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A Study of PLX73086 in Advanced Solid Tumors and Locally Advanced or Refractory Tenosynovial Giant Cell Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02673736
Recruitment Status : Terminated (Discontinued)
First Posted : February 4, 2016
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Plexxikon

Brief 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).

Condition or disease Intervention/treatment Phase
Solid Tumors Tenosynovial Giant Cell Tumor Synovitis, Pigmented Villonodular Drug: PLX73086 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : February 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PLX73086

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).

Drug: PLX73086



Primary Outcome Measures :
  1. Safety of PLX73086, as measured by adverse events and serious adverse events [Part 1 and Part 2 of research study] [ Time Frame: 1 year ]
  2. Area under the concentration-time curve (AUC) of PLX73086 [Part 1 of research study] [ Time Frame: 1 year ]
  3. Maximum observed concentration (Cmax) of PLX73086 [Part 1 of research study] [ Time Frame: 1 year ]
  4. Time to peak concentration (Tmax) of PLX73086 [Part 1 of research study] [ Time Frame: 1 year ]
  5. Half life (t1/2) of PLX73086 [Part 1 of research study] [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Efficacy of PLX73086 measured by overall response rate (ORR) [Part 1 of research study] [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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-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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673736


Locations
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United States, Arizona
HonorHealth
Scottsdale, Arizona, United States, 85258
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Plexxikon
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Responsible Party: Plexxikon
ClinicalTrials.gov Identifier: NCT02673736    
Other Study ID Numbers: PLX123-01
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Plexxikon:
PLX73086
Synovitis, Pigmented Villonodular
Tenosynovial Giant Cell Tumor
Joint Diseases
Neoplasms
Synovitis
Additional relevant MeSH terms:
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Giant Cell Tumors
Giant Cell Tumor of Tendon Sheath
Synovitis, Pigmented Villonodular
Synovitis
Neoplasms
Joint Diseases
Musculoskeletal Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Tendinopathy
Muscular Diseases