Clinical trial · Interventional

ST1968 Intravenous (Weekly) in Solid Tumors

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

NCT01748019CI-TRIAL-00008658completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Solid Tumors	Solid Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
ST1968	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
ST1968
description
ST1968 once a week for 2 weeks every 3 weeks (protocol amendment: once every 3 weeks \--------------------------------------------------------------------------------
interventionNames
1. Drug: ST1968

Primary outcomes (1)

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

Secondary outcomes (3)

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

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.