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CDK4/6 Inhibitor
CDK4/6 Inhibitor for Liposarcoma
Phase 2
Recruiting
Research Sponsored by Shanghai Pharma Biotherapeutics USA Inc.
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 from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Awards & highlights
Study Summary
This trial tests the safety and anti-tumor effects of a drug to treat liposarcomas, a type of tumor.
Who is the study for?
Adults over 18 with advanced liposarcomas, either dedifferentiated or well-differentiated/dedifferentiated, who have had no more than three prior treatments and show tumor progression. Participants must be in good physical condition (ECOG 0 or 1), not have major organ dysfunction, agree to use effective contraception, and provide tissue samples for research.Check my eligibility
What is being tested?
The trial is testing SPH4336, a selective enzyme blocker designed to treat specific types of liposarcomas. It's an open-label study meaning everyone gets the drug; there's no placebo group. The focus is on safety, how the body processes the drug (pharmacokinetics), and its initial effectiveness against tumors.See study design
What are the potential side effects?
While specific side effects of SPH4336 are not listed here, common ones for drugs like CDK4/6 inhibitors include fatigue, low blood cell counts leading to increased infection risk or bleeding problems, nausea or vomiting, hair loss and possible liver issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS) at 12 weeks
Secondary outcome measures
Best Overall Response
Duration of Response
Incidence and severity of adverse events
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: SPH4336Experimental Treatment1 Intervention
400 mg (2 - 200 mg tablets) PO QD
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Who is running the clinical trial?
Shanghai Pharma Biotherapeutics USA Inc.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Kenneth W Locke, PhDStudy DirectorShanghai Pharma Biotherapeutics USA Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My sarcoma is confirmed and has spread or is advanced.I have been treated with a CDK4/6 inhibitor before.I currently have COVID-19.I am fully active or can carry out light work.I have had 3 or fewer previous cancer treatments.I have not had major surgery in the last 4 weeks.I haven't had cancer treatment in the last 14 days or 5 half-lives, whichever is longer.I am 18 years old or older.I am not pregnant or nursing.I am not on strong medication that affects liver enzymes at study entry.My brain metastases are treated and stable for 28 days without steroids.My tumor does not have CDK4.I haven't had serious heart issues like uncontrolled chest pain or heart attacks in the last 6 months.My cancer has grown or spread in the last 3 months.My condition is a type of liposarcoma.I have hepatitis B or C with a detectable viral load.I do not have any severe infections.I have been cancer-free for over 2 years from another type of cancer.I do not have stomach or bowel problems that could affect medication absorption.My previous treatment side effects are mild, my blood counts and kidney function are within safe ranges, and I can use or am using effective contraception.
Research Study Groups:
This trial has the following groups:- Group 1: SPH4336
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the margin of safety for SPH4336?
"There is some data suggesting that SPH4336 is safe, but none to support efficacy. Therefore, it received a score of 2."
Answered by AI
Is it possible to sign up for this research project at this time?
"This particular clinical trial, which was first made public on December 1st, 2020, is not currently looking for new candidates. Although this specific study isn't searching for participants right now, there are 46 other trials with open recruitment at this time."
Answered by AI
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