Neuropathic PainPhase 2NCT00474916
Neuropathic Pain in Patients With Cancer
A Phase 2 study testing KRN5500 in people with Neuropathic Pain, run by DARA Therapeutics at 12 sites in 2 countries.
Trial summary
The purpose of this study is to collect beginning information on whether intravenous (IV) administration of KRN5500 is safe and effective for treatment of neuropathic pain in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- KRN5500
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Jun 2006to Apr 2009
- 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
- 18 years or older
- Diagnosis of advanced or recurrent cancer
- No options for curative chemotherapy, but palliative chemotherapy allowed under certain conditions
- Refractory neuropathic pain rated 4 or greater on 0-10 scale and failure to respond to 2 commonly used treatments
- If taking opioids for pain, stable regimen over past week before enrolling
- Karnofsky performance status of 40 or more
- Females must be sterile or post-menopausal
Who cannot join
- Radiation to site of neuropathic pain for past 4 weeks
- Major surgery within past 2 weeks
- Liver function and other key labs outside normal parameters
- ECG showing significant abnormality
- Myocardial Infarction (heart attack) within past 6 months
- History of interstitial lung disease
- History of severe allergic reaction to drugs containing polysorbate 80
- Other investigational drug within 2 weeks or 5 half-lives (whichever is longer
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
St. Agnes Healthcare, Inc
Baltimore, Maryland, 21229
Massachusetts General Hospital
Boston, Massachusetts, 02114
Hematology and Oncology Specialists, LLC
Covington, Louisiana, 70433
Duke University Medical Center
Durham, North Carolina, 27710
East Orange VA Medical Center
East Orange, New Jersey, 07018
Keog Pharma, Inc.
Jupiter, Florida, 33477
Cancer Institute Medical Group
Los Angeles, California, 90025
Ghassan Al-Jazayrly, M.D., Inc.
Los Angeles, California, 90027
University of California / Irvine Chao Family Comprehensive Cancer Center
Orange, California, 92868
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Carolina Pain Institute, PA
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer
The purpose of this study is to collect beginning information on whether intravenous (IV) administration of KRN5500 is safe and effective for treatment of neuropathic pain in patients with cancer.
Read the detailed description
Neuropathic pain is a type of pain that results from nerve damage and is characterized by an abnormal hypersensitivity to harmless as well as harmful stimuli. This type of pain is extremely difficult to manage, fails to respond to standard analgesic medications or interventions, and often gets worse instead of better over time. Current approved therapeutic agents often have intolerable side effects and limited efficacy. Thus, there is an urgent need to develop safe and effective drugs to treat neuropathic pain.
Study DTCL100 will be conducted at multiple centers and will enroll patients that have advanced cancer AND neuropathic pain that has not responded well to previous treatment. Eighteen patients will be randomly assigned to receive up to 8 doses of active drug (KRN5500) or placebo. A maximum of 8 doses will be administered weekly over a 10 week period. Patients are encouraged to complete at least 4 treatment visits before a decision is made to complete the full 10 weeks of treatment and the 1 month followup period.
- Conditions
- Neuropathic Pain
- Being tested
- KRN5500, Placebo
- Keywords
- Neuropathic pain, Cancer
- Medical subject headings
- Neuralgia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KRN5500Drug
Patients are seen weekly and dosed for pain with IV medication of active drug/KRN5500 or placebo . The dose can be escalated, from .6 mg/m2, to 1.2, 1.8, and 2.2 mg/m2.
PlaceboDrug
Normal Saline given as dose escalation for placebo
| Study group | Role | What they receive |
|---|---|---|
| KRN5500 | Experimental | KRN5500 escalating dose of .6, 1.2, 1.8, or 2.2 mg/m2 in IV infusion of normal saline Receives: Drug: KRN5500 |
| Normal Saline | Placebo comparator | Placebo consists of IV infusion of normal saline Receives: Drug: KRN5500; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain intensity over the previous 24 hours as measured by a numeric rating scale (NRS) ranging from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain."
Measured: Weekly for 10 weeks plus 30 day followup
Secondary outcomes (1)
Physical Examination, Vital signs and body weight, Electrocardiogram, Laboratory parameters, Adverse events, Clinical Opiate Withdrawal Scale, rescue medication, Proportion of patients who achieved a 33% reduction in pain intensity
Measured: Weekly for 10 weeks plus 30 day followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startJun 2006
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- DARA Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Penson, MD, MRCP, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474916
- Sponsor's protocol ID
- DTCL100
- Status last verified
- Aug 2010
- First submitted
- 15 May 2007
- Last updated
- 16 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer
- ClinicalTrials.gov ID
- NCT00474916
- Acronym / sponsor ID
- DTCL100
- Conditions
- Neuropathic Pain
- Keywords
- Neuropathic pain, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- DARA TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 17 May 2007 (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.
The purpose of this study is to collect beginning information on whether intravenous (IV) administration of KRN5500 is safe and effective for treatment of neuropathic pain in patients with cancer.
Detailed description
Neuropathic pain is a type of pain that results from nerve damage and is characterized by an abnormal hypersensitivity to harmless as well as harmful stimuli. This type of pain is extremely difficult to manage, fails to respond to standard analgesic medications or interventions, and often gets worse instead of better over time. Current approved therapeutic agents often have intolerable side effects and limited efficacy. Thus, there is an urgent need to develop safe and effective drugs to treat neuropathic pain.
Study DTCL100 will be conducted at multiple centers and will enroll patients that have advanced cancer AND neuropathic pain that has not responded well to previous treatment. Eighteen patients will be randomly assigned to receive up to 8 doses of active drug (KRN5500) or placebo. A maximum of 8 doses will be administered weekly over a 10 week period. Patients are encouraged to complete at least 4 treatment visits before a decision is made to complete the full 10 weeks of treatment and the 1 month followup period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KRN5500 | Experimental | Drug: KRN5500KRN5500 escalating dose of .6, 1.2, 1.8, or 2.2 mg/m2 in IV infusion of normal saline |
| Normal Saline | Placebo comparator | Drug: KRN5500, Drug: PlaceboPlacebo consists of IV infusion of normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- Diagnosis of advanced or recurrent cancer
- No options for curative chemotherapy, but palliative chemotherapy allowed under certain conditions
- Refractory neuropathic pain rated 4 or greater on 0-10 scale and failure to respond to 2 commonly used treatments
- If taking opioids for pain, stable regimen over past week before enrolling
Key exclusion criteria (8 listed)
- Radiation to site of neuropathic pain for past 4 weeks
- Major surgery within past 2 weeks
- Liver function and other key labs outside normal parameters
- ECG showing significant abnormality
- Myocardial Infarction (heart attack) within past 6 months
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 |
|---|---|---|
| KRN5500Patients are seen weekly and dosed for pain with IV medication of active drug/KRN5500 or placebo . The dose can be escalated, from .6 mg/m2, to 1.2, 1.8, and 2.2 mg/m2. | Drug | KRN5500, Normal Saline |
| PlaceboNormal Saline given as dose escalation for placebo | Drug | Normal Saline |
Primary outcome
Average pain intensity over the previous 24 hours as measured by a numeric rating scale (NRS) ranging from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain."
Time frame: Weekly for 10 weeks plus 30 day followup
1 secondary outcome
Physical Examination, Vital signs and body weight, Electrocardiogram, Laboratory parameters, Adverse events, Clinical Opiate Withdrawal Scale, rescue medication, Proportion of patients who achieved a 33% reduction in pain intensity
Time frame: Weekly for 10 weeks plus 30 day followup
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 16 Aug 2010.
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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.
Richard Penson, MD, MRCP principal investigator
Massachusetts General Hospital
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KRN5500 in people with Neuropathic Pain, run by DARA Therapeutics at 12 sites in 2 countries.
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 7 inclusion and 8 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 16 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. 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 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?
Average pain intensity over the previous 24 hours as measured by a numeric rating scale (NRS) ranging from 0 to 10 where 0 represents "no pain" and 10 represents the "worst possible pain." (time frame: Weekly for 10 weeks plus 30 day followup). 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 16 Aug 2010.