Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors (NCT01804530) | Clinical Trial Compass
TerminatedPhase 1
Phase 1 Study of PLX7486 as Single Agent in Patients With Advanced Solid Tumors
Stopped: Discontinued
United States59 participantsStarted 2013-08
Plain-language summary
The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of PLX7486.
Who can participate
Age range18 Years
SexALL
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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 therap…
What they're measuring
1
Safety of PLX7486 as single agent as measured by adverse events and serious adverse events.
Timeframe: 1 year
2
Area under the plasma concentration-time curve [AUC0-t, AUC0-inf]