Solid TumorPhase 1NCT01804530
Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors
A Phase 1 study testing PLX7486 TsOH in people with Solid Tumor and Tumors of Any Histology With Activating Trk (NTRK) Point or NTRK Fusion Mutations, run by Plexxikon at 4 sites in United States.
Trial summary
The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of PLX7486. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Tumors of Any Histology With Activating Trk (NTRK) Point or NTRK Fusion Mutations, Tenosynovial Giant Cell Tumor
- What is being tested?
- PLX7486 TsOH
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2013to 24 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
- Male or female ≥18 years old
- Patients with histologically confirmed solid tumors who:
- o Part 1: have tumor progression following standard therapy, have treatment-refractory disease, or for whom there is no effective standard of therapy
- Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. 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
- Patients with stable, treated brain metastases are eligible for this trial. However, patients must not have required steroid treatment for their brain metastases within 30 days of Screening.
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- Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements
- Karnofsky performance status ≥70%
- Life expectancy ≥3 months
- Adequate hematologic, hepatic, and renal function
Who cannot join
- Other than the primary malignancy, active cancer (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g., chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in situ, or carcinoma in-situ of the cervix
- Chemotherapy within 28 days prior to C1D1
- Biological therapy within 5 half-lives prior to C1D1
- Radiation therapy within 28 days or 5 half-lives prior to C1D1, whichever is longer
- Investigational drug use within 28 days or 5 half-lives, whichever is longer, prior to C1D1
- Part 1 only: (a) Patients with active or a history of glucose intolerance or diabetes mellitus and (b) Hemoglobin A1c ≥7%
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- ≥Grade 2 sensory neuropathy at baseline
- Uncontrolled intercurrent illness (i.e., active infection) or concurrent condition that, in the opinion of the Investigator, would interfere with the study endpoints or the patient's ability to participate
- Refractory nausea and vomiting, malabsorption, small bowel resection that, in the opinion of the Investigator, would preclude adequate absorption
- Mean QTcF ≥450 msec (for males) or ≥470 msec (for females) at Screening
- The presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the patient inappropriate for inclusion in this study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
About this study
Official title: A Phase 1 Study to Assess Safety, Pharmacokinetics, and Pharmacodynamics of PLX7486 as a Single Agent in Patients With Advanced Solid Tumors
The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of PLX7486.
Read the detailed description
Part 1. Open-label, sequential PLX7486 TsOH single-agent dose escalation in approximately 60 patients with solid tumors.
- Conditions
- Solid Tumor, Tumors of Any Histology With Activating Trk (NTRK) Point or NTRK Fusion Mutations, Tenosynovial Giant Cell Tumor
- Being tested
- PLX7486 TsOH
- Keywords
- solid tumors, activating NTRK point or fusion mutations, Tenosynovial giant cell tumor, TGCT
- Medical subject headings
- Giant Cell Tumor of Tendon Sheath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLX7486 TsOHDrug
PLX7486 TsOH capsules, 50mg
| Study group | Role | What they receive |
|---|---|---|
| PLX7486-TsOH, Dose escalation and RP2D | Experimental | Part 1: Open-label, sequential PLX7486-TsOH single-agent dose escalation in approximately 60 patients with solid tumors. Receives: Drug: PLX7486 TsOH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of PLX7486 as single agent as measured by adverse events and serious adverse events.
Measured: 1 year
Area under the plasma concentration-time curve [AUC0-t, AUC0-inf]
Area under the plasma concentration-time curve [AUC0-t, AUC0-inf] will be used to assess the pharmacokinetic profile of PLX7486.
Measured: 1 year
Peak concentration (Cmax)
Peak concentration (Cmax) will be used to assess the pharmacokinetic profile of PLX7486.
Measured: 1 year
Time to peak concentration (Tmax)
Time to peak concentration (Tmax) will be used to assess the pharmacokinetic profile of PLX7486.
Measured: 1 year
Half life (t1/2)
Half life (t1/2) will be used to assess the pharmacokinetic profile of PLX7486.
Measured: 1 year
Terminal elimination rate constant (Kel)
Terminal elimination rate constant (Kel) will be used to assess the pharmacokinetic profile of PLX7486.
Measured: 1 year
Secondary outcomes (4)
Duration of response (DOR)
Duration of response is defined as the number of days from the date of initial response (PR or better) to the date of first documented disease progression/relapse or death, whichever occurs first.
Measured: 1 year
Progression-Free Survival (PFS)
Progression-free survival (PFS) is defined as the number of days from start of therapy to the date of documented disease progression/relapse, whichever occurs first.
Measured: 6 month
Overall Response Rate (ORR)
Measured: 1year
Overall Survival (OS)
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 posted5 Mar 2013 (estimated)
- Study startAug 2013
- Primary completion24 Jan 2018
- Study completion24 Jan 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 TumorStudies 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plexxikon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804530
- Sponsor's protocol ID
- PLX119-01
- Status last verified
- Aug 2018
- First submitted
- 1 Mar 2013
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
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 PLX7486 as a Single Agent in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01804530
- Acronym / sponsor ID
- PLX119-01
- Conditions
- Solid Tumor, Tumors of Any Histology With Activating Trk (NTRK) Point or NTRK Fusion Mutations, Tenosynovial Giant Cell Tumor
- Keywords
- solid tumors, activating NTRK point or fusion mutations, Tenosynovial giant cell tumor, TGCT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinued
- Enrolment
- 59 participants (actual)
- Lead sponsor
- PlexxikonIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 5 Mar 2013 (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 objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of PLX7486.
Detailed description
Part 1. Open-label, sequential PLX7486 TsOH single-agent dose escalation in approximately 60 patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PLX7486-TsOH, Dose escalation and RP2D | Experimental | Drug: PLX7486 TsOHPart 1: Open-label, sequential PLX7486-TsOH single-agent dose escalation in approximately 60 patients with solid tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female ≥18 years old
- Patients with histologically confirmed solid tumors who:
- o Part 1: have tumor progression following standard therapy, have treatment-refractory disease, or for whom there is no effective standard of therapy
- Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. 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
Key exclusion criteria (11 listed)
- Other than the primary malignancy, active cancer (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g., chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in situ, or carcinoma in-situ of the cervix
- Chemotherapy within 28 days prior to C1D1
- Biological therapy within 5 half-lives prior to C1D1
- Radiation therapy within 28 days or 5 half-lives prior to C1D1, whichever is longer
- Investigational drug use within 28 days or 5 half-lives, whichever is longer, prior to C1D1
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 |
|---|---|---|
| PLX7486 TsOHPLX7486 TsOH capsules, 50mg | Drug | PLX7486-TsOH, Dose escalation and RP2D |
Primary outcome
Safety of PLX7486 as single agent as measured by adverse events and serious adverse events.
Time frame: 1 year
Area under the plasma concentration-time curve [AUC0-t, AUC0-inf]
Time frame: 1 year
Area under the plasma concentration-time curve [AUC0-t, AUC0-inf] will be used to assess the pharmacokinetic profile of PLX7486.
Peak concentration (Cmax)
Time frame: 1 year
Peak concentration (Cmax) will be used to assess the pharmacokinetic profile of PLX7486.
Time to peak concentration (Tmax)
Time frame: 1 year
Time to peak concentration (Tmax) will be used to assess the pharmacokinetic profile of PLX7486.
Half life (t1/2)
Time frame: 1 year
Half life (t1/2) will be used to assess the pharmacokinetic profile of PLX7486.
Terminal elimination rate constant (Kel)
Time frame: 1 year
Terminal elimination rate constant (Kel) will be used to assess the pharmacokinetic profile of PLX7486.
4 secondary outcomes
Duration of response (DOR)
Time frame: 1 year
Progression-Free Survival (PFS)
Time frame: 6 month
Overall Response Rate (ORR)
Time frame: 1year
Overall Survival (OS)
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.
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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.
4 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 PLX7486 TsOH in people with Solid Tumor and Tumors of Any Histology With Activating Trk (NTRK) Point or NTRK Fusion Mutations, run by Plexxikon at 4 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 11 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 4 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 PLX7486 as single agent as measured by adverse events and serious adverse events. (time frame: 1 year). The study lists 6 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.