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Kinase Inhibitor
Targeted Therapy for Cancer (Strata PATH Trial)
Phase 2
Recruiting
Research Sponsored by Strata Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate cardiac function: 1) Left ventricular ejection fraction (LVEF) ≥ 50% and 2) QTc interval ≤ 470 ms (females) or ≤ 450 ms (males) average preferred
Biomarker positive for the defined cohort
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed throughout end of study, up to 5 years
Awards & highlights
Strata PATH Trial Summary
This trial is exploring how well different cancer therapies work in new patient populations that have been identified using biomarkers.
Who is the study for?
Adults with confirmed solid tumors who can provide blood samples and have specific biomarkers as per the trial's requirements. They must be able to follow the study schedule, have adequate organ function, and not be pregnant or nursing. Excluded are those on other cancer treatments, recent major surgery patients, individuals with primary brain tumors or uncontrolled medical conditions.Check my eligibility
What is being tested?
The Strata PATH™ trial is testing the effectiveness of various FDA-approved cancer drugs like encorafenib + binimetinib and pembrolizumab in new patient groups identified by certain biomarkers. It's an open-label study where all participants know which treatment they're receiving.See study design
What are the potential side effects?
Potential side effects include reactions typical for cancer therapies such as fatigue, nausea, skin reactions, changes in blood counts leading to increased infection risk or bleeding tendencies, potential heart issues (like altered heart rhythms), and possibly liver or kidney function changes.
Strata PATH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart is strong, with a good ejection fraction and normal QTc interval.
Select...
My condition matches the specific biomarker for this study.
Select...
My cancer is a solid tumor confirmed by a biopsy.
Strata PATH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed throughout end of study, up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed throughout end of study, up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR) defined as the percentage of participants with a best overall response of CR or PR based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by the investigator
Secondary outcome measures
Duration of Response (DoR) defined as the time from first documentation of disease response (CR or PR) until first documentation of progressive disease
Incidence of serious adverse events (SAEs)
Overall Survival (OS)
+4 moreOther outcome measures
Explore the correlation between serial ctDNA levels over time and participant response to cancer therapy based on RECIST 1.1, as assessed by the investigator.
Strata PATH Trial Design
5Treatment groups
Experimental Treatment
Group I: Trodelvy® (sacituzumab govitecan-hziy)Experimental Treatment1 Intervention
Group II: Talzenna® (talazoparib)Experimental Treatment1 Intervention
Group III: Lorbrena® (lorlatinib)Experimental Treatment1 Intervention
Group IV: Inlyta® (axitinib)Experimental Treatment1 Intervention
Group V: Braftovi® (encorafenib) + Mektovi® (binimetinib)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
FDA approved
axitinib
2016
Completed Phase 2
~2280
Lorlatinib
FDA approved
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,446 Total Patients Enrolled
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,326 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
847,779 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have side effects from cancer treatment, but not nerve damage, that are moderate to severe.My heart is strong, with a good ejection fraction and normal QTc interval.I have a brain tumor.I have not had major surgery in the last 4 weeks.I have not had cancer treatment in the last 3 weeks.My doctor says my organs and blood tests are good enough for treatment.My condition matches the specific biomarker for this study.I have a history of HIV or Hepatitis B/C.My brain metastases have been stable for at least 4 weeks.I am 18 years old or older.My cancer is a solid tumor confirmed by a biopsy.I do not have severe numbness or pain in my hands or feet.My cancer genetic test was done in a certified lab and I have the required tissue sample for further testing.I am not pregnant, nursing, or planning to become pregnant and will use contraception during treatment.I have not had a stroke, TIA, or heart attack in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Braftovi® (encorafenib) + Mektovi® (binimetinib)
- Group 2: Trodelvy® (sacituzumab govitecan-hziy)
- Group 3: Inlyta® (axitinib)
- Group 4: Talzenna® (talazoparib)
- Group 5: Lorbrena® (lorlatinib)
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
What maladies has this therapy been demonstrated to remedy?
"Metastatic melanoma is most successfully treated with this particular procedure. Additionally, it can be employed to address unresectable melanoma, malignant neoplasm and mammary tumours."
Answered by AI
Are there still spots available for participants in this research?
"Clinicaltrials.gov indicates that this medical investigation is recruiting participants at the time of writing. The study was first posted on November 19th 2021 and underwent its most recent update October 14th 2022."
Answered by AI
How many participants have been enrolled in the clinical trial thus far?
"Affirmative. According to clinicaltrials.gov, this research venture is still in the process of recruitment—which began on November 19th 2021 and was most recently updated October 14th 2022. 700 study participants are required for this trial at a single site location."
Answered by AI
Could you please point me to any other research projects concerning this therapy?
"Currently, 183 clinical trials are being conducted to explore the efficacy of this treatment. 24 of these studies have entered phase 3 and many of them originate in Phoenix, Arizona although there is a total of 11325 locations involved in running the experiments."
Answered by AI
Could this treatment cause adverse effects in patients?
"There is some evidence to support its safety, thus it scored a 2 on our scale. However, there are no studies that have tested the efficacy of this treatment yet."
Answered by AI
What goals is this research endeavor aiming to accomplish?
"According to the sponsor, Strata Oncology, this clinical trial's main objective is to measure ctDNA response over a period of up to 5 years. Secondary endpoints evaluated include Overall Survival (OS), Time To Treatment Discontinuation (TTD) and Duration Of Response (DoR)."
Answered by AI
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