| General information |
| Database: | DB00297 |
| Objective: | This doubleblind, phase 3 study assessed the efficacy and safety of ganitumab combined with gemcitabine as firstline treatment of metastatic pancreatic cancer. |
| Authors: | Fuchs CS, et al |
| Title: | a phase 3 randomized, doubleblind, placebocontrolled trial of ganitumab or placebo in combination with gemcitabine as firstline therapy for metastatic adenocarcinoma of the pancreas: the GAMMA trial. |
| Journal: | Ann Oncol. |
| Year: | 2015 |
| PMID: | 25609246 |
| Trial Design |
| Clinical Trial Id: | NCT01231347 |
| Agent: | ganitumab
|
| Target: | Insulinlike growth factor I receptor
|
| Cancer Type: | pancreatic cancer |
| Cancer Subtype: | advanced pancreatic adenocarcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | ganitumab +gemcitabine |
| Study Type: | a phase III randomized, doubleblind, placebocontrolled trial |
| Key Patients Feature: | Eligible patients (more than and equal to 18 years) had previously untreated histologically or cytologically confirmed metastatic pancreatic adenocarcinoma; ECOG performance status (PS) less than and equal to 1; and adequate hematologic, renal, hepatic, and cardiac function. |
| Biomarker: | circulating total IGF1, IGF2, and IGFbinding protein3 (IGFBP3) and lotheyr IGFBP2 |
| Biomark Analysis: | The circulating biomarkers assessed [insulinlike growth factor1 (IGF1), IGFbinding protein2, and 3] were not associated with a treatment effect on OS or PFS by ganitumab. |
| Control Group Info: | gemcitabine+ placebo(arm A), ganitumab 12 mg/kg(arm B), or ganitumab 20 mg/kg(arm C) |
| Treatment Info: | Patients with previously untreated metastatic pancreatic adenocarcinoma were randomly assigned 2 : 2 : 1 to receive intravenous gemcitabine 1000 mg/m(2) (days 1, 8, and 15 of each 28day cycle) plus placebo, ganitumab 12 mg/kg, or ganitumab 20 mg/kg (days 1 and 15 of each cycle). |
| Primary End Point: | overall survival (OS). |
| Secondary End Point: | progression free survival (PFS), safety, and efficacy by levels of circulating biomarkers. |
| Patients Number: | 800 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Median PFS was 3.7, 3.6 (HR, 1.00; 95% CI, 0.841.20; P = 0.520), and 3.7 months (HR, 0.97; 95% CI, 0.771.22; P = 0.403), respectively. |
| Median OS A vs. C: | 7.2 months [95% confidence interval (CI), 6.38.2] in the placebo arm, 7.0 months (95% CI, 6.28.5) in the ganitumab 12mg/kg arm [hazard ratio (HR), 1.00; 95% CI, 0.821.21; P = 0.494], and 7.1 months (95% CI, 6.48.5) in the ganitumab 20mg/kg arm (HR, 0.97; 95% CI, 0.761.23; P = 0.397). |
| Adverse Event(agent arm): | No unexpected toxicity was observed with ganitumab plus gemcitabine. |
| Conclusions: | Ganitumab combined with gemcitabine had manageable toxicity but did not improve OS, compared with gemcitabine alone in unselected patients with metastatic pancreatic cancer. |