Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02347917 : A Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma
PhasePhase 1/Phase 2
AgesMin: 20 Years Max: N/A
Eligibility
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/?L.

- Platelets ? 100,000/?L.

- 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/?L.

- Platelets ? 100,000/?L.

- 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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02347917      |      Link to official Clinicaltrials.gov listing
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