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A Phase 1 Study Of Neratinib (HKI-272) In Combination With Vinorelbine In Japanese Subjects With Advanced Or Metastatic Solid Tumors

Phase 1
20 Years
Not Enrolling
Advanced Malignant Solid Tumors

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Trial Information

A Phase 1 Study Of Neratinib (HKI-272) In Combination With Vinorelbine In Japanese Subjects With Advanced Or Metastatic Solid Tumors

Inclusion Criteria:

- Confirmed pathologic diagnosis of a solid tumor that is not curable with available
therapies for which neratinib plus vinorelbine is a reasonable treatment option.

- At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid

- Eastern Cooperative Oncology Group performance status of 0 to 2 (not declining within
2 weeks before signing the informed consent form).

- Recovery from all clinically significant AEs related to prior therapies (excluding

- Left ventricular ejection fraction within the study site's limits of normal.

- Screening laboratory values within the following parameters:

- Absolute neutrophil count: 1.5 × 109/L

- Platelet count: 100 × 109/L

- Hemoglobin: 9.0 g/dL

- Serum creatinine: 1.5 × upper limit of normal

- Total bilirubin: 1.5 × ULN

- Aspartate aminotransferase and alanine aminotransferase: 2.5 × ULN (<= 5 × ULN
if liver metastases are present).

- For women of childbearing potential, a negative urine or serum pregnancy test result
before study entry.

- All female and male subjects who are biologically capable of having children must
agree and commit to the use of a reliable method of birth control for the duration of
the study and for 28 days after the last dose of test article. A subject is
biologically capable of having children if he or she is using contraceptives or if
his or her sexual partner is sterile or using contraceptives.

Exclusion Criteria:

- Prior treatment with anthracyclines with a cumulative dose of doxorubicin of >400
mg/m2, or of epirubicin >800 mg/m2, or the equivalent dose for other anthracyclines
or derivatives.

- Major surgery, chemotherapy, radical (curative intent) radiotherapy, investigational
agents, or other cancer therapy within at least 2 weeks before treatment day 1.

- Bone as the only site of disease.

- Active central nervous system metastases, as indicated by clinical symptoms, cerebral
edema, and/or progressive growth. (Subjects with a history of CNS metastases or cord
compression are allowable if they have been definitively treated and are off
anticonvulsants and steroids for at least 4 weeks before cycle 1 day 1) .

- QT (QTc) interval > 0.47 s or a known history of QTc prolongation or Torsades de

- Presence of clinically significant or uncontrolled cardiac disease, including
congestive heart failure (New York Heart Association functional classification of
=2), angina requiring treatment, myocardial infarction within the past 12 months, or
any clinically significant supraventricular arrhythmia or ventricular arrhythmia
requiring treatment or intervention.

- Pregnant or breastfeeding women. Significant chronic or recent acute gastrointestinal
disorder with diarrhea as a major symptom (eg, Crohn disease, malabsorption, or grade
2 diarrhea of any etiology at baseline).

- Inability or unwillingness to swallow tablets (neratinib).

- Preexisting grade 2 or greater motor or sensory neuropathy.

- Subject known to be human immunodeficiency virus seropositive and/or have acute or
chronic hepatitis B infection (hepatitis B surface antigen [HBsAg] positive) or
hepatitis C infection (anti-HCV positive).

- History of known hypersensitivity to vinorelbine and any of its components.

- Any other cancer within 5 years prior to screening with the exception of
contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or
adequately treated basal or squamous cell carcinoma of the skin.

- Clinically significant ongoing or recent infection within 2 weeks before treatment
day 1.

- Evidence of significant medical illness or abnormal laboratory finding that would, in
the investigator's judgment, make the subject inappropriate for this study. Examples
include, but are not limited to, serious active infection (ie, requiring intravenous
antibiotic or antiviral agent) or uncontrolled major seizure.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective is to confirm the safety and tolerability of neratinib in combination with vinorelbine

Outcome Time Frame:

3 weeks

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

July 2009

Completion Date:

April 2010

Related Keywords:

  • Advanced Malignant Solid Tumors
  • HKI-272
  • Vinorelbine
  • Combination
  • Solid Tumor
  • Neoplasms