What side effects are associated with this type of intervention?

The most common treatments for anal cancer, particularly those involving small molecule inhibitors like TP-1454, often result in side effects such as diarrhea, fatigue, nausea, and skin reactions. Additionally, standard treatments like chemoradiation can cause gastrointestinal issues, skin irritation, fatigue, and hematologic toxicities. These side effects are generally manageable but require careful monitoring and supportive care.

What prior FDA approvals exist?

The FDA has approved several treatments for anal cancer, primarily focusing on chemoradiation and targeted therapies. While there are no specific small molecule inhibitors currently approved exclusively for anal cancer, drugs like pembrolizumab (an immune checkpoint inhibitor) have shown efficacy in treating various cancers, including anal cancer. Investigational treatments like TP-1454, which target cancer progression pathways, represent a promising area of research, potentially expanding the therapeutic options for anal cancer in the future.

What other types of research exist?

Promising alternatives to TP-1454 for anal cancer patients include LY3023414, a PI3K/mTOR dual inhibitor, and PF299804, a pan-HER inhibitor. Both have shown potential in early-phase clinical trials for advanced malignancies. Additionally, immune checkpoint inhibitors like pembrolizumab and nivolumab are being actively investigated and have shown efficacy in various cancers, including those with similar progression pathways.

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Oral TP-1454 for 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

Patients to be enrolled during Dose Escalation with capsules must have a histologically confirmed diagnosis of advanced metastatic or progressive solid tumor who are refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition (enrollment complete).

Be older than 18 years old

Must not have

Have malabsorption conditions or have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption

Have undergone major surgery within 2 weeks prior to Cycle 1/Day 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 50 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new oral drug called TP-1454 in patients with advanced metastatic or progressive solid tumors and anal cancer. The study aims to find the best dose and see how the drug moves through the body. Researchers will also check if TP-1454 can help shrink tumors.

Who is the study for?

This trial is for adults with advanced metastatic or progressive solid tumors, including anal cancer. Participants must have had prior platinum-based therapy if they have anal cancer and no more than three systemic treatments. They should be in good physical condition (ECOG ≤1), not pregnant, and willing to use contraception. HIV+ patients can join under certain conditions.

What is being tested?

The study tests the safety of TP-1454 as a solo treatment when taken orally by people with severe forms of cancer that have spread. It's in Phase 1, which means it's early in testing and focuses on finding the right dose without causing harm.

What are the potential side effects?

While specific side effects are not listed here, common ones for oral cancer drugs include nausea, fatigue, diarrhea, mouth sores, loss of appetite and changes in taste. Since this is a Phase 1 trial focused on safety, monitoring for any adverse reactions will be a primary concern.

Eligibility Criteria

Inclusion Criteria

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

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I have an advanced cancer that hasn't responded to treatment.

Exclusion Criteria

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

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I have a condition or had surgery that affects how my body absorbs food.

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

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I have lung problems that make it hard for me to breathe.

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I haven't had cancer treatment or experimental therapy in the last 28 days or 6 weeks for certain drugs.

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I have not had cancer, except for treatable in situ types, in the last 2 years.

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I am on medication for seizures.

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I have severe heart issues or had a heart attack in the last 6 months.

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I do not have any serious infections that need treatment with medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 50 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~50 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 50 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

Determine maximum tolerated dose (MTD)

Determine recommended Ph2 dose (RP2D) of TP-1454

Secondary study objectives

Determine antitumor activity of TP-1454.

Determine incidence of dose-limiting toxicities (DLTs)

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: TP-1454Experimental Treatment1 Intervention

Flat dose once or twice daily

0 / 9Eligibility 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

The most common treatments for anal cancer include chemotherapy, radiation therapy, and targeted therapies. Chemotherapy works by using drugs to kill rapidly dividing cancer cells, while radiation therapy uses high-energy rays to destroy cancer cells. Targeted therapies, such as small molecule inhibitors like TP-1454, focus on specific molecular pathways that are crucial for cancer cell growth and survival. These treatments are significant for anal cancer patients as they offer a more precise approach, potentially reducing side effects and improving outcomes by directly targeting cancer progression mechanisms.

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