A Phase 1 Dose Escalation Study of VS-5584 Administered in Combination With VS-6063, in Subjects With Relapsed Malignant Mesothelioma

Stopped early · Phase 1

Conditions studied: Relapsed Malignant Mesothelioma

In brief

The purpose of this study is to evaluate rising dose levels of VS-5584 administered in combination with a fixed dose of VS-6063 in subjects with relapsed malignant mesothelioma to determine a recommended Phase 2 dose (RP2D) for further development of this combination in this indication.

Key facts

Study ID

NCT02372227

Run by

Verastem, Inc.

People needed

21

Starts

2015-01-01

Expected to finish

2015-10-01

Last updated by the study team

2017-01-30

Who can join

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

You may qualify if…

• Histopathologically-confirmed diagnosis of malignant mesothelioma (pleural or peritoneal). Must have disease that has relapsed following at least one prior line of chemotherapy.
• Must have received at least 3 cycles of first-line chemotherapy.
• Evaluable or measurable disease as assessed by Response Evaluation Criteria in Solid Tumors (RECIST).
• Must have archival tumor tissue available for biomarker analysis. A study-specific tumor core biopsy, pleural effusion or ascites sample must be obtained prior to treatment if archival tissue is not available.
• Performance status according to the Karnofsky Performance Scale ≥70%.
• Fasting blood glucose of ≤ 140 mg/dL (7.8 mmol/L).
• Adequate renal function (creatinine ≤ 1.5x upper limit of normal [ULN]) and/or glomerular filtration rate (GFR) of ≥50 mL/min.
• Adequate hepatic function (total bilirubin ≤ 1.5x ULN; AST and ALT ≤ 3x ULN).
• Adequate bone marrow function (hemoglobin ≥9.0 g/dL; platelets ≥100 x10\^9 cells/L; absolute neutrophil count ≥1.5x10\^9 cells/L) without the use of hematopoietic growth factors.

You may not qualify if…

• Have had a previous extra pleural pneumonectomy (EPP).
• Gastrointestinal condition which could interfere with the swallowing or absorption of study drug.
• Uncontrolled or severe concurrent medical condition (including uncontrolled brain metastases).
• Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of study drug.
• Any evidence of serious active infection.
• Undergoing active treatment for a secondary malignancy.
• Cancer-directed therapy (chemotherapy, radiotherapy) within 21 days of the first dose of study drug or 5 half-lives, whichever is shorter.
• Major surgery within 28 days prior to the first dose of study drug.
• Acute or chronic pancreatitis.
• Diabetes mellitus requiring insulin treatment or subjects with a hemoglobin A1C (HbA1C) >7%.
• History or evidence of cardiac risk.
• Known history of malignant hypertension.

Where it is running

• The University of Chicago Medical Center — Chicago, Illinois, United States
• Memorial Sloane Kettering Cancer Center — New York, New York, United States
• University of Leicester — Leicester, United Kingdom
• The Institute of Cancer Research — Sutton Surrey, United Kingdom

Full record on ClinicalTrials.gov

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