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Camsirubicin for Soft Tissue Sarcoma
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).
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have had brain metastasis but have been treated, stable, and symptom-free for over 60 days.I have had radiation therapy to my chest or heart area or whole pelvis, but other chest treatments are okay.I am 18 years old or older.I agree to use effective birth control during and up to 3 months after the study.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant and cannot become pregnant due to surgery or menopause.I have never been treated with anthracyclines.I do not have any uncontrolled infections like HIV or hepatitis.I do not have any health conditions that would make it unsafe for me to participate.I am not breastfeeding or will stop before starting the treatment and won't breastfeed for 3 months after the last dose.My cancer is a type of advanced sarcoma that cannot be removed by surgery or cured with radiation.I have not had a heart attack or any heart procedures in the last 6 months.I have been diagnosed with a specific type of sarcoma.I have serious heart issues, including heart failure or irregular heartbeat.I am not pregnant or breastfeeding.I haven't had chemotherapy for advanced sarcoma and can receive anthracycline.I haven't had cancer in the last 5 years, except for certain skin, cervical, or superficial bladder cancers.I have been treated with specific chemotherapy drugs before.
- Group 1: Camsirubicin + pegfilgrastim
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many participants are involved in this experiment?
"Affirmative. Clinicaltrials.gov has documented that recruitment for this experiment, which was first uploaded on September 22nd 2021, is currently ongoing. 21 participants must be found from a single location to complete the trial's requirements."
What are the typical applications of Camsirubicin?
"Camsirubicin is an effective way to combat chemotherapy induced neutropenia, as well as concomitant myelosuppressive chemotherapy, malignant neoplasms, and accompanying infection."
Are there any vacancies available for this clinical exploration?
"Evidently, this clinical trial is recruiting participants as revealed on clinicaltrials.gov. It was posted to the website in September 2021 and revised last November 2022."
Has the Federal Drug Administration certified Camsirubicin for utilization?
"Due to the limited evidence of both efficacy and safety, Camsirubicin was given a score of 1 out of 3."
Could you provide a synopsis of past experiments involving Camsirubicin?
"Presently, 38 clinical investigations into Camsirubicin are in progress with 11 Phase 3 trials ongoing. Of these studies, the majority of them originate from Princeton, Illinois while an additional 2366 sites across the globe have been running tests as well."
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