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

Sumitomo Pharma

Status and phase

Completed

Phase 2

Phase 1

Conditions

Malignant Pleural Mesothelioma

Non-Small Cell Lung Cancer

Treatments

Drug: Cisplatin

Drug: BBI608

Drug: Pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT02347917

D8807005

Details and patient eligibility

About

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).

Enrollment

28 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.