PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib

BOR:best response recorded from treatment start until disease progression as per Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response: disappearance of all lesions. Partial Response (PR):greater than or equal to (\>=)30% decrease in sum of longest diameters (SLDs) of target lesions (TLs) taking as reference baseline SLD. Progressive disease (PD):\>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of \>=1 new lesion. Stable disease:neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.

Time frame: Baseline, end of every even-numbered cycle up to end of treatment (Day 936)

Population: Response-evaluable population included all enrolled participants who received at least 1 dose of study treatment, with adequate baseline tumor assessment and at least 1 on-study tumor assessment after the first dosing.

The pharmacokinetic (PK) samples collected between 22-26 hours post dose on Day 1 of Cycle 1 were within the pre-specified time window for the 24-hour post dose sample and were used for calculation of AUC (0-24) on Day 1 of Cycle 1.

Time frame: 0.5-2, 3-5, 6-8, 22-26 hours post dose on Day 1 of Cycle 1

Population: PK concentration population included all enrolled participants who received at least 1 dose of study treatment and had at least 1 measured plasma concentration. Here, 'N' (overall number of participants analyzed) signifies those participants who were evaluable for the measure.

BOR: best response recorded from treatment start until disease progression as per RECIST. Complete Response: disappearance of all lesions. PR: \>=30% decrease in SLDs of TLs taking as reference baseline SLD. PD: \>=20% increase in SLD of TLs taking as reference smallest SLD since treatment start, or appearance of \>=1 new lesion. Stable disease: neither shrinkage for PR nor increase for PD taking as reference smallest SLD since treatment start.

Time frame: Baseline, end of every even-numbered cycle up to end of treatment (Day 936)

Population: Response-evaluable population included all enrolled participants who received at least 1 dose of study treatment, with adequate baseline tumor assessment and at least 1 on-study tumor assessment after the first dosing.

Self-administered questionnaire to measure health-related quality of life (QoL) of adult participants suffering from skin disease; 10 questions concerning participants' perception of impact of their disease over last week encompassing aspects such as symptoms or feelings, daily activities, leisure, work or school, personal relationships and treatment. Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much). Scores of individual questions (0-3) were added to yield a total score (0-30); higher score = greater impairment of participant's QoL.

Time frame: Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43

Population: As-enrolled population included all participants who were enrolled in the study. Here, 'N' signifies those participants who were evaluable for the measure and 'number analyzed' signifies participants evaluable at each time point for each arm respectively.

Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.

Time frame: Baseline, end of every even-numbered cycle up to end of treatment (Day 936)

Population: DR was calculated for the subgroup of participants from the response-evaluable population, with a confirmed objective tumor response (CR or PR).

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.

Time frame: Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43

Population: As-enrolled population included all participants who were enrolled in the study. Here, 'N' signifies those participants who were evaluable for the measure and 'number analyzed' signifies participants evaluable at each time point for each arm respectively.

QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprised 1 multi-item scale for dyspnoea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.

Time frame: Baseline (C1D1), C2D1 thereafter every subsequent cycle up to C43

Population: As-enrolled population included all participants who were enrolled in the study. Here, 'N' signifies those participants who were evaluable for the measure and 'number analyzed' signifies participants evaluable at each time point for each arm respectively.