A randomized, double-blind phase 3 study of gemcitabine plus AG-013736 versus gemcitabine plus placebo for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer

A randomized, double-blind phase 3 study of gemcitabine plus AG-013736 versus gemcitabine plus placebo for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer - Gemcitabine versus AG-013736 with pancreascancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33926

Enrollment

Registered

2007-11-20

Start date

2008-01-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Pancreatic cancer

Interventions

No additional invasive interventions are needed as archived tumor samples, taken in pre-study period, will be used.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection; Adequate coagulation, hepatic and renal function documented within 14 days prior to treatment; Adequate bone marrow function; Male or female, age 18 years or older; ECOG performance status of 0 or 1; Life expectancy of *12 weeks; Resolution of all acute toxic effects of prior therapies, or surgical procedure to NCI CTCAE Grade

Exclusion criteria

Exclusion criteria: Prior treatment with any systemic chemotherapy for metastatic disease; Prior adjuvant chemotherapy or radiotherapy

Design outcomes

Primary

Measure	Time frame
Primary Objective: Compare the overall survival (OS) of patients receiving gemcitabine plus AG-013736 versus gemcitabine plus placebo.	—

Secondary

Measure	Time frame
Secondary Objectives: 1. Compare the progression free survival (PFS) of patients in each arm;2. Compare the objective response rate (ORR) of patients in each arm;3. Estimate the duration of response (DR) of patients in each arm; 4. Evaluate the safety and tolerability of AG-013736 plus gemcitabine; 5.Compare the health-related quality of life (HRQOL), pain ratings, and health status of patients in each arm; 6. Conduct population pharmacokinetic analysis using AG-013736 plasma concentrations.	—

Measure

Time frame

Secondary Objectives: 1. Compare the progression free survival (PFS) of patients in each arm;2. Compare the objective response rate (ORR) of patients in each arm;3. Estimate the duration of response (DR) of patients in each arm; 4. Evaluate the safety and tolerability of AG-013736 plus gemcitabine; 5.Compare the health-related quality of life (HRQOL), pain ratings, and health status of patients in each arm; 6. Conduct population pharmacokinetic analysis using AG-013736 plasma concentrations.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)