A Phase I/II Non-Randomized, Open-Label, Dose-Finding Study of Ispinesib (SB-715992) Followed By a Fixed-Dose Study in Chemotherapy-Naive Patients With Metastatic Breast Cancer (MBC).

Cytokinetics, Inc.,0 个研究点目标入组 0 人开始时间: 2007年11月15日最近更新: 2023年9月4日

适应症

试验速览

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•1. If a locally advanced or metastatic breast adenocarcinoma is confirmed, histologically or mythologically.
•2. If patients have not received prior cytotoxic chemotherapy for breast cancer and are not currently receiving another anticancer therapy.
•3. Phase I only: Patients who have previously received therapy with anthracycline and another adjuvant or neoadjuvant may participate, provided a minimum of 1 year has elapsed since their last treatment.
•4. Phase I only: Must have had a measurable disease but not necessarily measurable.
•5. Phase II only: Must have had at least one one-dimensionally measurable lesion, evaluable according to RECIST criteria.
•6. ECOG performance status of 0-1.
•7. Female patients 18 years of age or older.
•8. A woman is eligible to enter and participate in the study if: a) She is not prone to pregnancy. OR b) If you are in the stage of possible pregnancy and have a negative pregnancy test and are willing to use an acceptable method of contraception.
•9. The patient or his legal representative will sign and date an informed consent before the pre-selection.

•1. If the patient has received prior cytotoxic chemotherapy.
•2. If the patient has not recovered from previous therapy.
•3. Absolute neutrophil count (ANC) <1,500 / mm3.
•4. Platelets <100,000 / mm3.
•5. Creatinine clearance ≤ 40 ml / min.
•6. Total bilirubin much greater than or equal to 1.5 x ULN
•7. Alanine aminotransferase (ALT) greater than 2 times the upper normal limit (ULN) with absence of liver metastasis.
•8. Alkaline Phosphatase (ALP) greater than or equal to 5 x ULN.
•9. Female patients who are pregnant or nursing.
•10. Potentially reproductive women who do not agree with the use of an effective contraceptive method.
•11. Any pre-existing unstable major medical condition or history of other ailments.
•12. Psychological, family, sociological or geographical condition that does not allow compliance with the study protocol.
•13. Evidence of metastasis in the central nervous system or leptomeningeal disease.
•14. Evidence of any other disease
•15. Previous exposure to any other investigative agent.
•16. Radiation therapy within 28 days or 3 months if the BUN is ≥ 20 mg / dl..

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