This is a Phase I dose-escalation study of the intravenous administration of NK012 in patients with refractory solid tumors. Patients will receive NK012 as an intravenous infusion over 30 minutes on Day 1 followed by a 20-day observation period for a total of 21 days (3 weeks) per cycle. Two patient populations will be evaluated separately: patients with UGT1A1\*28 genotype homozygous wild type (wt/wt) and heterozygous (wt/\*28) variants as one group, and patients with UGT1A1\*28 homozygous variant (\*28/\*28) as another group. Dose-escalation in each patient population will proceed according to the predefined dose level.

For UGT1A1\*28 (wt/wt and wt/\*28) patients, at least 3 evaluable patients will be treated at each dose level.

UGT1A1 homozygous (\*28/\*28) patients will be treated at 50% of the current dose level.

Patients will receive up to 6 cycles of NK012, unless they experience unacceptable toxicity or disease progression, requiring withdrawal from the study.

9.0, 12.0, 16.0, 21.0, 28.0 mg/m\^2, and to be determined. Intravenous infusion

NK012

Howard A. Burris, III, MD

The purpose of this study is to determine whether NK012 is safe and effective in the treatment of refractory solid tumors

This is a Phase I dose-escalation study of the intravenous administration of NK012 in patients with refractory solid tumors. Patients will receive NK012 as an intravenous infusion over 30 minutes on Day 1 followed by a 20-day observation period for a total of 21 days (3 weeks) per cycle. Two patient populations will be evaluated separately: patients with UGT1A1\*28 genotype homozygous wild type (wt/wt) and heterozygous (wt/\*28) variants as one group, and patients with UGT1A1\*28 homozygous variant (\*28/\*28) as another group.

Study of NK012 in Patients With Refractory Solid Tumors

A Phase I Dose-escalation Study of NK012 Administered Intravenously as a Single Dose Every Three Weeks in Patients With Refractory Solid Tumors

After MTD was determined, the administration schedule was changed to every 28 days per cycle, considering patient safety.

Overall response will be evaluated every 2 cycles

Nippon Kayaku Co., Ltd.

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

30 minute IV infusion once every 28 days. NK012 dose is 28 mg/m\^2 (or 18 mg/m\^2 depending on UGT1A1 polymorphism, with potential to dose escalate). Dose escalation cannot exceed 28 mg/m\^2. Dosing will proceed until progression or unacceptable toxicity develops, or decision by patient or investigator to stop.

Denise A Yardley, MD

The purpose of this study is to determine whether NK012 is safe and effective in the treatment of advanced and metastatic triple negative breast cancer.

This is a Phase II, open label, single arm, multicenter study of NK012 in patients with locally advanced non-resectable and metastatic breast cancer with ER-negative, PR negative and HER2-negative phenotype. NK012 will be administered by infusion over 30 minutes once every 28 days (on Day 1 of each cycle). Patients will be screened for UGT1A1 polymorphism prior to enrollment in order to determine their starting dose.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of NK012 in Patients With Refractory Solid Tumors	NCT00542958	Cancer	NK012	18 Years -	Nippon Kayaku Co., Ltd.
A Study of NK012 in Patients With Advanced, Metastatic Triple Negative Breast Cancer	NCT00951054	Triple Negative...	NK012	18 Years -	Nippon Kayaku Co., Ltd.

Spots Global Cancer Trial Database for nk012

Every month we try and update this database with for nk012 cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for nk012

Every month we try and update this database with for nk012 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 nk012 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.