None listed
Conditions
Interventions
PHASE I. GROUP 1 Type of group
1 N° of participants:≥
This group will be treated with Ispinesib, at a dose of 10 mg / m2, in an IV infusion for 1 hour, on days 1 and 15 of a 28-day cycle. The therapy in the following groups will depend on the tolerance that develops in this one.
Group name:PHASE II Type of group
This phase, is composed of 3 states:
State I: 19 patients will start with Ispinesib, at the optimal dose established in phase I, during a cycle of 28 days or until the disease progresses. It will go to the next state if 1 or more answers are confirmed.
State II: 45 patients will start with Ispinesib, at the optimal dose established in phase I, during a cycle of 28 days or until the disease progresses. It will go to the next state if 8 or more answers are confirmed.
State III: 45 new pat
Sponsors
Cytokinetics, Inc.,
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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..
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Appearance of any toxicity related to the drug greater than or equal to grade 3, in the following body systems: a) Non-haematological toxicity. b) Nausea / vomiting / diarrhea Grade 3 that persists beyond 10 days of uncontrolled dosing with aggressive treatment. c) Granulocytopenia Grade 4 lasting 5 days or more without support of hematopoietic growth factor or febrile neutropenia grade 3. d) Thrombocytopenia Grade 4. e) Grade 4 anemia that lasts more than 7 days and not due to haemorrhage or diffuse infiltration of bone marrow. f) Non-haematological toxicity greater than or equal to 2 degrees that persists beyond Cycle 1. g) Grade 2 toxicity of which the investigator considers is a limiting dose. Measure:Phase I: Limiting Toxicity of Dose or Maximum Tolerated Dose (MTD). Timepoints:At the end of Phase I. ; Outcome name:The ORR is based on the complete response (CR), partial response (PR), disease stability (SD) or disease progression (PD) based on the RECIST criterion. CR is defined as the disappearance of all target lesions. Or the disappearance of all non-target lesions and level normalization in tumor markers. PR is defined as a reduction of at least 30% of the sum of the largest diameters of the target lesions. SD is defined as that case that does not have criteria to be classified as PR or PD. PD is defined as an increase of at least 20% in the sum of the largest diameters of the target lesions. Or the appearance of one or more new lesions and / or equivocal advance of existing non-objective lesions. Measure:Phase II: Total Response Index (ORR). Timepoints:At the end of Phase II | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criterion 1: Time between the first dose of the study drug and the first documented or complete partial response (defined above). Criterion 2: Time from the date of the initial response until the date of the progression of the disease (defined above). Criterion 3: Time from the date of the first dose of the study drug to the date of disease progression (defined above). Measure:1) Response time. 2) Duration of the response. 3) Time of the progression. Timepoints:When the event is presented. ; Outcome name:Criterion 1: Clinical evaluation of any unfavorable medical occurrence in a patient to whom the research drug is administered Criterion 2: Measurement of temperature, heart rate, respiratory rate and blood pressure. Criterion 3: Parameters of serum chemistry and hematology. Measure:Safety and tolerability: 1) Adverse events. 2) Vital signs. 3) Laboratory parameters. Timepoints:Criterion 1: Days 1 and 15 of each cycle. Criterion 2: Day 1 of each cycle. Criterion 3: Days 1, 8, 15 and 22 of each cycle. ; Outcome name:Determination of the Debug (Cl) and the volume of distribution (Vd). Measure:Pharmacokinetics. Timepoints:Days 1 and 15 of the first cycle and days 1 of later cycles. | — |
Countries
Peru
Contacts
Public ContactElizabeth Rospigliosi
I3 LATIN AMERICA PERU S.A.
Outcome results
None listed