A Study of PLX73086 in Advanced Solid Tumors and Locally Advanced or Refractory Tenosynovial Gian… (NCT02673736) | Clinical Trial Compass
TerminatedPhase 1
A Study of PLX73086 in Advanced Solid Tumors and Locally Advanced or Refractory Tenosynovial Giant Cell Tumor
Stopped: Discontinued
United States11 participantsStarted 2016-02
Plain-language summary
The purpose of this research study is to evaluate safety, pharmacokinetics and preliminary efficacy of the investigational drug PLX73086 in subjects with solid tumors including subjects with locally advanced or refractory tenosynovial giant cell tumor (TGCT).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years old.
* Part 1: Subjects with solid tumors that are refractory to, relapsed after or intolerant to standard therapy, or for whom no standard therapy exists or who are considered by the investigator to be inappropriate for standard therapy.
* Part 2: Subjects with histologically confirmed, locally advanced or refractory TGCT (including metastatic disease) that has been deemed unresectable by an orthopedic surgeon or similar qualified personnel.
* Measurable disease by RECIST 1.1 criteria.
* Women of child-bearing potential must have a negative pregnancy test within 7 days prior to initiation of dosing and must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 3 months after the last dose of study drug, Fertile men must also agree to use an acceptable method of birth control while on study drug and up to 3 months after the last dose of study drug.
* All associated toxicity from previous or concurrent cancer therapy must be resolved (to ≤ Grade 1 or Baseline) prior to study treatment administration.
* Willingness and ability to provide written informed consent prior to any study-related procedures and comply with all study requirements.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
* Life expectancy ≥ 3 months.
* Adequate hematologic, hepatic, and renal function.
Exclusion Criteria:
* Symptomatic brain metastases.
* Investigational drug use within 14 days (or 5 half-l…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of PLX73086, as measured by adverse events and serious adverse events [Part 1 and Part 2 of research study]
Timeframe: 1 year
2
Area under the concentration-time curve (AUC) of PLX73086 [Part 1 of research study]
Timeframe: 1 year
3
Maximum observed concentration (Cmax) of PLX73086 [Part 1 of research study]
Timeframe: 1 year
4
Time to peak concentration (Tmax) of PLX73086 [Part 1 of research study]
Timeframe: 1 year
5
Half life (t1/2) of PLX73086 [Part 1 of research study]