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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 23 months
Awards & highlights
Study Summary
This trial is testing a new drug, TP-1287, to see if it is safe and effective for treating patients with advanced cancer who have not responded to other treatments.
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.Check my eligibility
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).See study design
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 belowSelect...
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).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 23 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~23 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single Arm TP-1287Experimental Treatment1 Intervention
TP-1287 by oral administration
Find a Location
Who is running the clinical trial?
Sumitomo Dainippon Pharma Oncology, IncLead Sponsor
41 Previous Clinical Trials
6,554 Total Patients Enrolled
1 Trials studying Sarcoma
24 Patients Enrolled for Sarcoma
Sumitomo Pharma America, Inc.Lead Sponsor
236 Previous Clinical Trials
52,646 Total Patients Enrolled
1 Trials studying Sarcoma
24 Patients Enrolled for Sarcoma
Sumitomo Pharma Oncology, Inc.Lead Sponsor
44 Previous Clinical Trials
6,875 Total Patients Enrolled
1 Trials studying Sarcoma
24 Patients Enrolled for Sarcoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older, or I am 12 or older with Ewing sarcoma and weigh at least 40 kg.I have an advanced solid tumor, but it's not a rapidly spreading type or one with extensive liver involvement.I have at least one tumor that can be measured for treatment response.I am mostly active and can carry out light work.I am willing and able to follow the study's required procedures.My condition hasn't improved with standard treatments.I have brain metastases but they are treated and under control.I have an advanced solid tumor, but it's not one that grows very quickly.I have Ewing sarcoma that cannot be removed by surgery.I've had 1-5 treatments before, including one with an anthracycline.I have severe COPD with low oxygen levels.My liver functions are within the normal range, even if I have liver metastases.My kidneys work well enough (creatinine clearance ≥ 30 mL/min).I have signed the consent form and, if under legal age, also provided assent.I've had 1-3 treatments for my condition, including one with an anthracycline.I have at least one tumor that can be measured.I do not have severe heart issues or recent heart attacks.I do not have a serious illness that could interfere with the study.I have or had HIV, hepatitis B, or C, but my hepatitis is not currently active.My liver functions within normal limits, or any bilirubin increase is due to Gilbert's syndrome.I haven't had cancer treatment or surgery in the last 28 days or 6 weeks for certain drugs.I have not had major surgery in the last 2 weeks.I do not have any active infections needing strong medication.I have a condition like Crohn's or had major gut surgery that affects how I absorb food.I am on medication for seizures.My heart's electrical activity, measured by QTcF, is within a safe range.My condition hasn't improved with standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm TP-1287
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.
Has the FDA sanctioned TP-1287 for therapeutic use?
"TP-1287's safety is only minimally supported by clinical data, so it has been assigned a score of 1."
Answered by AI
Are researchers currently recruiting participants for this trial?
"This clinical trial is currently seeking enrollees. The listing was initially put up on December 26th 2018 and revised most recently on November 18th 2022, according to information published at clinicialtrials.gov."
Answered by AI
In what geographic locations is this inquiry being carried out?
"This clinical trial is supported by 8 sites across the United States, including Dana Farber Cancer Institute in Boston ma, Fox Chase Cancer Centre in Philadelphia pa and University of Miami Sylvester Comprehensive Cancer Center in Florida."
Answered by AI
To what extent has participation in this trial extended?
"This clinical study requires 80 eligible patients to volunteer in order to be completed. Two of the sites offering this trial are Dana Farber Cancer Institute and Fox Chase Cancer Center, both located on opposite sides of the country in Boston and Philadelphia respectively."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
USC Norris Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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