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

NCT ID: NCT02347917

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-05-31

Brief 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).

Conditions

Malignant Pleural Mesothelioma; Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BBI608 puls pemetrexed and cisplatin

Group Type: EXPERIMENTAL

BBI608

Intervention Type: DRUG

480 mg orally twice daily (960 mg total daily dose)

Pemetrexed

Intervention Type: DRUG

500 mg/m2 I.V. infusion on Day 1 of each treatment cycle (except for cycle 1, in which Pemetrexed will be given on Day 3).

Cisplatin

Intervention Type: DRUG

75 mg/m2 I.V. infusion on Day 1 of each treatment cycle (except for Cycle 1, in which Cisplatin will be given on Day 3).

Interventions

BBI608

480 mg orally twice daily (960 mg total daily dose)

Intervention Type: DRUG

Pemetrexed

500 mg/m2 I.V. infusion on Day 1 of each treatment cycle (except for cycle 1, in which Pemetrexed will be given on Day 3).

Intervention Type: DRUG

Cisplatin

75 mg/m2 I.V. infusion on Day 1 of each treatment cycle (except for Cycle 1, in which Cisplatin will be given on Day 3).

Intervention Type: DRUG

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sumitomo Pharma Co., Ltd. Japan

Role: STUDY_DIRECTOR

Sumitomo Pharma Co., Ltd.

Locations

National Cancer Center Hospital East

Chiba, , Japan

National Cancer Center Hospital

Tokyo, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

D8807005

Identifier Type: -

Identifier Source: org_study_id