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Polymer-drug conjugate
NC-6300 for Sarcoma
Phase 1 & 2
Waitlist Available
Research Sponsored by NanoCarrier Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, average 1 year
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see what the highest safe dose is, and how well it is tolerated.
Eligible Conditions
- Sarcoma
- Solid Tumors
- Soft Tissue Sarcoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, average 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, average 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MTD dose of NC-6300
RPII dose of NC-6300
Secondary outcome measures
Change in quality of life as measured by EORTC QLQ-C30
Safety as measured by incidence and severity of TEAEs and laboratory anomalies
Other outcome measures
AUC
CL
Ceoi
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: NC-6300Experimental Treatment1 Intervention
In Part 1, patients will receive an intravenous infusion of NC-6300 at escalating doses starting at a fixed dose on Day 1 of a 21-day cycle. After enrollment of the initial patient, the first patient in each cohort will not be enrolled until all patients at the immediately lower cohort have completed at least 1 full 21-day cycle. In Part 1, patients will continue to receive treatment until they experience disease progression, experience unacceptable toxicity, or withdraw voluntarily.
Part 2 will begin after the RPII dose of NC-6300 is identified. All patients in Part 2 will receive NC-6300 at the RPII dose.
Find a Location
Who is running the clinical trial?
NanoCarrier Co., Ltd.Lead Sponsor
7 Previous Clinical Trials
734 Total Patients Enrolled
Atsushi OsadaStudy DirectorNanoCarrier Co., Ltd.
1 Previous Clinical Trials
136 Total Patients Enrolled
Frequently Asked Questions
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