Solid TumorsPhase 1NCT02673736
A Study of PLX73086 in Advanced Solid Tumors and Locally Advanced or Refractory Tenosynovial Giant Cell Tumor
A Phase 1 study testing PLX73086 in people with Solid Tumors and Tenosynovial Giant Cell Tumor, run by Plexxikon at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Tenosynovial Giant Cell Tumor, Synovitis, Pigmented Villonodular
- What is being tested?
- PLX73086
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2016to Jan 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Symptomatic brain metastases.
- Investigational drug use within 14 days (or 5 half-lives, whichever is longer) of the first dose of PLX73086.
- Major surgical procedure, open biopsy (excluding skin cancer resection), or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed) or anticipation of the need for major surgery during the study.
- Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Medical Monitor. Examples of the latter include basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen. Subjects with a completely treated prior malignancy and no evidence of disease for ≥ 2 years are eligible.
- Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
- Baseline mean QTcF ≥ 450 msec (for males) or ≥ 470 msec (for females) at Screening.
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- Clinically significant cardiac arrhythmias including bradyarrhythmias and/or subjects who require anti-arrhythmic therapy (excluding beta blockers or digoxin). Subjects with controlled atrial fibrillation are not excluded
- Congenital long QT syndrome or subjects taking concomitant medications known to prolong the QT interval (e.g., tricyclics, azithromycin, methadone).
- History of clinically significant cardiac disease or congestive heart failure > New York Heart Association (NYHA) class 2. Subjects must not have unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months.
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication (except for adequately treated catheter-related venous thrombosis occurring more than 1 month before the start of study medication).
- Strong CYP3A4 inhibitors or inducers as well as inhibitors of breast cancer resistance protein (BCRP) within 14 days or 5 drug half-lives, whichever is longer, before start of study drug.
- Subjects with > Grade 1 (high or low) serum potassium, magnesium, or calcium levels.
- Women who are breast-feeding or pregnant.
- Non-healing wound, ulcer, or bone fracture.
- Known HIV-positive individuals on combination antiretroviral therapy.
- Subjects with known active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
- Uncontrolled intercurrent illness (i.e., active infection ≥ Grade 2) or concurrent condition that, in the opinion of the Investigator, would interfere with the study endpoints or the subject's ability to participate.
- The presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the subject inappropriate for inclusion in this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Karmanos Cancer Institute
Detroit, Michigan, 48201
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
HonorHealth
Scottsdale, Arizona, 85258
About this study
Official title: A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX73086 as a Single Agent in Subjects With Advanced Solid Tumors and in Subjects With Locally Advanced or Refractory Tenosynovial Giant Cell Tumor (TGCT)
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).
- Being tested
- PLX73086
- Keywords
- PLX73086, Synovitis, Pigmented Villonodular, Tenosynovial Giant Cell Tumor, Joint Diseases, Neoplasms, Synovitis
- Medical subject headings
- Giant Cell Tumor of Tendon Sheath, Synovitis, Pigmented Villonodular, Joint Diseases, Neoplasms, Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLX73086Drug
| Study group | Role | What they receive |
|---|---|---|
| PLX73086 | Experimental | Part 1: Open-label, sequential PLX73086 dose escalation in approximately 36 solid tumors subjects.
Part 2: Extension cohort at the recommended phase 2 dose (RP2D) of PLX73086 in approximately 30 subjects with histologically confirmed, unresectable, locally advanced or refractory TGCT (including metastatic disease). Receives: Drug: PLX73086 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of PLX73086, as measured by adverse events and serious adverse events [Part 1 and Part 2 of research study]
Measured: 1 year
Area under the concentration-time curve (AUC) of PLX73086 [Part 1 of research study]
Measured: 1 year
Maximum observed concentration (Cmax) of PLX73086 [Part 1 of research study]
Measured: 1 year
Time to peak concentration (Tmax) of PLX73086 [Part 1 of research study]
Measured: 1 year
Half life (t1/2) of PLX73086 [Part 1 of research study]
Measured: 1 year
Secondary outcomes (1)
Efficacy of PLX73086 measured by overall response rate (ORR) [Part 1 of research study]
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: Discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plexxikon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673736
- Sponsor's protocol ID
- PLX123-01
- Status last verified
- Aug 2018
- First submitted
- 29 Jan 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX73086 as a Single Agent in Subjects With Advanced Solid Tumors and in Subjects With Locally Advanced or Refractory Tenosynovial Giant Cell Tumor (TGCT)
- ClinicalTrials.gov ID
- NCT02673736
- Acronym / sponsor ID
- PLX123-01
- Keywords
- PLX73086, Synovitis, Pigmented Villonodular, Tenosynovial Giant Cell Tumor, Joint Diseases, Neoplasms, Synovitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinued
- Enrolment
- 11 participants (actual)
- Lead sponsor
- PlexxikonIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 4 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLX73086 | Experimental | Drug: PLX73086Part 1: Open-label, sequential PLX73086 dose escalation in approximately 36 solid tumors subjects. Part 2: Extension cohort at the recommended phase 2 dose (RP2D) of PLX73086 in approximately 30 subjects with histologically confirmed, unresectable, locally advanced or refractory TGCT (including metastatic disease). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- Symptomatic brain metastases.
- Investigational drug use within 14 days (or 5 half-lives, whichever is longer) of the first dose of PLX73086.
- Major surgical procedure, open biopsy (excluding skin cancer resection), or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed) or anticipation of the need for major surgery during the study.
- Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Medical Monitor. Examples of the latter include basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen. Subjects with a completely treated prior malignancy and no evidence of disease for ≥ 2 years are eligible.
- Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLX73086 | Drug | PLX73086 |
Primary outcome
Safety of PLX73086, as measured by adverse events and serious adverse events [Part 1 and Part 2 of research study]
Time frame: 1 year
Area under the concentration-time curve (AUC) of PLX73086 [Part 1 of research study]
Time frame: 1 year
Maximum observed concentration (Cmax) of PLX73086 [Part 1 of research study]
Time frame: 1 year
Time to peak concentration (Tmax) of PLX73086 [Part 1 of research study]
Time frame: 1 year
Half life (t1/2) of PLX73086 [Part 1 of research study]
Time frame: 1 year
1 secondary outcome
Efficacy of PLX73086 measured by overall response rate (ORR) [Part 1 of research study]
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Discontinued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PLX73086 in people with Solid Tumors and Tenosynovial Giant Cell Tumor, run by Plexxikon at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Discontinued). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of PLX73086, as measured by adverse events and serious adverse events [Part 1 and Part 2 of research study] (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.