A Phase II study of oral gimatecan (ST 1481) as salvage treatment in patients with advanced or metastatic soft tissue sarcoma relapsing after anthracycline/ifosfamide-based chemotherapy regime

• Conditions: advanced or metastatic soft tissue sarcoma relapsing after anthracycline/ifosfamide-based chemotherapy regimen; MedDRA version: 8.0Level: HLGTClassification code 10041129

• Registration Number: EUCTR2005-001951-39-DE
• Lead Sponsor: Sigma Tau Industrie Farmaceutiche Riunite S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. Soft Tissue Sarcoma relapsing after anthracyclines and ifosfamide based chemotherapy.
Only the following subtypes of soft tissue sarcoma should be included: Fibrosarcoma
Leiomyosarcoma
Liposarcoma
Malignant fibrous histiocytoma
Rhabdomyosarcoma
Ewing’s Sarcoma of Soft Tissue Synovial sarcoma
Angiosarcoma/hemangiopericytoma
Malignant peripheral nerve sheath tumor (MPNST)
Sarcoma - unclassified
Mesenchymal chondrosarcoma
Extraskeletal myxoid chondrosarcoma (provided that it is metastatic disease which cannot be surgically treated)

2. Patients must have received previous chemotherapy regimens for unresectable advanced or metastatic disease, including anthracyclines and ifosfamide. A maximum of three prior lines is permitted (including adjuvant). Anthracyclines and ifosfamide may have been administered simultaneously or in successive lines of therapy, but the patient should have received both.
3. Clear progressive disease. In case of prior adjuvant therapy progression should have occurred during adjuvant therapy or within 24 months of completion of adjuvant therapy.
4. Age > 18 years.
5. ECOG performance status < 1.
6. Adequate hematological function: hemoglobin > 9 g/dl; neutrophils > 1.5 x 109/L; platelets > 150 x 109/L;
7. LVEF > 50% evaluated by means of ultrasound
8. 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
9. All previous therapies to treat sarcoma must have been discontinued > 4 weeks before study entry and all acute toxicities (excluding alopecia) of any prior therapy must have resolved to CTCAE (Version 3.0) Grade =1.
10. Life expectancy of at least 3 months.
11. 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
12. 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. The following sarcomas are NOT eligible:
- Gastrointestinal stromal sarcoma (GIST)
- Osteosarcoma of soft tissue
- Chondrosarcoma (with the exception of mesenchymal chondrosarcoma and extraskeletal myxoid chondrosarcoma (metastatic disease which cannot be surgically treated)))
- Carcinosarcomas (mixed Mullerian tumors)
- Kaposi sarcoma
- Malignant mesothelioma
- Clear cell sarcoma
2. Prior radiation therapy to > 30% red bone marrow
3. Active infection.
4. Any investigational agent received = 4 weeks prior to study entry and/or concurrent enrolment in another clinical trial.
5. Any prior topotecan- or irinotecan - containing regimen or any regimen containing an investigational inhibitor of topoisomerase I.
6. Prior high dose chemotherapy treatment requiring hematopoietic stem cell rescue.
7. Previous major gastrointestinal surgery or diseases 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).
8. Inability to swallow
9. 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.
10. 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.
11. Previous concomitant malignancy at other site, other than basal or squamous cell carcinoma of the skin or in situ cervical carcinoma within 5 years.
12. Symptomatic brain metastases or leptomeningeal disease requiring therapy.
13. 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