ST1968 Intravenous (Weekly) in Solid Tumors

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

ST1968 is a novel camptothecin derivative which interacts with topoisomerase I-DNA complex, inducing S-Phase specific cytotoxicity. It is endowed with a potent antitumor activity and an increased Therapeutic Index with respect to the clinically used analogues (i.e.irinotecan and topotecan) in some xenograft models (ovary, colon, head & neck, cervix). Anti-tumor activity has been also noted in platinum resistant ovarian cell xenografts and in topoisomerase I mutant prostate cell lines. The acceptable toxicity profile in animals and the activity in camptothecin-resistant cell lines make ST1968 a good candidate for clinical trials.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: sigma-tau i.f.r. S.p.A.
• Collaborator: Southern Europe New Drug Organization
• Treatments: Camptothecin; Namitecan

Criteria

Inclusion Criteria:

• Histological/cytological diagnosis of solid tumors for which therapy of proven efficacy does not exist.

• Preferably measurable disease

• ECOG performance status ≤ 1.

• Age ≥ 18 years.

• Ongoing toxicity associated with prior anticancer therapy ≤ grade 1 (NCI-CTCAE V3.0).

• Maximum of 2 prior chemotherapy lines for advanced disease (not including neoadjuvant or adjuvant chemotherapy)

• Adequate hematological, liver and renal function

• Hemoglobin ≥ 9 g/dl; ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L;

• Serum bilirubin ≤ upper normal limit (UNL). ALT, AST ≤ UNL but ≤ 2.5 x UNL in case of liver metastases; alkaline phosphatase (liver isoenzyme fraction) ≤ UNL or ≤ 1.5xULN in case of liver metastases; albumin within normal limits;

• Creatinine ≤1.5 mg/dl or calculated creatinine clearance ≥ 60 ml/min.

• Life expectancy of at least 3 months

• Capacity of understanding the nature of the trial and giving written informed consent.

Exclusion Criteria:

• Less than 4 weeks since last chemotherapy, radiotherapy or prior investigational therapy. Less than 2 weeks since last hormone or immunotherapy or signal transduction therapy.

• Active infection.

• Presence of cirrhosis or chronic hepatitis

• 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.

• 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.

• Symptomatic brain metastases (this does not include primary brain tumors) or leptomeningeal disease.

• Pregnancy or lactation or unwillingness to use adequate method of birth control