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Oral TP-1454 for Cancer
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 50 months
Awards & highlights
Study Summary
This trial will test the safety of a new drug for people with cancer that has spread or gotten worse. The drug will be given alone and with other cancer drugs.
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.Check my eligibility
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.See study design
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 belowSelect...
I have an advanced cancer that hasn't responded to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 50 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~50 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine maximum tolerated dose (MTD)
Determine recommended Ph2 dose (RP2D) of TP-1454
Secondary outcome measures
Determine antitumor activity of TP-1454.
Determine incidence of dose-limiting toxicities (DLTs)
Trial Design
1Treatment groups
Experimental Treatment
Group I: TP-1454Experimental Treatment1 Intervention
Flat dose once or twice daily
Find a Location
Who is running the clinical trial?
Sumitomo Dainippon Pharma Oncology, IncLead Sponsor
41 Previous Clinical Trials
6,578 Total Patients Enrolled
Sumitomo Pharma America, Inc.Lead Sponsor
237 Previous Clinical Trials
52,682 Total Patients Enrolled
Sumitomo Pharma Oncology, Inc.Lead Sponsor
44 Previous Clinical Trials
6,899 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition or had surgery that affects how my body absorbs food.I have not had major surgery in the last 2 weeks.I have lung problems that make it hard for me to breathe.I have an advanced cancer that hasn't responded to treatment.I haven't had cancer treatment or experimental therapy in the last 28 days or 6 weeks for certain drugs.I have not had cancer, except for treatable in situ types, in the last 2 years.I have or had hepatitis B or C, but it's not active now.I am on medication for seizures.Your heart's electrical activity takes longer than normal to recharge after a beat.I have severe heart issues or had a heart attack in the last 6 months.I do not have any serious infections that need treatment with medication.Your oxygen level while resting is 90% or lower when breathing normal air.You have had allergic reactions to similar medicines or treatments in the past.I have brain metastases treated and am not on high-dose steroids.
Research Study Groups:
This trial has the following groups:- Group 1: TP-1454
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.
Does this study currently have open enrollment?
"According to clinicaltrials.gov, this particular study is not open for recruitment at the moment and has been edited for the final time on November 18th 2022. Nevertheless, 1433 other trials are still accepting participants."
Answered by AI
What are the potential adverse effects of TP-1454 monotherapy?
"There is limited clinical data establishing TP-1454 monotherapy's safety, thus it recieved a rating of 1."
Answered by AI
In what areas is the experiment being conducted?
"This trial has 9 locations that are currently running, including the Norris Cancer Center at University of Southern California and Hoag Memorial Hospital in Los Angeles, Texas Oncology Baylor Sammons Cancer Center in Dallas, Mayo Clinic Arizona in Phoenix, plus 6 other sites."
Answered by AI
Who else is applying?
What site did they apply to?
Comprehensive Cancer Center of Nevada
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I am hoping a trial may help. Chemo and Immunotherapy have not worked.
PatientReceived no prior treatments
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