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Study of NK012 and Carboplatin in Solid Tumors With Dose Expansion in Triple Negative Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study of NK012 and Carboplatin in Solid Tumors With Dose Expansion in Triple Negative Breast Cancer

A Phase I Study of NK012 in Combination With Carboplatin in Patients With Advanced Solid Tumors Followed by a Dose Expansion Phase in Patients With Triple Negative Metastatic Breast Cancer

NCT01238952•Nippon Kayaku Co., Ltd.

View on ClinicalTrials.gov

Summary

The primary objective is to determine the maximum tolerated dose/recommended phase II dose of the combination regimen of NK012 and carboplatin in patients with advanced solid tumors.

Detailed Description

NK012 will be administered as a 30 minute IV infusion, followed by a 30 minute carboplatin IV infusion. Both drugs will be administered once every 28 days. Treatment is expected to continue for 6 cycles, unless disease progression or the development of unacceptable toxicity requires discontinuation of the drug. At the discretion of the investigator, patients who show signs of benefit may continue beyond 6 cycles. Once a MTD/RD has been determined, a dose expansion cohort of patients with metastatic triple negative breast cancer will be treated at the determined MTD.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically or cytologically confirmed diagnosis of advanced solid tumor for which no efficacious therapy exists, or for which a camptothecin-based regimen would be appropriate.
•2. For the dose expansion at the MTD/RD only:
•1. Patients must have triple-negative breast cancer with locally advanced disease for which there is no surgical option, or stage IV disease. Triple-negative breast cancer is defined as HER2-negative, ER-negative, and PR-negative as follows:
•For HER2- negative (must meet one of the following 3):
•( i) FISH negative (ratio \<2.2); or ( ii) IHC 0 or 1+; or (iii) IHC 2+ or 3+ and FISH negative (ratio \<2.2) For ER negative and PR negative: ≤ 10% tumor staining by IHC
•2. No less than one and no more than two prior chemotherapy regimens for advanced or metastatic breast cancer.
•3. Patients must have measurable disease by RECIST (version 1.1).
•3. Patients must have recovered from all acute adverse effects of prior therapies, excluding alopecia.
•4. For patients enrolled in the dose escalation phase, no more than 4 prior cytotoxic regimens in the metastatic setting.
•5. Prior irradiation to no more than 25% of the bone marrow.
+8 more criteria

Exclusion Criteria

•1. Prior chemotherapy, radiation therapy, or investigational therapy within 4 weeks (exception: 6 weeks for nitrosoureas or mitomycin C); or prior non-cytotoxic therapy within 5 drug half-lives (or 4 weeks, which ever is shorter); or monoclonal antibodies within 4 weeks prior to the first dose of study treatment.
•2. Concurrent use of another investigational agent.
•3. History of brain metastases or spinal cord compression, unless irradiated or treated a minimum of 4 weeks prior to first study treatment and stable without requirement of corticosteroids for \> 1 week.
•4. Concurrent serious infections requiring parenteral antibiotic therapy.
•5. Pregnant or of childbearing potential and not using methods to avoid pregnancy. A negative pregnancy test must be documented at baseline for women of child-bearing potential. Patients may not breast feed infants while on this study.
•6. Significant cardiac disease including heart failure that meets NYHA class III and IV definitions, history of myocardial infarction within 6 months of study entry, uncontrolled dysrhythmias or poorly controlled angina.
•7. History of serious ventricular arrhythmia (VT or VF, ≥ 3 beats in a row), QTc ≥ 450 msec for men and 470 msec for women, or LVEF ≤ 40% by MUGA or ECHO.
•8. History of allergic reactions attributed to compounds of topoisomerase I inhibitors, or platinum-containing compounds.
•9. Prior treatment with irinotecan.
•10. Prior treatment with more than 6 cycles of platinum drugs.

Locations (1)

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Key Dates

Start Date

July 1, 2010

Primary Completion Date

November 1, 2010

Completion Date

March 1, 2013

Last Updated

November 13, 2014

Enrollment

ACTUAL participants

Conditions

Advanced Solid TumorsMetastatic Triple Negative Breast Cancer

Interventions

NK012 and carboplatin

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of NK012 and Carboplatin in Solid Tumors With Dose Expansion in Triple Negative Breast Cancer

Inclusion Criteria

Exclusion Criteria

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