Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors
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ClinicalTrials.gov Identifier: NCT01804530 |
Recruitment Status :
Terminated
(Discontinued)
First Posted : March 5, 2013
Last Update Posted : August 2, 2018
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Condition or disease | Intervention/treatment | Phase |
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Solid Tumor Tumors of Any Histology With Activating Trk (NTRK) Point or NTRK Fusion Mutations Tenosynovial Giant Cell Tumor | Drug: PLX7486 TsOH | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 59 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 PLX7486 as a Single Agent in Patients With Advanced Solid Tumors |
Study Start Date : | August 2013 |
Actual Primary Completion Date : | January 24, 2018 |
Actual Study Completion Date : | January 24, 2018 |

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.
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Drug: PLX7486 TsOH
PLX7486 TsOH capsules, 50mg |
- 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.
- Duration of response (DOR) [ Time Frame: 1 year ]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.
- 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.
- Overall Response Rate (ORR) [ Time Frame: 1year ]
- Overall Survival (OS) [ Time Frame: 1 year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Male or female ≥18 years old
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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

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): NCT01804530
United States, California | |
Ronald Reagan UCLA Medical Center | |
Los Angeles, California, United States, 90095 | |
United States, Maryland | |
John Hopkins Sidney Kimmel Comprehensive Cancer Center | |
Baltimore, Maryland, United States, 21231 | |
United States, Massachusetts | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Responsible Party: | Plexxikon |
ClinicalTrials.gov Identifier: | NCT01804530 |
Other Study ID Numbers: |
PLX119-01 |
First Posted: | March 5, 2013 Key Record Dates |
Last Update Posted: | August 2, 2018 |
Last Verified: | August 2018 |
solid tumors activating NTRK point or fusion mutations Tenosynovial giant cell tumor TGCT |
Neoplasms Giant Cell Tumors Giant Cell Tumor of Tendon Sheath Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type |
Synovitis Joint Diseases Musculoskeletal Diseases Tendinopathy Muscular Diseases |