Trial Outcomes & Findings for Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer (NCT NCT00754923)

Results Overview

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

6 months

Results posted on

2019-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment: Sorafenib Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle. sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sorafenib in Treating Non-Smokers or Former Light Smokers With Relapsed or Refractory Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment: Sorafenib n=11 Participants Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle. sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate

Outcome measures

Outcome measures
Measure	Treatment: Sorafenib n=11 Participants Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle. sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
Progression-free Survival at 6 Months	11 participants

SECONDARY outcome

Timeframe: Up to 2 years

Determine the one year survival rate in Non/Light smokers with advanced and previouslytreated NSCLC

Outcome measures

Outcome measures
Measure	Treatment: Sorafenib n=11 Participants Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle. sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
Overall Survival Rate	8.8 months Interval 2.4 to 16.8

SECONDARY outcome

Timeframe: Up to 2 years

Assess the frequency and severity of adverse events associated with Sorafenib in this patient population Non/Light smokers with advanced and previously treated NSCLC.

Outcome measures

Outcome measures
Measure	Treatment: Sorafenib n=11 Participants Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle. sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
Incidence of Adverse Events Sssessed by Common Terminology Criteria for Adverse Events (CTCAE) Fatigue	9 percentage of participants
Incidence of Adverse Events Sssessed by Common Terminology Criteria for Adverse Events (CTCAE) Rash	55 percentage of participants

SECONDARY outcome

Timeframe: up to 2 years

Outcome measures

Outcome measures
Measure	Treatment: Sorafenib n=7 Participants Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle. sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
Mutational Status for EGFR or Kras	7 participants

Adverse Events

Treatment: Sorafenib

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment: Sorafenib n=11 participants at risk Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle. sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
Musculoskeletal and connective tissue disorders Fatigue	9.1% 1/11 • Number of events 1

Other adverse events

Other adverse events
Measure	Treatment: Sorafenib n=11 participants at risk Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle. sorafenib: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.
Skin and subcutaneous tissue disorders rash/hand-foot syndrome	54.5% 6/11

Additional Information

Miguel Villalona

OSU

Phone: 614-366-5068

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60