Study Evaluating HKI-272 in Tumors | NCT00146172

NCT00146172

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Neratinib 40 mg	Experimental	Drug: neratinib
Neratinib 80 mg	Experimental	Drug: neratinib
Neratinib 120 mg	Experimental	Drug: neratinib
Neratinib 180 mg	Experimental	Drug: neratinib
Neratinib 240 mg	Experimental	Drug: neratinib
Neratinib 320 mg	Experimental	Drug: neratinib
Neratinib 400 mg	Experimental	Drug: neratinib
Neratinib 320 mg MTD	Experimental

Name	Type	Description	Arm Group Labels	Other Names
neratinib	Drug	HKI-272	Neratinib 120 mg Neratinib 180 mg Neratinib 240 mg Neratinib 320 mg Neratinib 320 mg MTD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose Limiting Toxicity (DLT)	DLT is defined as any neratinib-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) common terminology criteria (CTC) for AEs version 3.0. DLTs were assessed from the first single dose to 14 days of continuous daily administration.	From first dose date to day 14
Maximum Tolerated Dose (MTD)	If 2 or more, of 3 to 6 subjects, at a dose level had an neratinib-related dose limiting toxicity (DLT) by day 14 of continuous daily dose administration, dose escalation stopped and the prior dose level was considered the MTD.	From first dose date to day 14

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Best Overall Response	Best Overall response by tumor type, evaluable population per Response Evaluation Criteria In Solid Tumors Criteria v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in sum of the longest diameter (LD) of target lesions in reference to baseline sum of LD of target lesions; Progressive Disease (PD), >=20% increase in sum of LD of target lesions, taking as reference the smallest sum of recorded LD of target lesions since treatment started or appearance of 1 or more new lesions; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of LD of target lesions since the treatment start. The best overall response was the best response recorded from start of treatment until PD/recurrence. In general, the subject's best response assignment depended on achievement of both measurement and confirmation criteria.

Eligibility Module

Name	Affiliation	Role
Puma	Biotechnology	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
H. Lee Moffitt Cancer Center & Research Institute		Tampa	Florida	33612	United States
Dana-Farber Cancer Institute

Arm/Group Information

ID	Title	Description
FG000	Neratinib 40 mg	Neratinb 40 mg qd
FG001	Neratinib 80 mg	Neratinib 80 mg qd
FG002	Neratinib 120 mg	Neratinib 120 mg qd
FG003	Neratinib 180 mg	Neratinib 180 mg qd
FG004	Neratinib 240 mg	Neratinib 240 mg qd
FG005	Neratinib 320 mg	Neratinib 320 mg qd
FG006	Neratinib 400 mg	Neratinib 400 mg qd
FG007	Neratinib MTD	Neratinib maximum tolerated dose (320 mg).

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG0003 subjects FG0014 subjects FG0024 subjects FG0036 subjects FG0043 subjects FG0057 subjects FG0066 subjects FG00740 subjects
Received Drug		FG0003 subjects FG0014 subjects FG0024 subjects FG0036 subjects FG004
COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
NOT COMPLETED		FG0003 subjects FG0014 subjects FG0024 subjects FG0036 subjects FG004

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0010 subjects FG0021 subjects FG003

Baseline Characteristics Module

ID	Title	Description
BG000	Neratinib 40 mg	Neratinb 40 mg qd
BG001	Neratinib 80 mg	Neratinib 80 mg qd

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Dose Limiting Toxicity (DLT)

DLT is defined as any neratinib-related nonhematologic grade 3 or any grade 4 adverse event (AE) according to the National Cancer Institute (NCI) common terminology criteria (CTC) for AEs version 3.0. DLTs were assessed from the first single dose to 14 days of continuous daily administration.

Subjects in the dosing groups 40 mg through 400 mg, excluding the selection of MTD.

Posted

Count of Participants

Participants

From first dose date to day 14

ID	Title	Description
OG000	Neratinib 40 mg	Neratinb 40 mg qd
OG001	Neratinib 80 mg	Neratinib 80 mg qd

Adverse Events Module

ID	Term
D001943	Breast Neoplasms
D009369	Neoplasms

ID	Term
D009371	Neoplasms by Site
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases