Non-small Cell Lung CancerPhase 1NCT00327288
Safety Study of Imexon Plus Docetaxel in Lung, Breast or Prostate Cancer Patients
A Phase 1 study testing imexon and docetaxel in people with Non-small Cell Lung Cancer and Breast Cancer, run by AmpliMed Corporation at 1 site in United States.
Trial summary
Protocol AMP-010 is a Phase 1b study of imexon plus docetaxel for patients with previously treated breast cancer, previously treated lung cancer or hormone refractory prostate cancer. Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for these cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Breast Cancer, Prostate Cancer
- What is being tested?
- imexon and docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jul 2008
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be diagnosed with previously treated breast, lung, or prostate cancer where docetaxel is indicated.
- Prior treatment; at least one prior regimen required.
- Able to perform the activities of daily living.
- Off prior cancer therapy for at least 4 weeks.
- If female neither pregnant nor nursing.
- Willing to use contraceptives to prevent pregnancy.
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- No other serious illnesses.
- No other active malignancy.
- No serious infections.
- No other current drug therapy for the cancer.
- Blood counts and blood chemistries in or near normal range.
- Prior radiation is permitted.
Who cannot join
- Active brain metastases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Taxotere® (Docetaxel) in Previously Treated Inoperable Stage III and Stage IV Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic Previously Treated Breast Cancer or Hormone Refractory Prostate Cancer
Protocol AMP-010 is a Phase 1b study of imexon plus docetaxel for patients with previously treated breast cancer, previously treated lung cancer or hormone refractory prostate cancer. Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for these cancers. The imexon is administered on days 1-5 and the docetaxel on day 1 of every 3 week cycle. The objective of the protocol is to determine the highest dose of imexon which can be given with a full dose of docetaxel, and to provide information to enable the design of a future study focused on one or more specific cancer types.
- Conditions
- Non-small Cell Lung Cancer, Breast Cancer, Prostate Cancer
- Being tested
- imexon, docetaxel
- Keywords
- Hormone refractory prostate cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imexonDrug
Also called Amplimexon
IV variable dosages, days 1-5 every 21 days for duration of study
docetaxelDrug
Also called Taxotere
IV once every 21 days for duration of study
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Docetaxel plus imexon Receives: Drug: imexon; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the tolerability
Measured: duration of study
determine the maximally tolerated dose (MTD)
Measured: duration of study
determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel
Measured: duration of study
correlate changes in plasma glutathione (GSH) levels with imexon dose levels
Measured: cycle 1
Secondary outcomes (1)
Record any objective tumor responses which may occur
Measured: duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startOct 2005
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- AmpliMed Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327288
- Sponsor's protocol ID
- AMP-010
- Status last verified
- Jun 2015
- First submitted
- 17 May 2006
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Moulder S, Dhillon N, Ng C, Hong D, Wheler J, Naing A, Tse S, La Paglia A, Dorr R, Hersh E, Boytim M, Kurzrock R. A phase I trial of imexon, a pro-oxidant, in combination with docetaxel for the treatment of patients with advanced breast, non-small cell lung and prostate cancer. Invest New Drugs. 2010 Oct;28(5):634-40. doi: 10.1007/s10637-009-9273-1. Epub 2009 Jun 6.
PubMed 19499186
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Taxotere® (Docetaxel) in Previously Treated Inoperable Stage III and Stage IV Non-Small Cell Lung Cancer (NSCLC), Locally Advanced or Metastatic Previously Treated Breast Cancer or Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00327288
- Acronym / sponsor ID
- AMP-010
- Conditions
- Non-small Cell Lung Cancer, Breast Cancer, Prostate Cancer
- Keywords
- Hormone refractory prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- AmpliMed CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 18 May 2006 (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.
Protocol AMP-010 is a Phase 1b study of imexon plus docetaxel for patients with previously treated breast cancer, previously treated lung cancer or hormone refractory prostate cancer. Docetaxel is approved by the Food and Drug Administration (FDA) as a second line therapy for these cancers. The imexon is administered on days 1-5 and the docetaxel on day 1 of every 3 week cycle. The objective of the protocol is to determine the highest dose of imexon which can be given with a full dose of docetaxel, and to provide information to enable the design of a future study focused on one or more specific cancer types.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: imexon, Drug: docetaxelDocetaxel plus imexon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Be diagnosed with previously treated breast, lung, or prostate cancer where docetaxel is indicated.
- Prior treatment; at least one prior regimen required.
- Able to perform the activities of daily living.
- Off prior cancer therapy for at least 4 weeks.
- If female neither pregnant nor nursing.
Key exclusion criteria (1 listed)
- Active brain metastases.
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 |
|---|---|---|
| imexonAlso: AmplimexonIV variable dosages, days 1-5 every 21 days for duration of study | Drug | A |
| docetaxelAlso: TaxotereIV once every 21 days for duration of study | Drug | A |
Primary outcome
Determine the tolerability
Time frame: duration of study
determine the maximally tolerated dose (MTD)
Time frame: duration of study
determine the dose limiting toxicities (DLT) of increasing doses of imexon in combination with standard doses of docetaxel
Time frame: duration of study
correlate changes in plasma glutathione (GSH) levels with imexon dose levels
Time frame: cycle 1
1 secondary outcome
Record any objective tumor responses which may occur
Time frame: duration of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Results publication: PubMed 19499186Moulder S, Dhillon N, Ng C, Hong D, Wheler J, Naing A, Tse S, La Paglia A, Dorr R, Hersh E, Boytim M, Kurzrock R. A phase I trial of imexon, a pro-oxidant, in combination with docetaxel for the treatment of patients with advanced breast, non-small cell lung and prostate cancer. Invest New Drugs. 2010 Oct;28(5):634-40. doi: 10.1007/s10637-009-9273-1. Epub 2009 Jun 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing imexon and docetaxel in people with Non-small Cell Lung Cancer and Breast Cancer, run by AmpliMed Corporation at 1 site 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 12 inclusion and 1 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: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the tolerability (time frame: duration of study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00327288, which also lists 1 linked publication.
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 24 Jun 2015.