Malignant MelanomaPhase 1/2NCT00327600
Safety and Efficacy Trial of Imexon Plus DTIC in Advanced Malignant Melanoma
A Phase 1/2 study testing imexon and DTIC in people with Malignant Melanoma, run by AmpliMed Corporation at 11 sites in United States.
Trial summary
AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- imexon and DTIC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 11 sitesUnited States
- Study dates
- Jul 2005to Dec 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Malignant melanoma; inoperable stage III or IV disease.
- Able to perform the activities of daily living.
- A projected life expectancy of at least 4 months.
- If female, neither pregnant nor nursing.
- Willing to use contraceptives to prevent pregnancy.
- Blood cell counts and blood chemistries in or near normal range.
Show all 11Show fewer
- Prior radiation is permitted.
- No other serious illnesses.
- No other active malignancy.
- No serious infections.
- No other current drug therapy for the cancer or steroid therapy.
Who cannot join
- No prior chemotherapy for the stage III or IV disease.
- Brain metastases
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
US Oncology Albany, New York Oncology
Albany, New York, 12208
University of CO Anschutz Cancer Pavilion
Aurora, Colorado, 80010
US Oncology Greenville, Cancer Centers of the Carolinas
Greenville, South Carolina, 29615
US Oncology Kettering
Kettering, Ohio, 45409
Investigational Site 009
Los Angeles, California, 90033
US Oncology, Virginia Oncology Assoc
Norfolk, Virginia, 23502
US Oncology Orlando, Cancer Centers of FL
Ocoee, Florida, 34761
Investigational Site 012
Salt Lake City, Utah, 84112
Investigational Site 002
Santa Monica, California, 90404
US Oncology Spokane, Cancer Care Northwest
Spokane, Washington, 99218
US Oncology, Tyler Cancer Center
Tyler, Texas, 75702
About this study
Official title: A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) Plus Dacarbazine (DTIC) in Chemotherapy Naive Patients With Unresectable Stage III or Stage IV Malignant Melanoma
AMP-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.
- Conditions
- Malignant Melanoma
- Being tested
- imexon, DTIC
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imexonDrug
DTICDrug
| Study group | Role | What they receive |
|---|---|---|
| imexon + DTIC | Experimental | Not described Receives: Drug: imexon; Drug: DTIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximally tolerated dose of imexon plus DTIC
determine the toxicity and tolerability of the combination
determine response rate and progression free survival
Secondary outcomes (1)
Determine effects of the drug combination on plasma thiol levels and other biomarkers
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 startJul 2005
- Primary completionJan 2007
- Study completionDec 2007
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 Malignant MelanomaStudies 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
- 68 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
- NCT00327600
- Sponsor's protocol ID
- AMP-005
- Status last verified
- Sep 2010
- First submitted
- 17 May 2006
- Last updated
- 15 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weber JS, Samlowski WE, Gonzalez R, Ribas A, Stephenson J, O'Day S, Sato T, Dorr R, Grenier K, Hersh E. A phase 1-2 study of imexon plus dacarbazine in patients with unresectable metastatic melanoma. Cancer. 2010 Aug 1;116(15):3683-91. doi: 10.1002/cncr.25119.
PubMed 20564083
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Trial of Amplimexon® (Imexon, Inj.) Plus Dacarbazine (DTIC) in Chemotherapy Naive Patients With Unresectable Stage III or Stage IV Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00327600
- Acronym / sponsor ID
- AMP-005
- Conditions
- Malignant Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- AmpliMed CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Dec 2007 (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-005 is a Phase 1b/2 clinical trial designed to evaluate whether the new drug, imexon, can be administered in combination with the approved drug, dacarbazine (DTIC), for the treatment of patients with stage III or IV inoperable melanoma. The Phase 1b part of the study is designed to determine whether the two drugs can be safely combined together, and the Phase 2 part of the study is designed to provide additional safety data and to gain an understanding of whether adding imexon to DTIC can improve the outcome for melanoma patients versus the findings from prior clinical studies of DTIC alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| imexon + DTIC | Experimental | Drug: imexon, Drug: DTIC |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Malignant melanoma; inoperable stage III or IV disease.
- Able to perform the activities of daily living.
- A projected life expectancy of at least 4 months.
- If female, neither pregnant nor nursing.
- Willing to use contraceptives to prevent pregnancy.
Key exclusion criteria (2 listed)
- No prior chemotherapy for the stage III or IV disease.
- 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 + DTIC |
| DTIC | Drug | imexon + DTIC |
Primary outcome
Determine the maximally tolerated dose of imexon plus DTIC
determine the toxicity and tolerability of the combination
determine response rate and progression free survival
1 secondary outcome
Determine effects of the drug combination on plasma thiol levels and other biomarkers
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 15 Sep 2010.
- Results publication: PubMed 20564083Weber JS, Samlowski WE, Gonzalez R, Ribas A, Stephenson J, O'Day S, Sato T, Dorr R, Grenier K, Hersh E. A phase 1-2 study of imexon plus dacarbazine in patients with unresectable metastatic melanoma. Cancer. 2010 Aug 1;116(15):3683-91. doi: 10.1002/cncr.25119.
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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
11 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 imexon and DTIC in people with Malignant Melanoma, run by AmpliMed Corporation at 11 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 11 inclusion and 2 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 15 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
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 of imexon plus DTIC. 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?
On the ClinicalTrials.gov record for NCT00327600, 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 15 Sep 2010.