AS703569 and Gemcitabine Combination in Advanced Malignancies

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: AS703569/gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01097512

27902

Details and patient eligibility

About

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).

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Regimen 1: AS703569/gemcitabine

Experimental group

Description:

Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle

Treatment:

Drug: AS703569/gemcitabine

Drug: AS703569/gemcitabine

Regimen 2: AS703569/gemcitabine

Experimental group

Description:

AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle

Treatment:

Drug: AS703569/gemcitabine

Drug: AS703569/gemcitabine