Clinical trial · Interventional
AS703569 and Gemcitabine Combination in Advanced Malignancies
A Phase I, Dose-escalation Study of a Combination AS703569 and Gemcitabine Given to Subjects With Advanced Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In clinical practice and research, combination of anticancer agents is often used to improve efficacy of treatment. In vitro and in vivo experiments have shown additive-synergistic anti-tumour effects of AS703569 treatment when combined with gemcitabine. Specifically, additive-synergistic anti-tumour effects were noticed when the two agents were given sequentially and not concomitantly i.e. AS703569 given the day before or the day after gemcitabine. This trial was designed to investigate in parallel two regimens testing sequential administration of AS703569 either the day after gemcitabine infusion, (Regimen 1) or the day before (Regimen 2).
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AS703569/gemcitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regimen 1: AS703569/gemcitabine
- description
- Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle
- interventionNames
- Drug: AS703569/gemcitabine
- type
- EXPERIMENTAL
- label
- Regimen 2: AS703569/gemcitabine
- description
- AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle
- interventionNames
- Drug: AS703569/gemcitabine
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- 21 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Histologically/cytologically confirmed diagnosis of measurable or assessable malignancy, who meets one of the following conditions: Subject with a tumour for which gemcitabine is approved, Subject with a tumour for which gemcitabine is considered standard of care, Subject with other tumour type either refractory or intolerant to or for whom there is not an accepted standard treatment. Male or female with at least 18 years of age. Life expectancy of at least 3 months. Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2. No more than 3 prior chemotherapy regimens for advanced/metastatic disease. At least 4 weeks since last chemotherapy, hormonal therapy, immunotherapy, biological or any other pharmacological or investigational treatment or radiotherapy (6 weeks wash-out for nitrosoureas and mitomycin C, 5 half-lives for non-cytotoxics). Subjects on chronic hormonal therapy may continue with the same treatment unchanged. Adequate renal, hepatic and bone marrow functions (assessed 7 days before inclusion in the trial) as defined by: Serum creatinine
References
Publications (1)
- RESULTRaymond E, Alexandre J, Faivre S, Goldwasser F, Besse-Hammer T, Gianella-Borradori A, Jego V, Trandafir L, Rejeb N, Awada A. A phase I schedule dependency study of the aurora kinase inhibitor MSC1992371A in combination with gemcitabine in patients with solid tumors. Invest New Drugs. 2014 Feb;32(1):94-103. doi: 10.1007/s10637-013-9950-y. Epub 2013 Mar 29. PMID 23539344