CancerPhase 2NCT00101621
Pilot Study to Evaluate the Safety and Analgesic Activity of M40403 Co-Administered With an Opioid Agent for Cancer Pain
A Phase 2 study testing M40403 in people with Cancer and Pain, run by MetaPhore Pharmaceuticals.
Trial summary
M40403 was found to be effective in reducing pain in animal models and in clinical studies of subjects who were experiencing pain after dental surgery. The proposed study is designed to investigate the efficacy and safety of M40403 when co-administered with an opioid in subjects with pain due to cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- M40403
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Aug 2004to Aug 2005
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has somatic or visceral pain due to solid tumor cancers (adrenal, basal cell, and breast cancers; transitional cell carcinoma of the bladder or uroepithelium; cholangiocarcinoma; small intestine/colon/rectal cancers; adenocarcinoma, esophageal/gastric cancers; hepatocellular, ovarian, pancreatic, and prostate cancers; bony/soft tissue sarcomas; small cell lung cancer; non small cell lung cancer; and adenocarcinomas of unknown primary origin).
- Has moderate to severe pain as measured by the Pain Intensity Assessment (categorical scale), and a pain intensity measurement of greater than or equal to 40 mm by visual analog scale (VAS) prior to the morning dose of pain medication.
- Stable chronic cancer pain as evidenced by a stable, scheduled opioid regimen over 7 days prior to treatment with study medication and fewer than 3 rescue doses per day averaged over the 3 days prior to treatment with study medication.
- Currently taking morphine, hydromorphone, oxycodone or an oxycodone/acetaminophen combination for the treatment of cancer pain.
- Age 18 or older.
- Performance status of 0 to 2 by Eastern Cooperative Oncology Group (ECOG) scale.
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- If taking concomitant medication, subject has been on a steady regimen for the past 2 weeks.
- For female subjects: 2 years postmenopausal or currently using effective contraception, and not lactating; negative urine pregnancy test within 24 hours of randomization.
- Weight of 40 to 90 kg and body mass index (BMI) of 18 to 32 during a 1-week period prior to treatment.
- Able to remain at facility allowing completion of pain and safety assessments for at least 8 hours after receiving study medication.
Who cannot join
- Has any significant medical disease other than malignancy that, in the Investigator's opinion, may interfere with study participation or completion of the study.
- Has a history of chronic analgesic or tranquilizer use (except for the subject's current pain medication [morphine, hydromorphone, and oxycodone, or an oxycodone/acetaminophen combination]) or known substance abuse within 90 days prior to the screening visit. Other drugs with analgesic properties, including nonsteroidal anti-inflammatory drugs, corticosteroids, tricyclic antidepressants, anticonvulsants, antiarrhythmics, bisphosphonates or gabapentinoids will not be initiated during the study. Patients receiving stable doses of these agents for pain management or other indications for >1 week prior to the screening visit may continue treatment with these provided that the dose remains constant during the study.
- Is unwilling to abstain from alcohol from at least 8 hours prior to dosing with study medication until time of discharge from the study unit.
- Has received or anticipates receiving any vitamin and mineral supplements from 24 hours prior to dosing until time of discharge from the study unit.
- Has received any investigational medication within 30 days prior to administration of study medication or is scheduled to receive an investigational drug other than study drug during the course of this study.
- Has clinically significant hypersensitivity to morphine, oxycodone, hydromorphone, other opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), or acetaminophen.
- Has a laboratory abnormality that, in the opinion of the Investigator, would contraindicate study participation, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), or blood urea nitrogen (BUN) levels greater than or equal to 1.5 times the upper limit of normal (ULN) or creatinine level greater than ULN at the screening evaluation.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Multi-Center, Pilot Study to Evaluate the Safety and Analgesic Activity of M40403 Co-Administered With an Opioid Agent in a Cancer Pain Model
M40403 was found to be effective in reducing pain in animal models and in clinical studies of subjects who were experiencing pain after dental surgery. The proposed study is designed to investigate the efficacy and safety of M40403 when co-administered with an opioid in subjects with pain due to cancer.
Read the detailed description
The proposed study is designed to investigate the efficacy, safety, and pharmacokinetics of M40403 in subjects with pain related to cancer. Because the effects of M40403 have not been previously investigated in subjects with cancer-related pain, the safety of single doses of 0.0625, 0.125, and 0.25 mg/kg of M40403 will be evaluated in an open label phase of the study. These doses of M40403 are similar to doses that were used in subjects who were experiencing pain in prior clinical studies with M40403.
- Being tested
- M40403
- Keywords
- cancer, pain, Cancers, Pain
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M40403Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and analgesic activity of a single dose of 0.25 mg/kg (or the highest tolerated dose from the open-label phase) of M40403 co-administered with current pain medication in subjects experiencing moderate to severe pain.
Secondary outcomes (1)
To evaluate safety and analgesic activity of ascending, single doses of M40403 (0.0625, 0.125, and 0.25mg/kg) co-administered with current pain medication and to assess the pharmacokinetic parameters of a single dose of M40403.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2005 (estimated)
- Study startAug 2004
- Study completionAug 2005
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- MetaPhore Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101621
- Sponsor's protocol ID
- U10-04-02-007
- Status last verified
- Feb 2006
- First submitted
- 12 Jan 2005
- Last updated
- 9 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Multi-Center, Pilot Study to Evaluate the Safety and Analgesic Activity of M40403 Co-Administered With an Opioid Agent in a Cancer Pain Model
- ClinicalTrials.gov ID
- NCT00101621
- Acronym / sponsor ID
- U10-04-02-007
- Keywords
- cancer, pain, Cancers, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 24 participants
- Lead sponsor
- MetaPhore PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Study completion
- Aug 2005
- First posted
- 13 Jan 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.
M40403 was found to be effective in reducing pain in animal models and in clinical studies of subjects who were experiencing pain after dental surgery. The proposed study is designed to investigate the efficacy and safety of M40403 when co-administered with an opioid in subjects with pain due to cancer.
Detailed description
The proposed study is designed to investigate the efficacy, safety, and pharmacokinetics of M40403 in subjects with pain related to cancer. Because the effects of M40403 have not been previously investigated in subjects with cancer-related pain, the safety of single doses of 0.0625, 0.125, and 0.25 mg/kg of M40403 will be evaluated in an open label phase of the study. These doses of M40403 are similar to doses that were used in subjects who were experiencing pain in prior clinical studies with M40403.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Has somatic or visceral pain due to solid tumor cancers (adrenal, basal cell, and breast cancers; transitional cell carcinoma of the bladder or uroepithelium; cholangiocarcinoma; small intestine/colon/rectal cancers; adenocarcinoma, esophageal/gastric cancers; hepatocellular, ovarian, pancreatic, and prostate cancers; bony/soft tissue sarcomas; small cell lung cancer; non small cell lung cancer; and adenocarcinomas of unknown primary origin).
- Has moderate to severe pain as measured by the Pain Intensity Assessment (categorical scale), and a pain intensity measurement of greater than or equal to 40 mm by visual analog scale (VAS) prior to the morning dose of pain medication.
- Stable chronic cancer pain as evidenced by a stable, scheduled opioid regimen over 7 days prior to treatment with study medication and fewer than 3 rescue doses per day averaged over the 3 days prior to treatment with study medication.
- Currently taking morphine, hydromorphone, oxycodone or an oxycodone/acetaminophen combination for the treatment of cancer pain.
- Age 18 or older.
Key exclusion criteria (7 listed)
- Has any significant medical disease other than malignancy that, in the Investigator's opinion, may interfere with study participation or completion of the study.
- Has a history of chronic analgesic or tranquilizer use (except for the subject's current pain medication [morphine, hydromorphone, and oxycodone, or an oxycodone/acetaminophen combination]) or known substance abuse within 90 days prior to the screening visit. Other drugs with analgesic properties, including nonsteroidal anti-inflammatory drugs, corticosteroids, tricyclic antidepressants, anticonvulsants, antiarrhythmics, bisphosphonates or gabapentinoids will not be initiated during the study. Patients receiving stable doses of these agents for pain management or other indications for >1 week prior to the screening visit may continue treatment with these provided that the dose remains constant during the study.
- Is unwilling to abstain from alcohol from at least 8 hours prior to dosing with study medication until time of discharge from the study unit.
- Has received or anticipates receiving any vitamin and mineral supplements from 24 hours prior to dosing until time of discharge from the study unit.
- Has received any investigational medication within 30 days prior to administration of study medication or is scheduled to receive an investigational drug other than study drug during the course of this study.
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 |
|---|---|---|
| M40403 | Drug | – |
Primary outcome
To evaluate the safety and analgesic activity of a single dose of 0.25 mg/kg (or the highest tolerated dose from the open-label phase) of M40403 co-administered with current pain medication in subjects experiencing moderate to severe pain.
1 secondary outcome
To evaluate safety and analgesic activity of ascending, single doses of M40403 (0.0625, 0.125, and 0.25mg/kg) co-administered with current pain medication and to assess the pharmacokinetic parameters of a single dose of M40403.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2006.
- Visit Metaphore Pharmaceuticals website to learn more about the company, its products and clinical trials.Link provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing M40403 in people with Cancer and Pain, run by MetaPhore Pharmaceuticals.
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 10 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: stopped early, as of the sponsor's last update on 9 Feb 2006. Status can change between updates, so confirm with the study contact before making plans.
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 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 was stopped early. Results are not available in the source record.
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?
To evaluate the safety and analgesic activity of a single dose of 0.25 mg/kg (or the highest tolerated dose from the open-label phase) of M40403 co-administered with current pain medication in subjects experiencing moderate to severe pain.. 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 9 Feb 2006.