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

Completed · Phase 1/Phase 2

Conditions studied: Breast Cancer, Advanced Malignant Solid Tumors

In brief

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 facts

Study ID

NCT00706030

Run by

Puma Biotechnology, Inc.

People needed

92

Starts

2008-04-29

Expected to finish

2018-06-07

Last updated by the study team

2018-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed pathologic diagnosis of a solid tumor that is not curable with available therapies for which HKI-272 plus vinorelbine is a reasonable treatment option (part 1 only) or Confirmed pathologic diagnosis of ErbB-2-positive breast cancer (current stage IV) in female subjects for which vinorelbine plus HKI-272 is a reasonable treatment option (part 2 only).
• At least 1 prior antineoplastic chemotherapy treatment regimen for metastatic disease and at least 1 prior treatment with a trastuzumab-containing regimen for at least 6 weeks, for metastatic disease or subject relapsing under adjuvant treatment (part 2 only).
• At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST).

You may not qualify if…

• More than 2 prior antineoplastic treatment regimens (excluding hormonotherapy) for metastatic disease. Subjects who relapsed under adjuvant treatment shouldn't have received more than one line of chemotherapy for metastatic disease (part 2 only).
• Prior treatment with vinorelbine for metastatic setting, or prior treatment with any ErbB-2 targeted agents except trastuzumab (part 2 only). Up to 20 subjects with ErbB-2-overexpressing metastatic breast cancer who have been previously exposed to lapatinib but are not refractory to lapatinib may be enrolled in part 2.
• Prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m2, or of epirubicin dose of greater than 800 mg/m2, or the equivalent dose for other anthracyclines or derivatives (part 2 only).

Where it is running

• Highlands Oncology Group — Fayetteville, Arkansas, United States
• City of Hope National Medical Center — Duarte, California, United States
• Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Columbia University Medical Center — New York, New York, United States
• Hematology Oncology Associates of Rockland — Nyack, New York, United States
• Albert Einstein Cancer Center — The Bronx, New York, United States
• Carolinas Hematology-Oncology Associates — Charlotte, North Carolina, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• AZ Klina Brasschaat — Brasschaat, Belgium
• Institut Jules Bordet — Brussels, Belgium
• St.-Augustinus Hospital Oncology Department — Wilrijk, Belgium
• Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China
• The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army — Beijing, Beijing Municipality, China
• Chinese People's Liberation Army General Hospital — Beijing, Beijing Municipality, China
• Tianjin Cancer Hospital — Tianjin, Tianjin Municipality, China
• Centre Paul Papin — Angers, France
• Institut Paoli Calmette — Marseille, France
• Institut Curie, Département d'Oncologie Médicale — Paris, France
• Institut Claudius Regaud — Toulouse, France
• Queen Mary Hospital — Hong Kong, Hong Kong
• UNIMED Medical Institute — Hong Kong, Hong Kong
• Martini Ziekenhuis / Afdeling Interne Geneeskunde — Groningen, Netherlands
• Centrum Onkologii Ziemii Lubelskiej, Oddział Chemioterapii — Lublin, Poland
• Wojskowy Instytut Medyczny, Klinika Onkologii — Warsaw, Poland
• Centro Oncologico de Galicia — A Coruña, Spain

Full record on ClinicalTrials.gov

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