Overview

This trial is active, not recruiting.

Conditions malignant pleural mesothelioma, non-small cell lung cancer
Treatments bbi608, pemetrexed, cisplatin
Phase phase 1/phase 2
Target CSC
Sponsor Sumitomo Dainippon Pharma Co., Ltd.
Start date February 2015
End date May 2017
Trial size 24 participants
Trial identifier NCT02347917, D8807005

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bbi608
480 mg orally twice daily (960 mg total daily dose)
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).
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).

Primary Outcomes

Measure
Phase1: Assessment of safety of BBI608 given in combination with Pemetrexed and Cisplatin by reporting the adverse events and serious adverse events.
time frame: 17months
Phase1: Assessment of dose-limiting toxicities (DLTs).
time frame: 23days
Phase1: Pharmacokinetics profile of BBI608 when administered with pemetrexed and cisplatin.
time frame: On day 1 of the first cycle: prior to BBI608 dosing and 2,4,6,8,10,12,24 hours after the first dose, :on day 3 of the first cycle prior to BBI608 dosing,12 and 24 hours after first dose, before pemetrexed dosing, after pemetrexed dosing, before cisplatin
Phase2: Progression Free Survival (PFS)
time frame: 17months

Secondary Outcomes

Measure
Phase1: Anti-tumor activity
time frame: 17months
Phase1: Progression Free Survival(PFS)
time frame: 17months
Phase1: Overall Survival(OS)
time frame: 17months
Phase2: Overall Survival (OS)
time frame: 17months
Phase2: Response Rate(RR)
time frame: 17months
Phase2: Disease Control Rate(DCR)
time frame: 17months
Phase2: Vital Capacity(VC)
time frame: 17months
Phase2: Forced vital capacity(FVC)
time frame: 17months
Phase2: Forced Expiratory Volume in 1st second(FEV1)
time frame: 17months
Phase2: Safety by reporting the adverse events and serious adverse events.
time frame: 17months

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

Official title A Phase I/II Clinical Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Sumitomo Dainippon Pharma Co., Ltd..