What side effects are associated with this type of intervention?

Common treatments for sarcoma, particularly those involving CDK inhibitors like TP-1287, often result in side effects such as neutropenia, anemia, fatigue, nausea, and diarrhea. Broader sarcoma treatments, including chemotherapy and targeted therapies, typically cause cytopenias, gastrointestinal issues, fatigue, and skin reactions.

What prior FDA approvals exist?

FDA-approved treatments for sarcoma include a variety of chemotherapeutic agents, targeted therapies, and immunotherapies. Commonly used chemotherapeutic agents include doxorubicin and ifosfamide. Targeted therapies such as pazopanib, an oral tyrosine kinase inhibitor, have also been approved for advanced soft tissue sarcoma. Immunotherapy options include pembrolizumab for certain subtypes with high microsatellite instability. While CDK4/6 inhibitors like palbociclib have shown some promise in liposarcoma, there are no specific FDA approvals for CDK9 inhibitors in sarcoma treatment as of now.

What other types of research exist?

Promising novel alternatives to TP-1287 for sarcoma patients include CDK4/6 inhibitors, such as abemaciclib, which have shown efficacy in various cancers. Additionally, PI3K/AKT/mTOR inhibitors like everolimus and temsirolimus are being investigated for their potential in treating sarcomas. These agents target key pathways involved in cell growth and survival, offering potential therapeutic benefits.

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CDK9 inhibitor

TP-1287 for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by Sumitomo Dainippon Pharma Oncology, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Dose Expansion: Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1

For Dose Escalation: Patients with a histologically confirmed diagnosis of advanced metastatic or progressive solid tumor excluding tumor types with rapid cell turnover

Must not have

Patients with severe chronic obstructive pulmonary disease with hypoxemia (defined as resting 02 saturation of less than or equal to 90% breathing room air)

Patients with a history of congestive heart failure (CHF) greater than New York Heart Association (NYHA) Class III, myocardial infarction within the past 6 months prior to Cycle 1 Day 1, left ventricular ejection fraction (LVEF) less than 45% by echocardiogram (ECHO) or multigated acquisition scan (MUGA), uncontrolled unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG) within 14 days prior to Cycle 1 Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 23 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests TP-1287, an oral medicine that blocks a protein needed by cancer cells to grow. It targets patients with advanced cancers who do not respond to standard treatments. The goal is to find the best dose and see if it helps control the cancer.

Who is the study for?

This trial is for adults with advanced solid tumors who've had 1-3 prior treatments including an anthracycline, are not responding to standard therapy, and have a life expectancy of at least 3 months. Ewing sarcoma patients over 12 years old weighing more than 40 kg can also join. Participants must have acceptable organ function and agree to use contraception.

What is being tested?

TP-1287, an oral drug designed to inhibit CDK9, is being tested in this Phase 1 study. The goal is to find the highest dose patients can take without serious side effects (MTD) by gradually increasing doses among small groups of participants (dose escalation), then giving this dose to more people (dose expansion).

What are the potential side effects?

Potential side effects include those common with cancer drugs targeting cell division such as fatigue, nausea, diarrhea, low blood counts leading to increased infection risk or bleeding problems. Specific side effects related to TP-1287 will be monitored closely due to its experimental nature.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly active and can carry out light work.

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I have an advanced solid tumor, but it's not one that grows very quickly.

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I have Ewing sarcoma that cannot be removed by surgery.

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My liver functions are within the normal range, even if I have liver metastases.

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My kidneys work well enough (creatinine clearance ≥ 30 mL/min).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe COPD with low oxygen levels.

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I do not have severe heart issues or recent heart attacks.

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I have not had major surgery in the last 2 weeks.

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I do not have any active infections needing strong medication.

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I have a condition like Crohn's or had major gut surgery that affects how I absorb food.

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I am on medication for seizures.

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My heart's electrical activity, measured by QTcF, is within a safe range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 23 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~23 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 23 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

During Dose Escalation: Determine maximum tolerated dose (MTD)

During Dose Escalation: Incidence of dose-limiting toxicities (DLTs) and treatment emergent adverse events

During Dose Expansion: Determine preliminary antitumor activity of TP-1287 in terms of clinical benefit rate (CBR) at week 16 when administered at the RP2D in patients with sarcoma.

+1 more

Secondary study objectives

During Dose Escalation: Determine antitumor activity of TP-1287

During Dose Escalation: Recommended Phase 2 Dose of TP-1287

During Dose Expansion: Determine the median progression-free survival (PFS) rate in patients with sarcoma

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: Single Arm TP-1287Experimental Treatment1 Intervention

TP-1287 by oral administration

0 / 12Eligibility criteria met

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

Common treatments for sarcoma include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy agents like doxorubicin work by damaging the DNA of cancer cells, leading to cell death. Targeted therapies, such as tyrosine kinase inhibitors (e.g., pazopanib) and mTOR inhibitors (e.g., temsirolimus), interfere with specific molecular pathways crucial for tumor growth and survival. CDK inhibitors, like the investigational CDK9 inhibitor TP-1287, block cyclin-dependent kinases involved in cell cycle regulation, potentially halting tumor proliferation. These treatments are vital for sarcoma patients due to the complex and aggressive nature of these tumors, often requiring a multifaceted approach to improve outcomes.

Stress Granules in the Anti-Cancer Medications Mechanism of Action: A Systematic Scoping Review.Fifty years of advances in sarcoma treatment: moving the needle from conventional chemotherapy to targeted therapy.