CancerPhase 1NCT00259818
Dose Escalation Study of EM-1421 for the Treatment of Recurrent or Refractory Solid Tumors
A Phase 1 study testing EM-1421 in people with Cancer, run by Erimos Pharmaceuticals at 3 sites in United States.
Trial summary
This is a Phase I, dose escalation study of EM-1421 administered by intravenous infusion (IV) for five consecutive days every 28 days to patients with solid tumors refractory to current therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- EM-1421
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2005to Jan 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
- Male or female subjects ≥ 18 years of age.
- Subjects with documented evidence of cancer with clinically evaluable disease. Cancer can be recurrent after primary treatment with surgery, radiation therapy, and/or chemotherapy and may include those patients for whom no standard or curative therapy exists.
- Measurable tumor by imaging (computed tomography [CT] per Response Evaluation Criteria in Solid Tumors [RECIST] criteria).
- Life expectancy of at least 3 months in the Investigator's opinion.
- Negative pregnancy test, if in women of childbearing potential, within one week of starting therapy.
- Subjects who have provided written informed consent to participate in the study.
- ECOG performance status of 0, 1, or 2.
- Absolute neutrophil ≥ 1500 cells/µL, hemoglobin ≥ 9 gm/dl, platelets ≥ 100,000/µL, ALT/AST ≤ 3 x ULN (upper limit of the normal range) unless involved with tumor then < 5 x ULN, bilirubin ≤ 1.5 x ULN, and creatinine ≤ 1.5 x ULN.
Who cannot join
- Women who are pregnant or breast-feeding (women of child-bearing potential must have a negative serum pregnancy test within one week of entering the study.)
- Women of child-bearing potential who are unwilling to use two medically acceptable forms of contraception during the course of the study (surgical sterilization, approved hormonal contraceptives, or barrier method with spermicide).
- Treatment with a prior investigational agent within 28 days of entering the study.
- Subjects unable to comply with the study requirements.
- Subjects with a known sensitivity to any of the study medication components.
- Prior chemotherapy, radiation therapy, or surgery for the primary tumor within 28 days of dosing and/or has not recovered from prior therapy toxicities - with the exception of non-experimental chronic hormone therapy for currently progressive metastatic prostate cancer. However, local radiation to a site of symptomatic disease will be acceptable if it has been completed at least 14 days prior to study drug initiation and subjects have recovered from all treatment-related side effects.
- Subjects exhibiting any of the following: a marked baseline prolongation of QT/QTc interval (repeated demonstration of a calculated QTc interval > 450), a history of additional risk factors for torsades de pointes (TdP) (e.g., heart failure, hypokalemia, family history of long QT syndrome), and subjects unable or unwilling to refrain from using medications that are known to prolong the QT/QTc ratio during the course of the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sarah Cannon Cancer Center
Nashville, Tennessee
Premiere Oncology of Arizona
Scottsdale, Arizona
Albert Einstein College of Medicine
The Bronx, New York
About this study
Official title: An Open-Label Phase I Dose Escalation Study of Intravenous Infusion of Tetra-O-Methyl Nordihydroguaiaretic Acid (EM-1421) in Subjects With Refractory Malignant Tumors
This is a Phase I, dose escalation study of EM-1421 administered by intravenous infusion (IV) for five consecutive days every 28 days to patients with solid tumors refractory to current therapies. There have been no previous human studies of intravenous (into one's vein) EM-1421 treatment; however, lab research (research in test tubes and/or animals) suggests that EM-1421 has shown some activity against tumors in animals. This activity in animal models suggests that EM-1421 may be a useful chemotherapy for human cancer.
The primary objective of this study is to determine the safety and maximum tolerated dose of EM-1421 given by intravenous infusion. The efficacy of the treatment will also be measured.
- Conditions
- Cancer
- Being tested
- EM-1421
- Keywords
- Refractory, Solid Tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EM-1421Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Maximum tolerated dose
Secondary outcomes (4)
Pharmacokinetic parameters
Pharmacodynamic parameters
Anti-tumor activity of regimen
Feasibility of regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startDec 2005
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erimos Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Neil Frazer, MB, Erimos Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259818
- Sponsor's protocol ID
- EM-1421 #101
- Status last verified
- Jan 2008
- First submitted
- 30 Nov 2005
- Last updated
- 24 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase I Dose Escalation Study of Intravenous Infusion of Tetra-O-Methyl Nordihydroguaiaretic Acid (EM-1421) in Subjects With Refractory Malignant Tumors
- ClinicalTrials.gov ID
- NCT00259818
- Acronym / sponsor ID
- EM-1421 #101
- Conditions
- Cancer
- Keywords
- Refractory, Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Erimos PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Jan 2008 (actual)
- First posted
- 1 Dec 2005 (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.
This is a Phase I, dose escalation study of EM-1421 administered by intravenous infusion (IV) for five consecutive days every 28 days to patients with solid tumors refractory to current therapies. There have been no previous human studies of intravenous (into one's vein) EM-1421 treatment; however, lab research (research in test tubes and/or animals) suggests that EM-1421 has shown some activity against tumors in animals. This activity in animal models suggests that EM-1421 may be a useful chemotherapy for human cancer.
The primary objective of this study is to determine the safety and maximum tolerated dose of EM-1421 given by intravenous infusion. The efficacy of the treatment will also be measured.
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 (8 listed)
- Male or female subjects ≥ 18 years of age.
- Subjects with documented evidence of cancer with clinically evaluable disease. Cancer can be recurrent after primary treatment with surgery, radiation therapy, and/or chemotherapy and may include those patients for whom no standard or curative therapy exists.
- Measurable tumor by imaging (computed tomography [CT] per Response Evaluation Criteria in Solid Tumors [RECIST] criteria).
- Life expectancy of at least 3 months in the Investigator's opinion.
- Negative pregnancy test, if in women of childbearing potential, within one week of starting therapy.
Key exclusion criteria (7 listed)
- Women who are pregnant or breast-feeding (women of child-bearing potential must have a negative serum pregnancy test within one week of entering the study.)
- Women of child-bearing potential who are unwilling to use two medically acceptable forms of contraception during the course of the study (surgical sterilization, approved hormonal contraceptives, or barrier method with spermicide).
- Treatment with a prior investigational agent within 28 days of entering the study.
- Subjects unable to comply with the study requirements.
- Subjects with a known sensitivity to any of the study medication components.
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 |
|---|---|---|
| EM-1421 | Drug | – |
Primary outcome
Safety
Maximum tolerated dose
4 secondary outcomes
Pharmacokinetic parameters
Pharmacodynamic parameters
Anti-tumor activity of regimen
Feasibility of regimen
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 Jan 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.
Neil Frazer, MB
Erimos Pharmaceuticals
3 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 EM-1421 in people with Cancer, run by Erimos Pharmaceuticals at 3 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 8 inclusion and 7 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 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Safety. 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?
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 Jan 2008.