- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00607841
A Study of Ispinesib in Metastatic Breast Cancer
A Phase I/II Non-Randomized, Open-Label, Dose-Finding Study of Ispinesib (SB-715992) Followed By a Fixed-Dose Study in Chemotherapy-Naïve Patients With Metastatic Breast Cancer (MBC).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
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Lima, Peru
- Instituto Nacional de Enfermedades Neoplasicas
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Lima, Peru
- Hospital Nacional Edgardo Rebagliati Martins
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Lima, Peru
- Hospital Nacional Alberto Sabogal Sologuren
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically or cytologically confirmed locally advanced (Stage IIIb) or metastatic (Stage IV) adenocarcinoma of the breast. Staging is determined according to the American Joint Committee on Cancer, Cancer Staging Manual, Sixth Edition
Has not received prior cytotoxic chemotherapy for breast cancer and is not currently receiving other anti-cancer therapy, including trastuzumab or other cytostatics, hormonal therapy, radiotherapy, immunotherapy, biologic or investigational agent(s).
Note: Prior therapy does not include (a) previous surgery and/or radiotherapy (if less than 25% of pelvic bone marrow), (b) adjuvant and/or palliative hormonal therapy, (c) gefitinib (Iressa®) or trastuzumab (Herceptin®) given as monotherapy.
- Phase I only: Patients who have previously received anthracycline therapy in either the adjuvant or neoadjuvant setting may participate, provided a minimum of one year has elapsed since last treatment.
- Phase I only: Must have evaluable, but not necessarily measurable disease by imaging.
- Phase II only: Must have at least one unidimensionally measurable lesion evaluable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The lesion(s) must be documented by photography, radiography, direct measurement, or palpation.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- Female patients, 18 years of age or older.
A female is eligible to enter and participate in the study if she is of:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who:
- Has had a hysterectomy,
- Has had a bilateral oophorectomy (ovariectomy),
- Has had a bilateral tubal ligation, or
- Is post-menopausal (a demonstration of total cessation of menses for ≥ 1 year.
Childbearing potential, has a negative serum pregnancy test at screening, and agrees to one of the following:
- Intrauterine Device (IUD),
- Vasectomized partner who is sterile prior to the female patient's entry and is the sole sexual partner for that female,
- Complete abstinence from sexual intercourse for two weeks before exposure to investigational product, throughout the clinical trial, and for at least one week after the last dose of investigational product, or
- Double barrier contraception (condom with spermicidal jelly, foam, suppository, or film, diaphragm with spermicide, or male condom and diaphragm).
- Progesterone based contraceptive with a failure rate of < 1%.
- A signed and dated written informed consent is obtained from the patient or the patient's legally acceptable representative prior to screening.
Exclusion Criteria:
- Receipt of prior cytotoxic chemotherapy except in an adjuvant or neo adjuvant setting
- Has not recovered from prior therapy including any major surgery, radiotherapy, immunotherapy, biologic or investigational agent(s).
- Absolute neutrophil count (ANC) <1,500/mm3.
- Platelets < 100,000/mm3.
- Creatinine clearance ≤ 40 mL/min as calculated by the Cockcroft-Gault Formula.
- Total bilirubin greater than or equal to 1.5 x ULN
- Alanine aminotransferase (ALT) greater than 2 times the upper limit of normal (ULN) in the absence of liver metastases (patients with serum transaminase levels up to 5 times ULN in the presence of liver metastases may be enrolled following approval by Cytokinetics Medical Monitor).
- Alkaline Phosphate (ALP) greater than or equal to 5 x ULN
- Female patients who are pregnant or lactating.
- Women of reproductive potential who do not agree to use an effective contraceptive method.
- Any unstable, pre-existing major medical condition or history of other malignancies (except excised cervical or basal skin/squamous cell carcinoma).
- Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol.
- Evidence of central nervous system (CNS) metastases or leptomeningeal disease
- Evidence of any other malignancy
- Previous exposure to any Investigational Agent
- Radiation therapy within 28 days, or within 3 months if blood urea nitrogen (BUN) is ≥20mg/dl
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Escalation Cohort 1
Ispinesib given on days 1 and 15 of a 28 day cycle.
|
10 mg/m2 dose as a 1-hour intravenous infusion.
Other Names:
12 mg/m2 dose as a 1-hour intravenous infusion.
Other Names:
14 mg/m2 dose as a 1-hour intravenous infusion.
Other Names:
|
Experimental: Dose Escalation Cohort 2
Ispinesib given on days 1 and 15 of a 28 day cycle.
|
10 mg/m2 dose as a 1-hour intravenous infusion.
Other Names:
12 mg/m2 dose as a 1-hour intravenous infusion.
Other Names:
14 mg/m2 dose as a 1-hour intravenous infusion.
Other Names:
|
Experimental: Dose Escalation Cohort 3
Ispinesib given on days 1 and 15 of a 28 day cycle.
|
10 mg/m2 dose as a 1-hour intravenous infusion.
Other Names:
12 mg/m2 dose as a 1-hour intravenous infusion.
Other Names:
14 mg/m2 dose as a 1-hour intravenous infusion.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose Limiting Toxicity and Maximum Tolerated Dose of ispinesib administered as a 1-hr intravenous infusion on Day 1 of a 28-day cycle in female patients with Stage IIIB or IV breast cancer
Time Frame: 28 days
|
28 days
|
Dose Limiting Toxicity and Maximum Tolerated Dose of ispinesib administered as a 1-hr intravenous infusion on Day 15 of a 28-day cycle in female patients with Stage IIIB or IV breast cancer
Time Frame: 28 days
|
28 days
|
Assessment of response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) in patients with metastatic breast cancer
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Andrew A Wolff, MD, FACC, Cytokinetics
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CY 3121
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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