Phase I study of oral administration of S 78454 in association with doxorubicin in patients with solid tumour

Phase I dose-escalation study of oral administration of S 78454 given with a fixed dose infusion of doxorubicin administered weekly 3 out of 4 weeks in patients with solid tumour

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN55052510

Enrollment

Registered

2013-09-24

Start date

2010-11-15

Completion date

Unknown

Last updated

2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumours Cancer Malignant neoplasm, unspecified

Interventions

1. Capsules containing 20 mg and 100 mg of S 78454 / Oral use / Treatment duration is 6 cycles 2. Fixed dose infusion of 25 mg/m² of doxorubicin, weekly 3 out of 4 weeks / Treatment duration is 6 cycl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Solid tumour, with measurable or evaluable disease, that has relapsed or is refractory to conventional, standard forms of therapy 2. Ability to swallow oral capsule(s) without difficulty 3. Estimated life expectancy > 12 weeks 4. Eastern Cooperative Oncology Group (ECOG) performance status < or equal to 1 5. Adequate haematological, renal and hepatic functions

Exclusion criteria

Exclusion criteria: 1. Major surgery within previous 4 weeks 2. Chemotherapy within previous 3 weeks (6 weeks in case of nitrosoureas) 3. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions) 4. Immunotherapy or hormonotherapy within previous 2 weeks, except stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency, or oral contraceptives or hormonal replacement therapy 5. Risk factors for, or use of drugs known to prolong QTc interval and that may be associated with Torsades de Pointes 6. Patients treated by valproic acid within previous 5 days 7. Phenytoin (and by extension fosphenytoin) within previous 3 weeks

Design outcomes

Primary

Measure	Time frame
1. Dose-limiting toxicities (DLTs) and maximum tolerated doses (MTDs) at each visit - Methods used: blood samples, physical examination, electrocardiogram (ECG) 2. Safety profile of the combination at each visit	—

Secondary

Measure	Time frame
1. Tumour response at baseline evaluation every 2 cycles using the Response Evaluation Criteria In Solid Tumors (RECIST) guideline 2. Pharmacokinetic parameters during cycle 1 and 2 by blood samples 3. Pharmacodynamic parameters during cycle1 by blood samples and tumour biopsies	—

Countries

Belgium, France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026