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ST1968 Intravenous (Weekly) in Solid Tumors

This study has been completed.
Southern Europe New Drug Organization
Information provided by (Responsible Party):
sigma-tau i.f.r. S.p.A. Identifier:
First received: June 12, 2012
Last updated: December 10, 2012
Last verified: June 2012
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.

Condition Intervention Phase
Solid Tumors Drug: ST1968 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Dose Finding and Pharmacokinetic Study of the Intravenous Camptothecin ST1968 in Patients With Solid Tumors

Further study details as provided by sigma-tau i.f.r. S.p.A.:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of ST1968 given I.V. once every week for 2 consecutive weeks every 3 weeks and MTD of ST1968 given I.V. once every 3 weeks [ Time Frame: 21 days ]
    2/6 patients with a Dose Limiting Toxicity (DLT) at the first cycle (21 days)

Secondary Outcome Measures:
  • Adverse events, physical examination and laboratory tests (hematology and biochemistry) as a measure of safety and tolerability [ Time Frame: 21 days of each cycle of therapy ]
    safety assessments (routine physical examinations and laboratory evaluations) and severity of adverse events based on the NCI-Common Terminology Criteria for Adverse Events V. 3.0 (NCI-CTCAE)

  • Tumor response [ Time Frame: 4 weeks ]
    objective tumor response based on RECIST criteria

  • Tmax, Cmax, AUC0-24, AUC-last, T1/2,CL [ Time Frame: 21 days ]
    full blood and urine PK

Enrollment: 62
Study Start Date: June 2007
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ST1968

ST1968 once a week for 2 weeks every 3 weeks (protocol amendment: once every 3 weeks

Drug: ST1968
ST1968 once a week for 2 weeks every 3 weeks (protocol amendment: once every 3 weeks
Other Name: Namitecan

Detailed Description:

Multicenter, open label, uncontrolled Phase I pharmacokinetic trial to determine the Maximum Tolerated Dose (MTD) of ST1968 given intravenously (I.V.) once every week for 2 consecutive weeks every 3 weeks and the MTD of ST1968 given I.V. once every 3 weeks. A starting dose of 1.5mg/m2 given as a flat dose of 2.5mg is defined, given once on Day 1, Day 8 every 21 Days (D1, D8 Q21D schedule), over 2 h. Starting dose for the Day 1 every 21 Days (D1 Q21D schedule) has to be determined from the MTD of D1, D8 Q21D schedule.

Plasma, urine pharmacokinetics in all patients (minimum of 3 pts for each cohort) during the first cycle of treatment and in at least 6 patients at the Recommended Dose (RD).

During the study any hints of anti-tumor activity will also be evaluated by RECIST criteria.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01748019

Sponsors and Collaborators
sigma-tau i.f.r. S.p.A.
Southern Europe New Drug Organization
Study Chair: Dagmar Hess, MD Kantonsspital St. Gallen, 9700 St. Gallen - Switzerland
  More Information

Responsible Party: sigma-tau i.f.r. S.p.A. Identifier: NCT01748019     History of Changes
Other Study ID Numbers: ST1968-DM-06-001
Study First Received: June 12, 2012
Last Updated: December 10, 2012

Keywords provided by sigma-tau i.f.r. S.p.A.:
Solid tumors
Topoisomerase I

Additional relevant MeSH terms:
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 17, 2017