Trial Outcomes & Findings for Phase II Study of Sorafenib + Carboplatin and Docetaxel in First Line Treatment of Stage IIIB/IV NSCLC (NCT NCT00647426)

Last Updated: 2019-10-22

Results Overview

The response rate from the combination therapy of Sorafenib and Docetaxel/carboplatin for patients with Stage IIIB/IV NSCLC.The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria (see section 9.3.1).Tumor Response: Evaluation of target lesions Complete Response (CR): Disappearance of all target lesions Partial Response (PR): a) At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): a) At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

30 months

Results posted on

2019-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Sorafinb + Docetoxel+Carboplatin 400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle Sorafenib + Docetaxel/Carboplatin: 400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle
Overall Study STARTED	7
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Sorafinb + Docetoxel+Carboplatin 400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle Sorafenib + Docetaxel/Carboplatin: 400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Phase II Study of Sorafenib + Carboplatin and Docetaxel in First Line Treatment of Stage IIIB/IV NSCLC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafinb + Docetoxel+Carboplatin n=7 Participants 400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle Sorafenib + Docetaxel/Carboplatin: 400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 months

Population: Sufficient data was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 months

Population: Sufficient data was not collected.

Disease progression is based on RECIST documentation. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 months

Population: Sufficient data was not collected.

Assessment of adverse events related to the combination infusion, These include a Serious Adverse Event (SAE) is an adverse event occurring at any dose that results in any of the following outcomes: 1. Death 2. Life-threatening 3. Persistent or significant disability/incapacity 4. In patient hospitalization or prolongation of existing hospitalization 5. Congenital anomaly/birth defect or • blood dyscrasia without inpatient hospitalization * convulsions without inpatient hospitalization * intensive treatment in an emergency room or at home for allergic bronchospasm without inpatient hospitalization * development of drug dependency * drug abuse * overdose with an associated serious event, or required intervention to prevent impairment/damage

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 months

Population: Sufficient data was not collected.

Monitored at designated timepoints.All patients will be evaluable for toxicity from the time of their first treatment with SORAFENIB.

Outcome measures

Outcome data not reported

Adverse Events

Sorafenib + Docetaxel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tracey Evans MD

Abramson Cancer Center

Phone: 215 614 0861

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place