Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Solid Tumor, Tumors of Any Histology With Activating Trk (NTRK) Point or NTRK Fusion Mutations, Tenosynovial Giant Cell Tumor

In brief

The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of PLX7486.

Key facts

Study ID

NCT01804530

Run by

Plexxikon

People needed

59

Starts

2013-08-01

Expected to finish

2018-01-24

Last updated by the study team

2018-08-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• John Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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