Study of BMS-986012 in Subjects With Small Cell Lung Caner

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02949895
• Collaborator: (none)
• Enrollment: 7
• Locations: 2
• Arms: 3
• Actual Duration (Months): 9
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

A study to evaluate safety and tolerability of BMS-986012 in patients with small cell lung cancer

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Drug: BMS-986012; Drug: Cisplatin; Drug: Etoposide	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Study of the Safety and Tolerability of BMS-986012 in Subjects With Small Cell Lung Cancer
• Actual Study Start Date: Nov 29, 2016
• Actual Primary Completion Date: Aug 29, 2017
• Actual Study Completion Date: Aug 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalation Dose 1 BMS-986012 Dose Escalation Dose 1	Drug: BMS-986012
Experimental: Dose Escalation Dose 2 BMS-986012 Dose Escalation Dose 2	Drug: BMS-986012
Experimental: Chemotherapy Combination BMS-986012 + Cisplatin + Etoposide	Drug: BMS-986012; Drug: Cisplatin; Drug: Etoposide

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events (AEs) [Up to 2 years]

2. Number of participants with serious adverse events (SAEs ) [Up to 2 years]

3. Number of Discontinuations due to AEs [Up to 2 years]

4. Number of Deaths due to AEs [Up to 2 years]

5. Number of participants with laboratory toxicity grade shift from baseline [Up to 2 years]

Secondary Outcome Measures

1. Maximum observed serum concentration (Cmax) [Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose]

2. Time of maximum observed serum concentration(Tmax) [Cycle 1(each cycle is 21 days) Day 1 up to 60 days after last dose]

3. 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]

4. 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]

5. 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]

6. 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]

7. Best overall response (BOR) [Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years]

8. Duration of response (DOR) [Cycle 1(each cycle is 21 days) Day 1 up to approximately 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

• Histological or cytological confirmed small cell lung cancer (SCLC)

• Eastern Cooperative Oncology Group Performance Status 0-1

• at least one measurable lesion that is not amenable to resection.

• Adequate organ function

Exclusion Criteria:

• Symptomatic central nervous system (CNS) metastases

• Grade ≥ 2 peripheral neuropathy

• Uncontrolled or significant cardiac disease

• Active or chronic infection with Human Immunodeficiency Virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV)

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Takatsuki-shi	Osaka	Japan	5698686
2	Local Institution	Chuo-ku	Tokyo	Japan	1040045

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Patient Recruiting

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT02949895
• Other Study ID Numbers: CA001-045
• First Posted: Oct 31, 2016
• Last Update Posted: Aug 12, 2019
• Last Verified: Aug 1, 2019

• Additional relevant MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Etoposide

Study Results

No Results Posted as of Aug 12, 2019