Safety Study of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

This was a 3-part study designed to explore the safety and tolerability of escalating doses of PLX3397 with weekly paclitaxel to establish a recommended Phase 2 dose (RP2D), to confirm RP2D in participants with advanced non-resectable solid tumors, and to determine the efficacy of PLX3397 600 mg twice daily (BID) administered in combination with weekly paclitaxel in participants with advanced, metastatic or non-resectable, platinum-resistant or -refractory epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Key facts

Study ID

NCT01525602

Run by

Daiichi Sankyo

People needed

74

Starts

2012-05-01

Expected to finish

2018-02-01

Last updated by the study team

2020-07-16

Who can join

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

You may qualify if…

• Patients with:
• Part 1 (enrollment closed): an advanced, incurable solid tumor
• Part 2 (enrollment closed): an advanced, incurable solid tumor for whom a taxane would be considered a reasonable chemotherapy option
• Part 3 (enrollment closed): advanced, metastatic or non-resectable epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer with
• platinum-resistant cancer, defined as disease that responded to a platinum-containing chemotherapy regimen, but demonstrated recurrence within six months following the completion of that platinum-containing regimen, OR
• platinum-refractory cancer, defined as disease failed to achieve at least a partial response to a platinum-containing regimen (i.e., stable disease or actual disease progression), AND
• have not been treated with a taxane within six months of Cycle 1 Day 1 (C1D1), AND
• have not been treated with weekly paclitaxel after first-line treatment in which weekly paclitaxel plus a platinum is permitted
• Part 3: Patients must have target (≥2 cm diameter) or non-target lesion cancer that is accessible for core biopsies before starting on study and after one cycle of treatment.
• Patients with stable brain metastases are eligible for this trial. However, patients must not have required steroid treatment for their brain metastases within 30 days of Screening.
• Bone-directed therapy (e.g., bisphosphonates or denosumab) is permitted.
• Washout from any prior investigational therapy of at least five times the T1/2 prior to C1D1
• Washout from any prior biologic or targeted therapy at least 4 weeks or five times the plasma half-life (T1/2) (whichever is shorter) prior to C1D1
• Washout from prior chemotherapy of at least 2 weeks or 1 elimination half-life, whichever is longer, prior to C1D1
• Washout from prior hormonal therapy of at least 2 weeks prior to C1D1
• Washout of at least 2 weeks from the most recent radiation treatment prior to C1D1
• Resolution of all prior treatment-related toxicities to Grade 1 or less, except for Grade 2 fatigue or alopecia prior to C1D1
• Age eighteen years or older
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2, inclusive
• Anticipated life expectancy of at least 12 weeks
• Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥1500/mm3, platelets ≥100,000/mm3
• Adequate renal function: serum creatinine <1.5 x ULN or calculated creatinine clearance (CrCl) >60 mL/min using Cockcroft-Gault formula
• Adequate hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 x upper limit of normal (ULN), Total and Direct Bilirubin <1.5 x ULN. However, in the presence of liver metastases, AST and ALT must be <5 x ULN
• Cardiac ejection fraction ≥50%, and QT interval corrected by Fridericia's formula (QTcF) <450 ms (males) or <470 ms (females) on electrocardiogram (ECG) at Baseline.
• Able to swallow capsules and maintain adequate hydration

You may not qualify if…

• Presence of an active secondary malignancy.
• Patients with a non-melanomatous, in situ malignancy or disease that is completely resectable with surgery may be considered after discussion with the Medical Monitor
• Patients with a completely treated prior malignancy with no evidence of disease for ≥3 years are eligible
• Refractory nausea and vomiting, malabsorption, external biliary shunt or significant small bowel resection that would preclude adequate absorption of PLX3397
• Ongoing treatment with any other investigational therapy
• Prior anaphylactic or severe hypersensitivity reaction to paclitaxel or Cremophor-containing agent.
• Persistent grade 2 fatigue at Baseline.
• Severe, concurrent illness including congestive heart failure, significant cardiac disease and uncontrolled hypertension, that would likely prevent the patient from being able to comply with the study protocol
• Active untreated infection
• Known chronic active Hepatitis B or C, or HIV infection
• 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

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Univeristy of California, San Francisco — San Francisco, California, United States
• University of Colorado, Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Sylvester Comprehensive Cancer Center/UMHC — Miami, Florida, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University of Utah, Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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