Brief Title
A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma
Official Title
A Phase I/II Clinical Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma
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).
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Phase1: Assessment of safety of BBI608 given in combination with Pemetrexed and Cisplatin by reporting the adverse events and serious adverse events.
Secondary Outcome
Phase1: Anti-tumor activity
Condition
Malignant Pleural Mesothelioma
Intervention
BBI608
Study Arms / Comparison Groups
BBI608 puls pemetrexed and cisplatin
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
24
Start Date
February 2015
Completion Date
May 31, 2018
Primary Completion Date
May 31, 2018
Eligibility 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.
Gender
All
Ages
20 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Sumitomo Dainippon Pharma Co. Ltd. Japan, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT02347917
Organization ID
D8807005
Responsible Party
Sponsor
Study Sponsor
Sumitomo Dainippon Pharma Co., Ltd.
Study Sponsor
Sumitomo Dainippon Pharma Co. Ltd. Japan, Study Director, Sumitomo Dainippon Pharma Co., Ltd.
Verification Date
November 2018