Nervous System Diseases

Symptoms and General Pathology

All Conditions

Neuralgia

Pain

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neurologic Manifestations

Antineoplastic Agents

All Drugs and Chemicals

KRN 5500

Enzyme Inhibitors

KRN5500 escalating dose of .6, 1.2, 1.8, or 2.2 mg/m2 in IV infusion of 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.

KRN5500

Normal Saline given as dose escalation for placebo

Placebo

Richard Penson, MD, MRCP

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.

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.

Neuropathic Pain in Patients With Cancer

A Phase 2 Double-Blind Dose Escalation Study of KRN5500 for Neuropathic Pain in Patients With Cancer

DARA Therapeutics

Linda Jett, MSN, Clinical Director

Patricia M. LoRusso, DO

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to evaluate the effectiveness of KRN5500 in treating patients with metastatic solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose and toxicities of KRN5500 in patients with solid malignant tumors. II. Characterize the clinical pharmacokinetics of KRN5500 in this patient population. III. Initiate the preliminary evaluation of antitumor activity of KRN5500 in these patients. IV. Determine the recommended Phase II dose of KRN5500.

OUTLINE: This is a dose escalation study. Patients receive KRN5500 IV over 1 hour on days 1-3. Courses repeat every 21 days. Patients with stable disease and partial or complete remission continue treatment for 6 months beyond complete remission. Cohorts of 3 to 6 patients receive escalating doses of KRN5500. The maximum tolerated dose is defined as the dose preceding that at which at least 2 of 6 patients experience dose limiting toxicity.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study over 9-12 months.

KRN5500 in Treating Patients With Metastatic Solid Tumors

Phase I Evaluation of KRN5500 (NSC650426)

National Cancer Institute (NCI)

Barbara Ann Karmanos Cancer Institute

Principal Investigator

Patients receive KRN5500 IV over 24-72 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-3 patients receive KRN5500 at the starting dose over escalating infusion durations. After the longest duration of infusion time is safely reached, cohorts of 3-6 patients receive escalating doses of KRN5500 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with KRN5500 at the recommended phase II dose.

pharmacological study

Joseph Eder

Phase I trial to study the effectiveness of KRN5500 in treating patients who have solid tumors. Drugs used in chemotherapy, such as KRN5500, work in different ways to stop cancer cells from dividing so they stop growing or die

PRIMARY OBJECTIVES:

I. To establish the MTD and identify the DLTs of the investigational agent KRN5500 when administered by a 72-hr continuous i.v. infusion to patients with solid tumors who have failed standard therapy or for whom no standard therapy exists.

II. To establish and assess the safety of an appropriate dose for phase II studies.

III. To characterize the pharmacokinetics of KRN5500 in patients when administered by a 72 hr continuous IV infusion.

IV. To characterize the response to KRN5500 by FLT-PET scanning at the MTD.

SECONDARY OBJECTIVES:

I. To describe any preliminary evidence of antitumor activity. II. Establish pharmacodynamic relationships for the pharmacological effect of the drug upon surrogate markers of activity and host toxicity.

III. To compare the toxicity profiles for the 1 hr i.v. infusion and 72 hr continuous i.v. infusion administration schedules.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive KRN5500 IV over 24-72 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-3 patients receive KRN5500 at the starting dose over escalating infusion durations. After the longest duration of infusion time is safely reached, cohorts of 3-6 patients receive escalating doses of KRN5500 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with KRN5500 at the recommended phase II dose.

Patients are followed every 4 weeks until resolution of all toxicity.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 9-12 months.

KRN5500 in Treating Patients With Solid Tumors

A Phase I Trial of KRN5500 (NSC 650426) Given as a 72 Hour Continuous IV Infusion Every 21 Days in Patients With Solid Tumors

Analyzed by noncompartmental methods and/or nonlinear least squares regression using WinNonlin (Scientific Consulting, Inc.).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neuropathic Pain in Patients With Cancer	NCT00474916	Neuropathic Pai...	KRN5500 Placebo	18 Years -	DARA Therapeutics
KRN5500 in Treating Patients With Metastatic Solid Tumors	NCT00002923	Unspecified Adu...	KRN5500	15 Years -	Barbara Ann Karmanos Cancer Institute
KRN5500 in Treating Patients With Solid Tumors	NCT00017238	Unspecified Adu...	KRN5500 pharmacological...	18 Years -	National Cancer Institute (NCI)
KRN5500 in Treating Patients With Solid Tumors	NCT00017238	Unspecified Adu...	KRN5500 pharmacological...	18 Years -	National Cancer Institute (NCI)
Neuropathic Pain in Patients With Cancer	NCT00474916	Neuropathic Pai...	KRN5500 Placebo	18 Years -	DARA Therapeutics
KRN5500 in Treating Patients With Metastatic Solid Tumors	NCT00002923	Unspecified Adu...	KRN5500	15 Years -	Barbara Ann Karmanos Cancer Institute
KRN5500 in Treating Patients With Solid Tumors	NCT00017238	Unspecified Adu...	KRN5500 pharmacological...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for krn5500

Every month we try and update this database with for krn5500 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for krn5500

Every month we try and update this database with for krn5500 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for krn5500 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.