Neuropathic Pain in Patients With Cancer
13. august 2010 opdateret af: DARA Therapeutics
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
19
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Los Angeles, California, Forenede Stater, 90025
- Cancer Institute Medical Group
-
Los Angeles, California, Forenede Stater, 90027
- Ghassan Al-Jazayrly, M.D., Inc.
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Orange, California, Forenede Stater, 92868
- University of California / Irvine Chao Family Comprehensive Cancer Center
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-
Florida
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Jupiter, Florida, Forenede Stater, 33477
- Keog Pharma, Inc.
-
-
Louisiana
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Covington, Louisiana, Forenede Stater, 70433
- Hematology And Oncology Specialists, Llc
-
-
Maryland
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Baltimore, Maryland, Forenede Stater, 21229
- St. Agnes Healthcare, Inc
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
-
-
New Jersey
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East Orange, New Jersey, Forenede Stater, 07018
- East Orange VA Medical Center
-
-
North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Carolina Pain Institute, PA
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Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute
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-
-
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Rio Piedras, Puerto Rico, 00921
- Dr. Rivera-Colon
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: KRN5500
KRN5500 escalating dose of .6,
1.2, 1.8, or 2.2 mg/m2 in IV infusion of normal saline
|
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.
|
|
Placebo komparator: Normal Saline
Placebo consists of IV infusion of normal saline
|
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.
Normal Saline given as dose escalation for placebo
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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."
Tidsramme: Weekly for 10 weeks plus 30 day followup
|
Weekly for 10 weeks plus 30 day followup
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
Tidsramme: Weekly for 10 weeks plus 30 day followup
|
Weekly for 10 weeks plus 30 day followup
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Richard Penson, MD, MRCP, Massachusetts General Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2006
Primær færdiggørelse (Faktiske)
1. marts 2009
Studieafslutning (Faktiske)
1. april 2009
Datoer for studieregistrering
Først indsendt
15. maj 2007
Først indsendt, der opfyldte QC-kriterier
15. maj 2007
Først opslået (Skøn)
17. maj 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. august 2010
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
13. august 2010
Sidst verificeret
1. august 2010
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DTCL100
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .