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A 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).

Tracking Information
First Received DateJanuary 21, 2015
Last Changed DateJuly 19, 2016
Start DateFebruary 2015
Anticipated Primary Completion DateMay 2017
Primary Outcome Measures

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 Outcome Measures

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]

Descriptive Information
PhasePhase 1/Phase 2
Study TypeInterventional
Condition
  • Malignant Pleural Mesothelioma
  • Non-Small Cell Lung Cancer
Intervention
  • Drug: BBI608
  • Drug: Pemetrexed
  • Drug: Cisplatin
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusActive, not recruiting
Actual Enrollment24
GenderAll
Ages20 Years - N/A
Accepts Healthy VolunteersNo
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.

Administrative Information
NCTIDNCT02347917
Responsible Party,
SponsorSumitomo Dainippon Pharma Co., Ltd.
Verification DateJuly 2016
Mesothelioma Doctors by State
  • Trust Funds Set Aside
  • VA Benefits Available
  • Delivered within 24 hrs

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