Status:
TERMINATED
Safety, Tolerability, and Efficacy Study in Subjects With Advanced or Metastatic Breast Cancer
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Collaborating Sponsors:
Kyowa Hakko Kirin Pharma, Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
This open-label, sequential, ascending, multi-dose, Phase 1/2 study will enroll up to 198 post-menopausal subjects with advanced or metastatic breast cancer whose tumors overexpress HER2. Subjects at ...
Eligibility Criteria
Inclusion
- 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.
- Documented ErbB2 overexpression
- Estrogen receptor positive (ER+) and/or progesterone positive (PgR+) tumors
- 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
- Post-menopausal female (defined as the absence of a menstrual cycle for at least 12 consecutive months) or male subjects ≥ 18 years of age.
- Sign an IRB or EC approved informed consent
- 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
- Uncontrolled intercurrent illness
- 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;
- Subjects with extensive symptomatic visceral disease including hepatic involvement and pulmonary lymphangitic spread of tumor
- A history of prior treatment with other agents specifically targeting IGFRs
- Subjects who require pharmacological doses of glucocorticoids beyond replacement doses. The use of topical, intra-ocular or inhalation glucocorticoids is permitted
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01199367
Start Date
December 1 2010
End Date
December 1 2012
Last Update
April 25 2024
Active Locations (5)
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1
Breastlink Research Group
Long Beach, California, United States, 90250
2
Associates in Hematology-Oncology
Los Angeles, California, United States, 90057
3
Sylvester Comprehensive Cancer Center
Deerfield Beach, Florida, United States, 33136
4
Clinical Oncology Associates
Farmington Hills, Michigan, United States, 48336