Camsirubicin for advanced Soft Tissue Sarcoma (STS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
advanced Soft Tissue Sarcoma (STS)+1 More
Camsirubicin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug, camsirubicin, to see if it is safe and effective in treating advanced soft tissue sarcomas. The primary endpoint is to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of camsirubicin. Secondary endpoints include safety, progression-free survival (PFS), time to progression (TTP), overall response rate (ORR), duration of response (DoR), overall survival (OS), and pharmacokinetics (PK).

Eligible Conditions
  • advanced Soft Tissue Sarcoma (STS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 3 weeks after first injection

Week 3
To determine Maximum Tolerated Dose (MTD)
Year 1
Incidence of Treatment-Emergent Adverse Events [Safety]
Recommended Phase 2 Dose (RP2D) Camsirubicin HCl for Injection

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Camsirubicin + pegfilgrastim
1 of 1

Experimental Treatment

21 Total Participants · 1 Treatment Group

Primary Treatment: Camsirubicin · No Placebo Group · Phase 1

Camsirubicin + pegfilgrastim
Drug
Experimental Group · 1 Intervention: Camsirubicin · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 weeks after first injection

Who is running the clinical trial?

Monopar TherapeuticsLead Sponsor
1 Previous Clinical Trials
260 Total Patients Enrolled
Holli CarlsonStudy DirectorMonopar Therapeutics Inc.

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.
You have a performance status of 0-1 on the ECOG scale.
You have an absolute neutrophil count (ANC) of 1,500 or more per cubic millimeter.
You must provide informed consent prior to performance of study-specific procedures and must be willing to comply with treatment and follow-up

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: November 4th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.