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A Phase I, Dose-escalation Study of a Combination AS703569 and Gemcitabine Given to Subjects With Advanced Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

A Phase I, Dose-escalation Study of a Combination AS703569 and Gemcitabine Given to Subjects With Advanced Malignancies


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD)

Outcome Description:

To determine the maximum tolerated dose (MTD) during a 21-day cycle, for each of the two planned regimens using combination therapy with AS703569 and gemcitabine.

Outcome Time Frame:

21 days

Safety Issue:

No

Principal Investigator

Narmyn Rejeb, MD

Investigator Role:

Study Director

Investigator Affiliation:

Merck Serono S.A., Geneva

Authority:

Belgium: Institutional Review Board

Study ID:

27902

NCT ID:

NCT01097512

Start Date:

June 2007

Completion Date:

February 2011

Related Keywords:

  • Pancreatic Cancer
  • AS703569
  • Aurora kinase inhibitor
  • Cancer treatable with gemcitabine
  • Pancreatic Neoplasms

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