Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Puma Biotechnology, Inc.
Study ID
NCT00706030
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in combination with vinorelbine and to assess the safety of the combination of the two drugs as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors. The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with advanced solid tumors. In the second part of the study, approximately 60 additional subjects with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are planned to be added to better define the tolerability and preliminary activity of HKI-272 in combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory analyses.

Key Dates

Start date
Apr 29, 2008
Status verified
Jun 2018
Primary completion
Oct 31, 2009
Completion
Jun 7, 2018

Study Design

Enrollment
92 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: neratinib 160 mg + vinorelbine
    neratinib 160 mg tablets administered daily by mouth, vinorelbine 25 mg/m\^2 administered IV on day 1 and day 8 of 21 day cycle
  • Experimental: neratinib 240 mg + vinorelbine
    neratinib 240 mg tablets administered daily by mouth, vinorelbine 25 mg/m\^2 administered IV on day 1 and day 8 of 21 day cycle
  • Experimental: neratinib 240 mg + vinorelbine, No Prior Lapatinib
    neratinib 240 mg tablets administered daily by mouth, vinorelbine 25 mg/m\^2 administered IV on day 1 and day 8 of 21 day cycle
  • Experimental: neratinib 240 mg + vinorelbine, Prior Lapatinib
    neratinib 240 mg tablets administered daily by mouth, vinorelbine 25 mg/m\^2 administered IV on day 1 and day 8 of 21 day cycle

Primary Outcome Measure

Overall Response Rate [ Time Frame: From first dose date to progression or last tumor assessment, up to four years and six months. ]

Locations (8)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupFayettevilleArkansas72703-
City of Hope National Medical CenterDuarteCalifornia91010-
Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Columbia University Medical CenterNew YorkNew York10032-
Hematology Oncology Associates of RocklandNyackNew York10960-
Albert Einstein Cancer CenterThe BronxNew York10461-
Carolinas Hematology-Oncology AssociatesCharlotteNorth Carolina28203-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

Find similar trials in Fayetteville, AR

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Highlands Oncology Group· Fayetteville, ARCity of Hope National Medical Center· Duarte, CANorris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center· Lebanon, NHColumbia University Medical Center· New York, NYHematology Oncology Associates of Rockland· Nyack, NYAlbert Einstein Cancer Center· The Bronx, NY

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