Breast NeoplasmsPhase 1NCT00607841
A Study of Ispinesib in Metastatic Breast Cancer
A Phase 1 study testing Ispinesib in people with Breast Neoplasms, run by Cytokinetics at 3 sites in Peru.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Ispinesib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesPeru
- Study dates
- Dec 2007to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Peru3 sites
Hospital Nacional Alberto Sabogal Sologúren
Lima
Hospital Nacional Edgardo Rebagliati Martins
Lima
Instituto Nacional de Enfermedades Neoplásicas
Lima
About this study
Official title: 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).
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.
Read the detailed description
Only the Phase I portion of the study was enrolled. The Phase I dose-escalation portion of the trial was designed to determine the Dose Limiting Toxicities (DLT) and MTD of Ispinesib (SB-715992) monotherapy when administered as a one-hour infusion on Days 1 and 15 of a 28-day cycle in female patients with locally advanced or metastatic breast cancer. The Phase II regimen was intended to evaluate the MTD determined in Phase I in chemotherapy-naïve female patients with measurable, locally advanced or metastatic breast cancer. Phase II was intended to assess the overall response rate (ORR) derived from individual patient assessments of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) based on RECIST, as determined by independent review.
- Conditions
- Breast Neoplasms
- Being tested
- Ispinesib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IspinesibDrug
Also called SB-715992
10 mg/m2 dose as a 1-hour intravenous infusion.
IspinesibDrug
Also called SB-715992
12 mg/m2 dose as a 1-hour intravenous infusion.
IspinesibDrug
Also called SB-715992
14 mg/m2 dose as a 1-hour intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort 1 | Experimental | Ispinesib given on days 1 and 15 of a 28 day cycle. Receives: Drug: Ispinesib |
| Dose Escalation Cohort 2 | Experimental | Ispinesib given on days 1 and 15 of a 28 day cycle. Receives: Drug: Ispinesib |
| Dose Escalation Cohort 3 | Experimental | Ispinesib given on days 1 and 15 of a 28 day cycle. Receives: Drug: Ispinesib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 28 days
Assessment of response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) in patients with metastatic breast cancer
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Trial stopped for administrative reasons prior to official determination of MTD.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytokinetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew A Wolff, MD, FACC, Study chair, Cytokinetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607841
- Sponsor's protocol ID
- CY 3121
- Status last verified
- May 2019
- First submitted
- 22 Jan 2008
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT00607841
- Acronym / sponsor ID
- CY 3121
- Conditions
- Breast Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial stopped for administrative reasons prior to official determination of MTD.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- CytokineticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Only the Phase I portion of the study was enrolled. The Phase I dose-escalation portion of the trial was designed to determine the Dose Limiting Toxicities (DLT) and MTD of Ispinesib (SB-715992) monotherapy when administered as a one-hour infusion on Days 1 and 15 of a 28-day cycle in female patients with locally advanced or metastatic breast cancer. The Phase II regimen was intended to evaluate the MTD determined in Phase I in chemotherapy-naïve female patients with measurable, locally advanced or metastatic breast cancer. Phase II was intended to assess the overall response rate (ORR) derived from individual patient assessments of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) based on RECIST, as determined by independent review.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort 1 | Experimental | Drug: IspinesibIspinesib given on days 1 and 15 of a 28 day cycle. |
| Dose Escalation Cohort 2 | Experimental | Drug: IspinesibIspinesib given on days 1 and 15 of a 28 day cycle. |
| Dose Escalation Cohort 3 | Experimental | Drug: IspinesibIspinesib given on days 1 and 15 of a 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IspinesibAlso: SB-71599210 mg/m2 dose as a 1-hour intravenous infusion. | Drug | Dose Escalation Cohort 1 |
| IspinesibAlso: SB-71599212 mg/m2 dose as a 1-hour intravenous infusion. | Drug | Dose Escalation Cohort 2 |
| IspinesibAlso: SB-71599214 mg/m2 dose as a 1-hour intravenous infusion. | Drug | Dose Escalation Cohort 3 |
Primary outcome
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
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
Assessment of response rate based on Response Evaluation Criteria in Solid Tumors (RECIST) in patients with metastatic breast cancer
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Trial stopped for administrative reasons prior to official determination of MTD.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew A Wolff, MD, FACC study chair
Cytokinetics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ispinesib in people with Breast Neoplasms, run by Cytokinetics at 3 sites in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Trial stopped for administrative reasons prior to official determination of MTD.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.