Advanced/metastatic solid tumors Cancer
Conditions
Interventions
Vial containing 30 mg of powder for solution for infusion. From 12 mg/m² per cycle to the maximum tolerated dose. Intravenous use. Until disease progression or occurrence of unacceptable toxicity.
Sponsors
Institut de Recherche Internationales Servier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients with age = 18 years 2. Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumour in patients for whom no effective standard therapy is available or suitable 3. Elapsed time of 4 weeks or, in absence of toxicity, of 5 half-lives between the completion of the prior antineoplastic therapy including biologic, immunologic or targeted anticancer therapy and S 81694 first administration 4. Elapsed time of 6 weeks for nitrosoureas or mitomycin C 5. Resolution (return to baseline) or return to NCI CTCAE Grade = 1 of all acute toxicities due to prior anticancer therapy except alopecia, grade 2 paraesthesia, grade 2 hyper- or hypothyroidism and other non-clinically significant adverse events 6. ECOG (WHO) performance status 0-1 7. Patient must use effective contraception
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone treatment with high-dose chemotherapy requiring progenitor cell transplantation 2. Episode(s) of clinically relevant active bleeding in the past 3 weeks 3. Known history of haemolytic anaemia (including G6PD deficiency), thrombotic thrombocytopenic purpura (TTP), microangiopathic haemolytic anaemia (MAHA), haemolytic uremic syndrome(HUS) 4. Clinically significant respiratory or metabolic diseases uncontrolled by medication 5. Patients with uncontrolled high blood pressure 6. Presence of risk factors for torsade de pointes (e.g. heart failure, hypokalaemia, family history of long QT syndrome)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose and dose limiting toxicities from the day of the first dose administration in cycle 1 until the date of the first dose administration in cycle 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 19/03/2020: 1. Safety and tolerability profile of S 81694 from the informed consent signature to 30 days after the last treatment administration 2. Determination of the recommended phase II dose 3. Pharmacokinetics profile of S 81694 and its metabolite(s) in plasma and urine during cycle 1 and cycle 2 Previous secondary outcome measures: 1. Safety and tolerability profile of S 81694 from the informed consent signature to 30 days after the last treatment administration 2. Determination of the recommended phase II dose 3. Pharmacokinetics profile of S 81694 and its metabolite(s) in plasma and urine during cycle 1 | — |
Countries
Belgium, Netherlands
Contacts
Public ContactInstitut de Recherches Internationales Servier Clinical Studies Department
Outcome results
None listed