| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00548093 | PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And Erlotinib | PHASE2 | COMPLETED | 66 | — | — | Apr 29, 2008 | Jun 11, 2012 | May 21, 2019 | 19 | United States |
| NCT00553254 | Trial Of PF-00299804 In Patients With Advanced Refractory Lung Cancer | PHASE2 | COMPLETED | 55 | — | — | Feb 5, 2008 | Jul 17, 2014 | Oct 19, 2020 | 3 | South Korea |
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.
The highest dose at which less than (\<) 33 percent (%) of participants experienced dose-limiting toxicities (DLT) was to be designated as the maximum tolerated dose (MTD) as well as the RP2D. DLT was defined as any of the following events: Grade 3/4 (severe or life-threatening/ disabling adverse event \[AE\]) nausea, vomiting, or diarrhea (despite the use of adequate/maximal medical intervention and/or prophylaxis); Grade greater than or equal to (\>=) 3 (severe or life-threatening/disabling AE or death related to AE) non-hematological toxicity; delayed (which delayed scheduled treatment for \>14 days) recovery from toxicity related to treatment with PF-00299804; Grade 4 neutropenia (absolute neutrophil count \[ANC\] \<500 cells per cubic millimeter \[cells/mm\^3\] for 5 or more consecutive days or febrile neutropenia \[fever \>=38.5 degrees Celsius with ANC \<1000 cells/mm\^3\]); and Grade 4 thrombocytopenia (\<25,000 cells/mm\^3) or bleeding which required platelet transfusion.
PFS4m was defined as percent chance of being event free (event defined as progressive disease \[PD\] or death due to any cause, whichever occurred first) at 4 months. Progression was defined using Response Evaluation Criteria in Solid Tumors (RECIST), as at least 20 percent (%) increase in the sum of longest dimensions (LD) of target lesions, taking as reference the smallest sum of LD recorded since the treatment started and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | descriptive: adenocarcinoma histology |
| 2 | EXPERIMENTAL | descriptive: non-adenocarcinoma histology |
| Name | Type | Description |
|---|---|---|
| PF-00299804 | DRUG | PF-00299804 orally at 45 mg daily, on continuous schedule |
Inclusion Criteria: * Advanced Non-Small Cell Lung Cancer (NSCLC) * Prior treatment with and failure of at least one regimen of chemotherapy and erlotinib. * Prior treatment with no more than two chemotherapy regimens, including adjuvant or combined modality treatment. * Measurable disease . * East...