Clinical Study of KW-2246 in Patients With Cancer Pain

This study is a Phase II open-label study to investigate, using the continual reassessment method procedure by pain intensity and safety as indicators, the recommended conversion ratio (oral morphine dose to KW-2246) when switching oral morphine or oxycodone to KW-2246 in cancer patients who have been maintained on oral morphine or oral oxycodone for pain and to evaluate the safety and efficacy of KW-2246.

Inclusion criteria

• Provide written informed consent to participate in the study.
• Be able to be hospitalized.
• Between the ages of 20 and 80 years (inclusive) at the time of giving written informed consent.
• Have regularly received oral morphine or oral oxycodone at an oral morphine equivalent dose of 20 to 120 mg/day for at least 2 days before study entry, AND not have required any rescue dose between regular doses.
• Not have experienced intolerable toxicity for 2 days before study entry.
• Have cancer that is in stable condition at study entry and expected to remain stable during the KW-2246 treatment period.
• Have a life expectancy of at least 1 month after the start of KW-2246 administration.
• Considered to be able to keep the patient diary.

Exclusion criteria

• Serious respiratory dysfunction.
• Asthma.
• Serious bradyarrhythmia.
• Serious hepatic or renal dysfunction.
• Susceptibility to respiratory depression due to such conditions as increased intracranial pressure, head injury and brain tumor.
• History of convulsive seizures (except a single episode of infantile febrile convulsions).
• Current or past history of drug dependence or narcotic abuse.
• Dry mouth that affects oral intake.
• Use of opioid analgesics other than oral morphine or oxycodone within 7 days prior to study entry.
• Use of narcotic antagonists within 7 days prior to study entry.
• Interventions that may affect pain evaluation, such as surgery, radiation to the pain site (including those sites that influence pain) and nerve block, within 7 days prior to study entry or scheduled to be given during the study.
• Patients with a history of serious adverse reactions to the combination of opioid analgesics and other drugs/substances who are currently receiving or expected to receive those drugs/substances combined to opioid analgesics.
• History of hypersensitivity to fentanyl.
• Pregnant or lactating women, possibly pregnant women or women who are planning to become pregnant.
• Participation in any other clinical trial within 28 days prior to the start of KW-2246 treatment.
• Prior exposure to KW-2246.
• Patients whom an investigator judge unsuitable for enrollment.