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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 weeks
Treatment ~ Varies
Follow Up ~through study completion, average 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average 1 year for reporting.

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 more

Trial 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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma
2017. "Dose-Escalation and Expansion Trial of NC-6300 in Patients With Advanced Solid Tumors or Soft Tissue Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03168061.
All > Soft Tissue Sarcoma
~19 spots leftby Apr 2025
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