NCT02347917 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2022-04-12

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Phase 1 Part: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADRs)

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outcome · POSTED

Phase 1 Part: Number of Participants With Dose-limiting Toxicities (DLTs)

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outcome · POSTED

Phase 1 Part: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of BBI608 When Administered With Pem and CDDP

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outcome · POSTED

Phase 1 Part: Area Under the Concentration-time Curve

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outcome · POSTED

Phase 2 Part: Progression-free Survival (PFS)

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outcome · POSTED

Best Overall Response

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outcome · POSTED

Response Rate (RR) and Disease Control Rate (DCR)

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outcome · POSTED

Overall Survival(OS)

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outcome · POSTED

Respiratory Function Tests (Vital Capacity [VC] and Forced Vital Capacity [FVC])

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outcome · POSTED

Respiratory Function Tests (Forced Expiratory Volume in the First Second [FEV1])

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
minimum Age: 20 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: BBI608
Drug: Pemetrexed
Drug: Cisplatin
label
BBI608 puls pemetrexed and cisplatin
type
EXPERIMENTAL

interventions

arm Group Labels
BBI608 puls pemetrexed and cisplatin
description
480 mg orally twice daily (960 mg total daily dose)
name
BBI608
type
DRUG
arm Group Labels
BBI608 puls pemetrexed and cisplatin
description
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).
name
Pemetrexed
type
DRUG
arm Group Labels
BBI608 puls pemetrexed and cisplatin
description
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).
name
Cisplatin
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 28
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
An AE is any untoward medical occurrence in a study subject administered an investigational drug and which does not necessarily have a causal relationship with this treatment. A SAE was an AE that met one or more of the following criteria: * Results in death * Is life-threatening * Requires hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability or incapacity * Is a congenital anomaly or birth defect * Is an important medical event that may jeopardize the subject or may require a medical or surgical intervention to prevent one of the outcomes listed above. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization. An ADR was defined as adverse events assessed to be related to the investigational drug
measure
Phase 1 Part: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADRs)
time Frame
Between initial dosing of the investigational drug and final evaluation in the follow-up observation period, about 17 months
description
DLT was defined as an adverse event meeting any of the following that occurred during the DLT evaluation period in any participants given BBI608 with the causal relationship to BBI608 assessed as "Definite," "Probable," or "Possible." The severity of adverse events was graded according to the CTCAE v4.0-JCOG. * Grade 4 neutropenia persisting for ≥ 7 days * Grade ≥ 3 febrile neutropenia persisting for ≥ 5 days * Grade 3 thrombocytopenia requiring platelet transfusions, grade 4 thrombocytopenia * Grade ≥ 3 non-hematotoxicity except the following: 1. Inappetence, nausea, vomiting and electrolyte abnormality which, within 3 days of onset, improved to grade ≤ 2 or resolved after appropriate treatment 2. Diarrhoea and fatigue which, within 5 days of onset, improved to grade ≤ 2 or resolved after appropriate treatment * Other clinically significant signs in the opinion of the investigator
measure
Phase 1 Part: Number of Participants With Dose-limiting Toxicities (DLTs)
time Frame
From Day 1 of Cycle 1 to Day 24 pre-dose examination (23 days)
measure
Phase 1 Part: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) of BBI608 When Administered With Pem and CDDP
time Frame
Cycle 1 Day 1 (Cmax only) and Day 23
description
AUC0-12: Area under the concentration-time curve from time zero to 12 hours, AUC0-24: Area under the concentration-time curve from time zero to 24 hours, AUC0-inf: Area under the concentration-time curve from time zero to infinity
measure
Phase 1 Part: Area Under the Concentration-time Curve
time Frame
Cycle 1 Day 1 and Day 23
description
PFS was defined as the time from BBI608 administration to documented PD (as assessed according to the mRECIST or RECIST 1.1) or death, whichever is earlier. The result of imaging assessment by the imaging assessment committee was used for phase 2 part.
measure
Phase 2 Part: Progression-free Survival (PFS)
time Frame
From BBI608 administration to documented PD or death, whichever is earlier, about 17 months

secondary Outcomes

description
The best overall response is the best response recorded from the start of the study treatment until the end of treatment. The RECIST 1.1 was used for the evaluation of tumor response and overall response in patients with NSCLC, and also the evaluation of any non-pleural lesions in patients with MPM. The mRECIST was used for the evaluation of tumor response and overall response in patients with MPM. The result of imaging assessment by study site was used for phase 1 part, and the result of imaging assessment by the imaging assessment committee was used for phase 2 part.
measure
Best Overall Response
time Frame
Every 6 weeks from the first dose of BBI608 until Week 30, and every 9 weeks from Week 31.
description
Response rate (RR): Proportion of subjects whose best overall response is CR or PR. Disease control rate (DCR): Proportion of subjects whose best overall response is CR, PR or SD. The result of imaging assessment by study site was used for phase 1 part, and the result of imaging assessment by the imaging assessment committee was used for phase 2 part.
measure
Response Rate (RR) and Disease Control Rate (DCR)
time Frame
From BBI608 administration to death from any cause, about 17 months
description
OS was defined as the time from BBI608 administration to death from any cause. Participants alive at final observation or lost to follow-up were censored at their last contact (i.e., visit or telephone) date.
measure
Overall Survival(OS)
time Frame
From BBI608 administration to death from any cause, up to 31 months
measure
Respiratory Function Tests (Vital Capacity [VC] and Forced Vital Capacity [FVC])
time Frame
Every 6 weeks from the first dose of BBI608 until Week 30, and then every 9 weeks from Week 31 [Actually up to Week 111]
measure
Respiratory Function Tests (Forced Expiratory Volume in the First Second [FEV1])
time Frame
Every 6 weeks from the first dose of BBI608 until Week 30, and then every 9 weeks from Week 31 [Actually up to Week 111]

Full study description

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).

Source references

Source notices and limitations

Discovery and provenance

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query cond
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Preserved source evidence · Not medical advice