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A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Dose 1 | Experimental | BMS-986012 Dose Escalation Dose 1 |
|
| Dose Escalation Dose 2 | Experimental | BMS-986012 Dose Escalation Dose 2 |
|
| Chemotherapy Combination | Experimental | BMS-986012 + Cisplatin + Etoposide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986012 | Drug |
| ||
| Cisplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 2 years | |
| Number of participants with serious adverse events (SAEs ) | Up to 2 years | |
| Number of Discontinuations due to AEs | Up to 2 years | |
| Number of Deaths due to AEs | Up to 2 years | |
| Number of participants with laboratory toxicity grade shift from baseline | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) | Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose | |
| Time of maximum observed serum concentration(Tmax) | Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose |
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Inclusion Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Takatsuki-shi | Osaka | 5698686 | Japan | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Drug |
|
| Etoposide | Drug |
|
| Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration(AUC(0-T)) | Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose |
| Observed serum concentration at the end of a dosing interval(Ctau) | Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose |
| Area under the concentration-time curve in 1 dosing interval(AUC(TAU)) | Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose |
| Characterization of Immunogenicity as measured by Anti-Drug Antibodies (ADA) | Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose |
| Best overall response (BOR) | Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years |
| Duration of response (DOR) | Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years |
| Chuo-ku |
| Tokyo |
| 1040045 |
| Japan |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011034 |
| Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |