Phase I Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of BVD-523 in Patients With Advanced Malignancies
Completed · Phase 1/Phase 2
Conditions studied: Advanced Solid Tumors
In brief
This open-label, multi-center Phase 1/2 study will assess the safety, pharmacokinetics, and pharmacodynamics of escalating doses of BVD-523 in patients with advanced malignancies. The study also seeks to demonstrate target modulation and early signs of clinical response in select patient populations.
Key facts
- Study ID
- NCT01781429
- Run by
- BioMed Valley Discoveries, Inc
- People needed
- 136
- Starts
- 2013-03-01
- Expected to finish
- 2018-09-01
- Last updated by the study team
- 2020-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with metastatic or advanced-stage malignant tumor. Patients may have received up to 2 prior lines of chemotherapy for their metastatic disease
- ECOG score of 0 or 1
- Predicted life expectancy of ≥ 3 months
- Adequate bone marrow, liver and renal function renal function
- Adequate cardiac function
- For women: Negative pregnancy test for females of child-bearing potential; must be surgically sterile, postmenopausal, or compliant with a contraceptive regimen during and for 3 months after the treatment period
- For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for 3 months after the treatment period
- For Part 2 of the Study only, patients must have measurable disease by RECIST 1.1 and be in one of the the groups below. Patients in groups 1, 2, 4, 5 and 6 may not have been previously treated with BRAF and/or MEK inhibitors
- Group 1: Patients with BRAF mutated cancer, except those with colorectal or non-small cell lung cancers
- Group 2: Patients with BRAF mutated colorectal cancer
- Group 3: Patients with BRAF mutated melanoma who have progressed on, or are refractory to BRAF and/or MEK inhibitors
- Group 4: Patients with NRAS mutated melanoma
- Group 5: Patients with MEK mutated cancer
- Group 6: Patients with BRAF mutated non-small cell lung cancer
- Group 7: Patients with ERK mutated cancer
You may not qualify if…
- Gastrointestinal condition which could impair absorption of study medication
- Uncontrolled or severe intercurrent medical condition
- Known uncontrolled brain metastases. Stable brain metastases either treated or being treated with a stable dose of steroids/anticonvulsants
- Any cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy, biologic or immunotherapy, etc.) within 28 days or 5 half-lives, whichever is shorter
- Major surgery within 4 weeks prior to first dose
- Any use of an investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of BVD-523.
- Pregnant or breast-feeding women
- Any evidence of serious active infections
- Any important medical illness or abnormal laboratory finding that would increase the risk of participating in this study
- A history or current evidence/risk of retinal vein occlusion or central serous retinopathy
- Concurrent therapy with any other investigational agent
- Concomitant malignancies or previous malignancies with less than 2 years disease-free interval at the time of enrollment
Where it is running
- UCLA Med-Hematology & Oncology — Los Angeles, California, United States
- Yale Cancer Center — New Haven, Connecticut, United States
- Florida Cancer Specialists and Research Group (Sarah Cannon Research Institute) — Sarasota, Florida, United States
- Massachusetts General Hospital (MGH) — Boston, Massachusetts, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
- Sarah Cannon Research Institute Hospital at Vanderbilt — Nashville, Tennessee, United States
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
- UT M.D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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