A Study of Ispinesib in Metastatic Breast Cancer

NCT00607841 | Terminated Phase 1

• 1 other identifier: CY 3121
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief Summary

The Phase I portion was a dose-escalation study designed to assess safety and tolerability in patients with metastatic breast cancer. Phase II was intended to measure response rate in patients with metastatic breast cancer but did not enroll because the Phase I portion was halted prior to Maximum Tolerated Dose (MTD) determination.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (3)

• 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

  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

  28 days

• Assessment of response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) in patients with metastatic breast cancer

  28 days

Study Arms (3)

Dose Escalation Cohort 1

EXPERIMENTAL

Ispinesib given on days 1 and 15 of a 28 day cycle.

Drug: Ispinesib

Dose Escalation Cohort 2

EXPERIMENTAL

Ispinesib given on days 1 and 15 of a 28 day cycle.

Drug: Ispinesib

Dose Escalation Cohort 3

EXPERIMENTAL

Ispinesib given on days 1 and 15 of a 28 day cycle.

Drug: Ispinesib

Interventions

Ispinesib DRUG

10 mg/m2 dose as a 1-hour intravenous infusion.

Also known as: SB-715992

Dose Escalation Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytokinetics: lead

Study Sites (3)

Hospital Nacional Alberto Sabogal Sologúren

Lima, Peru

Location

Hospital Nacional Edgardo Rebagliati Martins

Lima, Peru

Location

Instituto Nacional de Enfermedades Neoplásicas

Lima, Peru

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ispinesib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrew A Wolff, MD, FACC

  Cytokinetics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 6, 2008
• Study Start: December 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

PE (3)