Neoplasm MetastasisPhase 1NCT00327223
Safety Study of Imexon Treatment of Patients With Metastatic or Disseminated Malignancy
A Phase 1 study testing imexon in people with Neoplasm Metastasis, run by AmpliMed Corporation at 4 sites in United States.
Trial summary
AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastasis
- What is being tested?
- imexon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2005to Oct 2006
- 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
- Previously treated malignant disease of any type.
- 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.
Show all 12Show fewer
- 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
- No active brain metastases.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
US Oncology Albany, New York Oncology
Albany, New York, 12208
US Oncology Indiana
Indianapolis, Indiana, 46227
Investigational Site 014
Temple, Texas, 76508
US Oncology, Tyler Cancer Center
Tyler, Texas, 75702
About this study
Official title: A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Administered Daily for 5 Days Every 3 Weeks to Patients With Metastatic Cancer or Disseminated Malignancy
AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.
- Conditions
- Neoplasm Metastasis
- Being tested
- imexon
- Keywords
- Metastatic cancer, Disseminated malignant disease
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imexonDrug
| Study group | Role | What they receive |
|---|---|---|
| imexon | Experimental | Dose escalation of imexon Receives: Drug: imexon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximally tolerated dose
determine the pharmacokinetics
determine the toxicity of the drug on the designated schedule
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 startNov 2005
- Primary completionSep 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AmpliMed Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Evan Hersh, MD, Study director, AmpliMed Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327223
- Sponsor's protocol ID
- AMP-011
- Status last verified
- Mar 2008
- First submitted
- 17 May 2006
- Last updated
- 14 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Administered Daily for 5 Days Every 3 Weeks to Patients With Metastatic Cancer or Disseminated Malignancy
- ClinicalTrials.gov ID
- NCT00327223
- Acronym / sponsor ID
- AMP-011
- Conditions
- Neoplasm Metastasis
- Keywords
- Metastatic cancer, Disseminated malignant disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AmpliMed CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Oct 2006 (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.
AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| imexon | Experimental | Drug: imexonDose escalation of 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)
- Previously treated malignant disease of any type.
- 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)
- No 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 |
|---|---|---|
| imexon | Drug | imexon |
Primary outcome
Determine the maximally tolerated dose
determine the pharmacokinetics
determine the toxicity of the drug on the designated schedule
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 14 Mar 2008.
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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.
Evan Hersh, MD study director
AmpliMed Corporation
4 sites 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 in people with Neoplasm Metastasis, run by AmpliMed Corporation at 4 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 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 14 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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 maximally tolerated dose. 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 14 Mar 2008.