Status:
COMPLETED
Study Evaluating Neratinib (HKI-272) In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Breast Cancer
Advanced Malignant Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ob...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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).
Key Trial Info
Start Date :
April 29 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2018
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00706030
Start Date
April 29 2008
End Date
June 7 2018
Last Update
August 9 2018
Active Locations (35)
Enter a location and click search to find clinical trials sorted by distance.
1
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
4
Columbia University Medical Center
New York, New York, United States, 10032