Courtney: Did you consult with MD Anderson? Interested in what doctors might think this is a good choice. Also if you did consult at MD, please share what they had to say. You kow I'm in the same boat with you and always interested in new therapies.
Pasting part of a trial that indicates they will accept 20 additional patients in part 2 with prior Tykerb. It looks like you might squeeze in. Not sure about your other antineoplastic drugs.
Let me know if this could work and keep me in your loop.
May the force be with us...Darlene
Study Evaluating HKI-272 in Combination With Vinorelbine in Subjects With Solid Tumors and Metastatic Breast Cancer
This study is currently recruiting participants.
Verified by Wyeth, October 2009
First Received: June 25, 2008 Last Updated: October 7, 2009
History of Changes
Sponsored by:
Wyeth
Information provided by: WyethClinicalTrials.gov Identifier: NCT00706030
Purpose The purposes of this study are to identify the highest tolerable dose of 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.
Condition Intervention Phase Advanced Breast Cancer
Advanced Malignant Solid Tumors
Drug: HKI-272 in combination with vinorelbine
Phase I
Phase II
Study Type:InterventionalStudy Design:Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy StudyOfficial Title:A Phase 1/2 Study of HKI-272 in Combination With Vinorelbine in Subjects With Solid Tumors and Metastatic Breast Cancer
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer Cancer
Drug Information available for:
Vinorelbine Vinorelbine tartrate HKI-272
U.S. FDA Resources
Further study details as provided by Wyeth:
Primary Outcome Measures:
- Physical Exams, Adverse Event Assessment, Tumor Assessments (CT, MRI, bone scan) including independent radiologic review for Part 2 [ Time Frame: 10 months (estimated average participation) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Electrocardiograms (ECGs), QTCLeft Ventricular Ejection Fraction, (LVEF [ Time Frame: 10 months (estimated average participation) ] [ Designated as safety issue: No ]
Estimated Enrollment:95Study Start Date:April 2008Estimated Study Completion Date:January 2011Estimated Primary Completion Date:January 2011 (Final data collection date for primary outcome measure)
Detailed Description: 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 (Tykerb®), 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 (Tykerb®) exposure are also planned to be enrolled in part 2 for exploratory analyses.
Eligibility
Ages Eligible for Study: 18 Years and olderGenders Eligible for Study: BothAccepts Healthy Volunteers: NoCriteria
Inclusion Criteria:
- 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 antineoplasic 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 Criteria:
- More than 2 prior antineoplasic chemotherapy treatment regimens 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).