A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma

• Status: Completed
• Trial end date: 2018-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicenter, phase 1/2 study of BBI608 in combination with pemetrexed and cisplatin chemotherapy as a 1st line treatment for Malignant Pleural Mesothelioma (MPM).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sumitomo Dainippon Pharma Co., Ltd.
• Treatments: Cisplatin; Pemetrexed

Criteria

Phase 1

Inclusion Criteria:

• Histologically confirmed diagnosis of Malignant Pleural Mesothelioma (MPM) or Non-Small Cell Lung Cancer (NSCLC).

• Measurable disease as defined by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) for MPM or the RECIST 1.1 for NSCLC.

• ≥ 20 years of age.

• Provision of written informed consent.

• For male or female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last protocol treatment dose.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

• Hemoglobin (Hb) ≥ 9.0 g/dL.

• Neutrophils ≥ 1500/μL.

• Platelets ≥ 100,000/μL.

• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5-fold the upper limit of normal range (ULN) [≤ 5-fold ULN with any liver metastasis].

• Total bilirubin ≤ 1.5-fold ULN.

• Creatinine clearance (estimated value) ≥ 60 mL/min.

• Life expectancy ≥ 3 months.

• Females of childbearing potential have a negative urine pregnancy test.

Phase 2

Inclusion Criteria:

• Histologically confirmed diagnosis of MPM.

• Treatment naïve and not indicated for resection.

• Measurable disease as defined by the modified RECIST.

• ≥ 20 years of age.

• Provision of written informed consent.

• For male or female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last protocol treatment dose.

• ECOG Performance Status of 0 or 1.

• Hb ≥ 9.0 g/dL.

• Neutrophils ≥ 1500/μL.

• Platelets ≥ 100,000/μL.

• AST and ALT ≤ 2.5-fold ULN [≤ 5-fold ULN for patients with any liver metastasis].

• Total bilirubin ≤ 1.5-fold ULN.

• Creatinine clearance (estimated value) > 60 mL/min.

• Life expectancy ≥ 3 months.

• Females of childbearing potential have a negative urine pregnancy test.

Both Phase 1 and 2

Exclusion Criteria:

• Prior anti-cancer chemotherapy and radiotherapy.

• Prior hormonal therapy, immunotherapy, thermotherapy, operation.

• Any brain metastasis requiring treatment or symptomatic.

• Active multiple primary cancers.

• Crohn's disease, ulcerative colitis, small intestine resection.

• Abnormal ECGs.

• Prior myocardial infarction.

• Current use of antiarrhythmic medication.

• Uncontrolled concurrent diseases.

• Known severe hypersensitivity to pemetrexed, cisplatin or other drugs containing platinum.

• Women who are pregnant or breastfeeding.

• Received other investigational drugs.

• Unable or unwilling to swallow BBI608 capsules daily.

• Prior treatment with BBI608.

• Ineligible for participation in the study in the opinion of the Investigators.