Trial Outcomes & Findings for BELotaxel(Docetaxel) and bellOXa(Oxaliplatin) in Advanced NSCLC (NCT NCT01243775)

Results Overview

RECIST version 1.1

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

6th week

Results posted on

2015-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	Belotaxel Plus Belloxa Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
Overall Study STARTED	33
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Belotaxel Plus Belloxa Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
Overall Study Withdrawal by Subject	2

Baseline Characteristics

BELotaxel(Docetaxel) and bellOXa(Oxaliplatin) in Advanced NSCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Belotaxel Plus Belloxa n=33 Participants Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
Age, Continuous	64.0 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Race/Ethnicity, Customized Korean	33 participants n=5 Participants
Region of Enrollment Korea, Republic of	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 6th week

Population: Intention to treat population

RECIST version 1.1

Outcome measures

Outcome measures
Measure	Belotaxel Plus Belloxa n=33 Participants Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
Response Rate	11 participants

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Belotaxel Plus Belloxa n=33 Participants Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
Progression Free Survival	3.6 months Interval 2.8 to 4.5

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Belotaxel Plus Belloxa n=33 Participants Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
Overall Survival	10.9 months Interval 8.2 to 13.6

SECONDARY outcome

Timeframe: 2 years

Toxicity (CECAE ver 4.0) and Safety

Outcome measures

Outcome measures
Measure	Belotaxel Plus Belloxa n=33 Participants Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
Neutropenia Grade 3-4	17 participants

Adverse Events

Belotaxel Plus Belloxa

Serious events: 10 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Belotaxel Plus Belloxa n=33 participants at risk Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
Blood and lymphatic system disorders Febrile Neutropenia	6.1% 2/33 • Number of events 2 • 4 months
Vascular disorders Thromboembolism	3.0% 1/33 • Number of events 1 • 4 months
Infections and infestations Infection	21.2% 7/33 • Number of events 7 • 4 months

Other adverse events

Other adverse events
Measure	Belotaxel Plus Belloxa n=33 participants at risk Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
Gastrointestinal disorders Anorexia	63.6% 21/33 • 4 months
Gastrointestinal disorders Diarrhea	36.4% 12/33 • 4 months

Additional Information

Dr. Young-Chul Kim

Chonnam National University Hwasun Hospital

Phone: 82-61-379-7614

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place