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GAMMA (Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas)

A Phase 3, Multicenter Randomized, Double-Blind, Placebo Controlled, Trial of AMG 479 or Placebo in Combination with Gemcitabine as First-line Therapy for Metastatic Adenocarcinoma of the Pancreas

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221429
Enrollment
825
Registered
2011-04-11
Start date
2011-04-11
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Metastatic adenocarcinoma of the pancreas

Interventions

Sponsors

Takeda Pharmaceutical Company Limited
Lead Sponsor
Amgen Inc., U.S.A.
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Major inclusion criteria include the following: 1) Untreated metastatic adenocarcinoma of the pancreas 2) Adequate hematologic, renal and liver function 3) Eastern Cooperative Oncology Group (ECOG) performance status : 0 or 1

Exclusion criteria

Exclusion criteria: Major exclusion criteria include the following: 1) Prior chemotherapy or radiotherapy for pancreatic cancer 2) Central nervous system metastases 3) External biliary drain

Design outcomes

Primary

MeasureTime frame
Overall survival

Secondary

MeasureTime frame
Progression free survival, Overall response rate, Adverse events

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026