Pancreatic AdenocarcinomaPhase 1NCT00327327
Safety Study of Imexon Plus Gemcitabine in Untreated Pancreatic Adenocarcinoma
A Phase 1 study testing imexon and gemcitabine in people with Pancreatic Adenocarcinoma, run by AmpliMed Corporation at 9 sites in United States.
Trial summary
AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- imexon and gemcitabine
- Type of treatment
- Injection or infusion
- How many people
- 105 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2004to Oct 2009
- 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
- Inoperable cancer of the pancreas.
- Blood cell counts and blood chemistries in or near normal range.
- Able to perform the activities of daily living.
- A projected life expectancy of at least 2 months.
- 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 current other drug therapy for the cancer or steroid therapy.
- Prior radiation is permitted as is chemotherapy given during radiation or to prevent relapse after surgical removal of the disease.
Who cannot join
- Prior chemotherapy for metastatic disease.
- Brain metastases
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
US Oncology Albany, New York Oncology
Albany, New York, 12208
Univ of Michigan
Ann Arbor, Michigan, 48109
US Oncology Indiana
Indianapolis, Indiana, 46227
US Oncology Kettering
Kettering, Ohio, 45409
US Oncology, Virginia Oncology Assoc
Norfolk, Virginia, 23502
US Oncology Orlando, Cancer Centers of FL
Ocoee, Florida, 34761
Fox Chase Cancer Ctr.
Philadelphia, Pennsylvania, 19111
Arizona Clinical Research Center
Tucson, Arizona, 85715
US Oncology Northwest, Northwest Cancer Specialists
Vancouver, Washington, 98684
About this study
Official title: A Phase 1 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma
AMP-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the highest doses of the two drugs that can be safely combined together.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- imexon, gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imexonDrug
30-60 minutes IV, days 1,8,15 every 28 days
gemcitabineDrug
30 minutes IV, days 1,8,15 every 28 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine maximally tolerated dose (MTD)
Measured: until MTD reached
determine dose limiting toxicities.
Measured: until MTD reached
Secondary outcomes (3)
Changes in plasma thiol levels
Measured: until MTD reached
pharmacokinetics
Measured: until MTD reached
objective tumor responses.
Measured: until MTD reached
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 startFeb 2004
- Primary completionOct 2009
- Study completionOct 2009
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 Pancreatic AdenocarcinomaStudies 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- AmpliMed Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Zalupski, MD, Principal investigator, University of MichiganSteven Cohen, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327327
- Sponsor's protocol ID
- AMP-004
- Status last verified
- Sep 2010
- First submitted
- 17 May 2006
- Last updated
- 15 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cohen SJ, Zalupski MM, Modiano MR, Conkling P, Patt YZ, Davis P, Dorr RT, Boytim ML, Hersh EM. A phase I study of imexon plus gemcitabine as first-line therapy for advanced pancreatic cancer. Cancer Chemother Pharmacol. 2010 Jul;66(2):287-94. doi: 10.1007/s00280-009-1162-y. Epub 2009 Oct 24.
PubMed 19855966
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 Trial of Amplimexon® (Imexon, Inj.) Plus Gemcitabine in Advanced, Previously Untreated Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00327327
- Acronym / sponsor ID
- AMP-004
- Conditions
- Pancreatic Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- AmpliMed CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (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-004 is a Phase 1b dose escalation trial designed to evaluate the safety of the new drug imexon in combination with an approved drug, gemcitabine, for the treatment of patients with previously untreated pancreatic cancer. The treatment consists of dosing with both imexon and gemcitabine on days 1, 8, and 15 of each 28 day cycle. The study is designed to determine the highest doses of the two drugs that can be safely combined together.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Inoperable cancer of the pancreas.
- Blood cell counts and blood chemistries in or near normal range.
- Able to perform the activities of daily living.
- A projected life expectancy of at least 2 months.
- If female, neither pregnant nor nursing.
Key exclusion criteria (2 listed)
- Prior chemotherapy for metastatic 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 |
|---|---|---|
| imexon30-60 minutes IV, days 1,8,15 every 28 days | Drug | – |
| gemcitabine30 minutes IV, days 1,8,15 every 28 days | Drug | – |
Primary outcome
Determine maximally tolerated dose (MTD)
Time frame: until MTD reached
determine dose limiting toxicities.
Time frame: until MTD reached
3 secondary outcomes
Changes in plasma thiol levels
Time frame: until MTD reached
pharmacokinetics
Time frame: until MTD reached
objective tumor responses.
Time frame: until MTD reached
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 19855966Cohen SJ, Zalupski MM, Modiano MR, Conkling P, Patt YZ, Davis P, Dorr RT, Boytim ML, Hersh EM. A phase I study of imexon plus gemcitabine as first-line therapy for advanced pancreatic cancer. Cancer Chemother Pharmacol. 2010 Jul;66(2):287-94. doi: 10.1007/s00280-009-1162-y. Epub 2009 Oct 24.
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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.
Mark Zalupski, MD principal investigator
University of Michigan
Steven Cohen, MD principal investigator
Fox Chase Cancer Center
9 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 and gemcitabine in people with Pancreatic Adenocarcinoma, run by AmpliMed Corporation at 9 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 9 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 maximally tolerated dose (MTD) (time frame: until MTD reached). The study lists 2 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 NCT00327327, 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.