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

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ClinicalTrials.gov Identifier: NCT02347917
Recruitment Status : Completed
First Posted : January 28, 2015
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Non-Small Cell Lung Cancer Drug: BBI608 Drug: Pemetrexed Drug: Cisplatin Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Clinical Study of BBI608 in Combination With Pemetrexed and Cisplatin in Adult Patients With Malignant Pleural Mesothelioma
Actual Study Start Date : February 2015
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018


Arm Intervention/treatment
Experimental: BBI608 puls pemetrexed and cisplatin Drug: BBI608
480 mg orally twice daily (960 mg total daily dose)

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).

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).




Primary Outcome Measures :
  1. 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 ]
  2. Phase1: Assessment of dose-limiting toxicities (DLTs). [ Time Frame: 23days ]
  3. 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 ]
  4. Phase2: Progression Free Survival (PFS) [ Time Frame: 17months ]

Secondary Outcome Measures :
  1. Phase1: Anti-tumor activity [ Time Frame: 17months ]
  2. Phase1: Progression Free Survival(PFS) [ Time Frame: 17months ]
  3. Phase1: Overall Survival(OS) [ Time Frame: 17months ]
  4. Phase2: Overall Survival (OS) [ Time Frame: 17months ]
  5. Phase2: Response Rate(RR) [ Time Frame: 17months ]
  6. Phase2: Disease Control Rate(DCR) [ Time Frame: 17months ]
  7. Phase2: Vital Capacity(VC) [ Time Frame: 17months ]
  8. Phase2: Forced vital capacity(FVC) [ Time Frame: 17months ]
  9. Phase2: Forced Expiratory Volume in 1st second(FEV1) [ Time Frame: 17months ]
  10. Phase2: Safety by reporting the adverse events and serious adverse events. [ Time Frame: 17months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347917


Locations
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Japan
National Cancer Center Hospital East
Chiba, Japan
National Cancer Center Hospital
Tokyo, Japan
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
Investigators
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Study Director: Sumitomo Dainippon Pharma Co. Ltd. Japan Sumitomo Dainippon Pharma Co., Ltd.

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Responsible Party: Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT02347917     History of Changes
Other Study ID Numbers: D8807005
First Posted: January 28, 2015    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Mesothelioma
Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Cisplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors