ST1968 Intravenous (Weekly) in Solid Tumors

NCT01748019 | Completed Phase 1

• 1 other identifier: ST1968-DM-06-001
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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

Solid Tumors

Keywords

ST1968; Camptothecin; Solid tumors; Topoisomerase I

Outcome Measures

Primary Outcomes (1)

• 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

  2/6 patients with a Dose Limiting Toxicity (DLT) at the first cycle (21 days)

  21 days

Secondary Outcomes (3)

• Adverse events, physical examination and laboratory tests (hematology and biochemistry) as a measure of safety and tolerability

  21 days of each cycle of therapy

• Tumor response

  4 weeks

• Tmax, Cmax, AUC0-24, AUC-last, T1/2,CL

  21 days

Study Arms (1)

ST1968

EXPERIMENTAL

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

Drug: ST1968

Interventions

ST1968 DRUG

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

Also known as: Namitecan

ST1968

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• sigma-tau i.f.r. S.p.A.: lead
• Southern Europe New Drug Organization: collaborator

MeSH Terms

Interventions

namitecan

Study Officials

• Dagmar Hess, MD

  Kantonsspital St. Gallen, 9700 St. Gallen - Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: December 12, 2012
• Study Start: June 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 12, 2012

Record last verified: 2012-06