What is the mechanism of action of this treatment?

The most common treatments for Liposarcoma include chemotherapy agents like doxorubicin and ifosfamide, as well as targeted therapies such as selective enzyme blockers. Doxorubicin works by intercalating DNA, thereby inhibiting the replication of cancer cells, while ifosfamide alkylates DNA, leading to cell death. Selective enzyme blockers, like the one studied in the SPH4336 trial, inhibit specific enzymes crucial for tumor growth and survival. These treatments are vital for Liposarcoma patients as they target the cancer cells' ability to proliferate and survive, potentially leading to better outcomes and prolonged survival.

What side effects are associated with this type of intervention?

In the study of SPH4336, a selective enzyme blocker for liposarcoma, the focus was on evaluating safety and preliminary anti-tumor effects. While specific side effects for SPH4336 were not detailed, common side effects for similar treatments often include gastrointestinal issues such as diarrhea, skin reactions like rash, and fatigue. Other potential side effects may include nausea, alopecia, and hyperglycemia, as observed in treatments involving enzyme inhibitors and chemotherapy agents.

What prior FDA approvals exist?

The FDA has approved several treatments for liposarcoma, particularly focusing on targeted therapies. One notable approval is for the CDK4/6 inhibitor, palbociclib, which targets cell cycle regulation. Additionally, pazopanib, a tyrosine kinase inhibitor, has been approved for advanced soft tissue sarcomas, including liposarcoma, due to its anti-angiogenic properties. These treatments align with the mechanism of action being studied in the SPH4336 trial, which also involves selective enzyme inhibition.

What other types of research exist?

Promising alternatives to SPH4336 for liposarcoma patients include: 1) S49076, a MET/AXL/FGFR inhibitor, which has shown a tolerable safety profile and encouraging pharmacodynamic readouts in advanced solid tumors. 2) The combination of sapanisertib (TAK-228) and serabelisib (TAK-117) with paclitaxel, which demonstrated a 47% overall response rate and 73% clinical benefit rate in heavily pretreated patients with advanced solid tumors.

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CDK4/6 Inhibitor

CDK4/6 Inhibitor for Liposarcoma

Phase 2

Waitlist Available

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

No Placebo-Only Group

Summary

This trial tests SPH4336, a chemotherapy pill, in patients with CDK4-positive liposarcomas. The drug works by blocking an enzyme that cancer cells need to grow, aiming to stop tumor growth.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS) at 12 weeks

Secondary study objectives

Best Overall Response

Duration of Response

Incidence and severity of adverse events

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SPH4336Experimental Treatment1 Intervention

400 mg (2 - 200 mg tablets) PO QD

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Liposarcoma include chemotherapy agents like doxorubicin and ifosfamide, as well as targeted therapies such as selective enzyme blockers. Doxorubicin works by intercalating DNA, thereby inhibiting the replication of cancer cells, while ifosfamide alkylates DNA, leading to cell death. Selective enzyme blockers, like the one studied in the SPH4336 trial, inhibit specific enzymes crucial for tumor growth and survival. These treatments are vital for Liposarcoma patients as they target the cancer cells' ability to proliferate and survive, potentially leading to better outcomes and prolonged survival.

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