Status:
TERMINATED
Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors
Lead Sponsor:
Plexxikon
Conditions:
Solid Tumor
Tumors of Any Histology With Activating Trk (NTRK) Point or NTRK Fusion Mutations
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2018
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT01804530
Start Date
August 1 2013
End Date
January 24 2018
Last Update
August 2 2018
Active Locations (4)
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1
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
2
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
3
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29425