- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01804530
Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors
August 1, 2018 updated by: Plexxikon
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Part 1. Open-label, sequential PLX7486 TsOH single-agent dose escalation in approximately 60 patients with solid tumors.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095
- Ronald Reagan UCLA Medical Center
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Maryland
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Baltimore, Maryland, United States, 21231
- John Hopkins Sidney Kimmel Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital Cancer Center
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- 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.
- 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
Exclusion Criteria
- 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%
- ≥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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PLX7486-TsOH, Dose escalation and RP2D
Part 1: Open-label, sequential PLX7486-TsOH single-agent dose escalation in approximately 60 patients with solid tumors.
|
PLX7486 TsOH capsules, 50mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of PLX7486 as single agent as measured by adverse events and serious adverse events.
Time Frame: 1 year
|
1 year
|
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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.
|
1 year
|
Peak concentration (Cmax)
Time Frame: 1 year
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Peak concentration (Cmax) will be used to assess the pharmacokinetic profile of PLX7486.
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1 year
|
Time to peak concentration (Tmax)
Time Frame: 1 year
|
Time to peak concentration (Tmax) will be used to assess the pharmacokinetic profile of PLX7486.
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1 year
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Half life (t1/2)
Time Frame: 1 year
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Half life (t1/2) will be used to assess the pharmacokinetic profile of PLX7486.
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1 year
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Terminal elimination rate constant (Kel)
Time Frame: 1 year
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Terminal elimination rate constant (Kel) will be used to assess the pharmacokinetic profile of PLX7486.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: 1 year
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1 year
|
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Duration of response (DOR)
Time Frame: 1 year
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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.
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1 year
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Progression-Free Survival (PFS)
Time Frame: 6 month
|
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.
|
6 month
|
Overall Response Rate (ORR)
Time Frame: 1year
|
1year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
January 24, 2018
Study Completion (Actual)
January 24, 2018
Study Registration Dates
First Submitted
March 1, 2013
First Submitted That Met QC Criteria
March 2, 2013
First Posted (Estimate)
March 5, 2013
Study Record Updates
Last Update Posted (Actual)
August 2, 2018
Last Update Submitted That Met QC Criteria
August 1, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLX119-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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