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Phase I Dose Finding and Pharmacokinetic Study of the Intravenous Camptothecin ST1968 in Patients With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

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Trial Information

Phase I Dose Finding and Pharmacokinetic Study of the Intravenous Camptothecin ST1968 in Patients With Solid Tumors


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

21 days

Safety Issue:

Yes

Principal Investigator

Dagmar Hess, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kantonsspital St. Gallen, 9700 St. Gallen - Switzerland

Authority:

Switzerland: Swissmedic

Study ID:

ST1968-DM-06-001

NCT ID:

NCT01748019

Start Date:

June 2007

Completion Date:

December 2011

Related Keywords:

  • Solid Tumors
  • ST1968
  • Camptothecin
  • Solid tumors
  • Topoisomerase I
  • Neoplasms

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