Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer (NCT01199367) | Clinical Trial Compass
TerminatedPhase 1
Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer
Stopped: The results of the dose escalation phase did not identify a well-tolerated dose that would permit further study in Phase 2.
United States11 participantsStarted 2010-12
Plain-language summary
This study will determine the highest dose of KW-2450 in combination with lapatinib and letrozole that can be administered safely to subjects with advanced or metastatic breast cancer and to evaluate its effectiveness.
This study was terminated in Phase 1 and never proceeded to the Phase 2 portion of the study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histopathologically or cytologically confirmed, advanced or metastatic breast cancer (stage IIIb, IIIc or IV disease) including inflammatory breast cancer or inoperable locally advanced disease.
✓. Measurable or non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria
✓. A life expectancy of \> 3 months for Phase 1 and \> 6 months for Phase 2
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2 at study entry in Phase 1 and ≤ 1 in Phase 2;
✓. Normal cardiac ejection fraction
✓. Adequate hematologic, hepatic and renal function
Exclusion criteria
✕. Type 1 diabetes or uncontrolled Type 2 diabetes
✕. Subjects showing clinical evidence or with a history of cataract(s), proliferate retinopathy or significant macular edema
✕. Subjects with abnormal free T4 values and a history or evidence of thyroid disease
✕. Subjects who are unable or unwilling to take metformin
✕
What they're measuring
1
To establish the safety, tolerability, and recommended Phase 2 dose of KW-2450 administered in combination with lapatinib and letrozole in subjects with previously treated or untreated advanced breast cancer.
✕. Known or suspected human immunodeficiency virus (HIV) infection or hepatitis B or C
✕. Subjects with inflammatory diseases of the gastrointestinal tract
✕. History of other malignancy. Subjects who have been disease free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible;