, 2 recruiting
- Recruiting
Study site
Baltimore, Maryland, 21201
- Recruiting
Study site
Iowa City, Iowa, 52242
About this study
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
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.
Read the 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.
- Conditions
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Neoplasm Recurrence, Local
- Being tested
- Rhenium (Re 188 P2045, BAY86-5284)
- Keywords
- Advanced or recurrent stage IIIb or IV non small cell lung cancer, Disseminated or recurrent small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Neoplasm Recurrence, Local, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhenium (Re 188 P2045, BAY86-5284)Drug
Infusion once only
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Rhenium (Re 188 P2045, BAY86-5284) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of Rhenium 188 P2045
Toxicity as determined by the analysis protocol
Measured: 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
Measured: Up to one year post study completion
Progression free survival in treated patients
Analyze tumor and disease progression after dosing
Measured: Up to one year post study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2004 (estimated)
- Study startJan 2004
- Primary completion20 Jun 2009
- Study completion20 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andarix Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andarix Study Director, Study director, Andarix Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100256
- Sponsor's protocol ID
- 91168
- Other IDs
- 306509
- Status last verified
- Oct 2022
- First submitted
- 27 Dec 2004
- Last updated
- 7 Nov 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00100256
- Acronym / sponsor ID
- 91168
- Conditions
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Andarix PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- 20 Jun 2009 (actual)
- Study completion
- 20 Apr 2025 (estimated)
- First posted
- 28 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Rhenium (Re 188 P2045, BAY86-5284) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhenium (Re 188 P2045, BAY86-5284)Infusion once only | Drug | Arm 1 |
Primary outcome
Maximum tolerated dose of Rhenium 188 P2045
Time frame: Over the first month post dose administration
Toxicity as determined by the analysis protocol
Safety of Technetium Tc 99m P2045 and Rhenium Re 188 P2045
Time frame: Up to one year post study completion
Examination of clinical chemistry indicators as outlined in the protocol
Progression free survival in treated patients
Time frame: Up to one year post study completion
Analyze tumor and disease progression after dosing
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trials Andarix Clinical Trials Contact contact
Andarix Study Director study director
Andarix Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rhenium (Re 188 P2045, BAY86-5284) in people with Lung Neoplasms and Carcinoma, Non-Small-Cell Lung, run by Andarix Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trials Andarix Clinical Trials Contact (info@andarix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of Rhenium 188 P2045 (time frame: Over the first month post dose administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.