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ST1968 Intravenous (Weekly) in Solid Tumors

NCT01748019 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2012-12-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ST1968

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

Sponsors & Collaborators

  • Southern Europe New Drug Organization

    collaborator OTHER

  • sigma-tau i.f.r. S.p.A.

    lead INDUSTRY

Principal Investigators

  • Dagmar Hess, MD · Kantonsspital St. Gallen, 9700 St. Gallen - Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2011-06-30
Completion
2011-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01748019 on ClinicalTrials.gov