Phase II study of gimatecan (ST 1481) as salvage treatment in patients with advanced breast cancer after anthracycline /taxanes-based chemotherapy regime

• Conditions: advanced breast cancer; Level: LLTClassification code 10006285

• Registration Number: EUCTR2004-005106-79-ES
• Lead Sponsor: Sigma Tau industrie Farmaceutiche Riunite Spa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-04
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

1.Women with histologically/cytologically confirmed diagnosis of primary breast cancer
2.Presence of locally advanced to metastatic disease non-amenable to surgery or radiation therapy with curative intent
3.A maximum of 2 prior chemotherapies (which must have included previous treatment with anthracyclines and taxanes) for advanced disease (3 in case of a prior adjuvant chemotherapy).
4.At least one measurable (target) lesion according to RECIST criteria. Previously irradiated lesions will not be considered as target lesions.
5.Age > 18 years and < 75 years
6.ECOG performance status < 1.
7.Adequate hematological function: hemoglobin > 9 g/dl; neutrophils > 1.5 x 109/L; platelets > 150 x 109/L;
8.LVEF > 50% (or according to UNL of the Center) evaluated by means of ultrasound
9.Adequate liver and renal function
-alkaline phosphatase ? 1.5 x UNL, if bone metastases present, hepatic isoenzyme should be <1.5 UNL
-total serum bilirubin ? 1.5 times UNL regardless of liver involvement secondary to tumor
-ALT, AST ? 1.5 x UNL (? 2.5 x UNL in presence of liver metastases)
-albumin > 2.5 g/dl
-creatinine ? 1.5mg/dL or 133 ?mol/l
10.All previous therapies, including hormones, must have been discontinued > 4 weeks before study entry and all acute toxicities (excluding alopecia) of any prior therapy must have resolved to NCI-CTC (Version 2.0) Grade =1.
11.Life expectancy of at least 3 months.
12.Evidence of a signed and dated informed consent document indicating the patient (or legally acceptable representative) has been informed of all pertinent aspects of the study
13.Willingness and ability to comply with the study protocol for the duration of the trial.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Prior radiation therapy to > 30% bone marrow
2.Active infection.
3.Any investigational agent received = 4 weeks prior to study entry and/or concurrent enrolment in another clinical trial .
4. Prior high dose chemotherapy treatment requiring hematopoietic stem cell rescue.
5.Previous major gastrointestinal surgery that could alter absorption or motility (i.e. active peptic ulcer, inflammatory bowel disease, known intolerance to lactose, malabsorption syndromes, intestinal sub-occlusion or previous major gastrointestinal surgery).
6.Inability to swallow
7.Presence of serious cardiac (congestive heart failure, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorder.
8.Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
9.Previous concomitant malignancy at other site, other than basal or squamous cell carcinoma of the skin or in situ cervical carcinoma within 5 years.
10.Symptomatic brain metastases or leptomeningeal disease requiring therapy.
11.Pregnancy or lactation or unwillingness to use adequate method of birth control

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary<br>To assess the antitumor activity of single agent gimatecan given orally on a 5 days on, 2 days off schedule for 2 weeks every 28 days as salvage treatment in female patients with advanced, breast cancer who have failed anthracycline /taxanes-based chemotherapy.<br>;Secondary Objective: Secondary<br>?To define the safety profile of gimatecan therapy given 5 days on, 2 days off schedule for 2 weeks every 28 days <br>?To define the tolerability of a 5 days on, 2 days off schedule for 2 weeks every 28 days <br>?To determine the time to progression (TTP)<br>?To evaluate plasma pharmacokinetics of gimatecan treatment in participating centers<br>;Primary end point(s): The primary endpoint of the study is the objective response rate measured according to RECIST criteria induced by gimatecan, administered orally for 5 days on 2 days off schedule for 2 weeks every 28 days.