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PF-00299804

Phase 2

Carcinoma, Non Small Cell Lung | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Oct 19, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials2
Total Enrollment121
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00548093PF-00299804 As A Single Agent, In Patients With Advanced Non-Small Cell Lung Cancer Who Have Failed Chemotherapy And ErlotinibPHASE2 COMPLETED 66Apr 29, 2008Jun 11, 2012May 21, 201919 United States
NCT00553254Trial Of PF-00299804 In Patients With Advanced Refractory Lung CancerPHASE2 COMPLETED 55Feb 5, 2008Jul 17, 2014Oct 19, 20203 South Korea
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Study Endpoints
Primary Endpoints
Best Overall Response (BOR) in Participants With Adenocarcinoma Histology
Baseline, end of every even-numbered cycle up to end of treatment (Day 936)

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.

Recommended Phase 2 Dose (RP2D) - Phase 1
Baseline up to Day 21

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.

Progression-Free Survival (PFS) at Month 4 (PFS4m) - Phase 2
Month 4

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.

Secondary Endpoints
Best Overall Response (BOR) in Participants With Non-Adenocarcinoma Histology
Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
Duration of Response (DR)
Baseline, end of every even-numbered cycle up to end of treatment (Day 936)
Percent Probability of Progression-free Survival (PFS) at Month 6
Up to 6 months after the start of study medication
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALdescriptive: adenocarcinoma histology
2EXPERIMENTALdescriptive: non-adenocarcinoma histology
Interventions
NameTypeDescription
PF-00299804DRUGPF-00299804 orally at 45 mg daily, on continuous schedule
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites19

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...

Countries:United StatesSouth Korea
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