Esophagogastric Junction Adenocarcinoma, Gastric Cancer, Esophageal Cancer
Conditions
Keywords
Locally Advanced, Metastatic
Brief summary
Study Phase: 1b/2 Indication: Previously untreated subjects with unresectable locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma. Primary Objective(s): Part 1: To identify safe dose levels of AMG 102, up to 15 mg/kg Q3W, to combine with ECX. Part 2 (phase 2-double-blind): To estimate with pre-specified precision the effect of the addition of AMG 102 to ECX on progression free survival (PFS).
Interventions
DRUGCapecitabine
Administered at 625mg/m2 BID orally every day while on study.
DRUGEpirubicin
Administered day 1 of each cycle at 50mg/m2 IV.
DRUGAMG 102
Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
DRUGCisplatin
Administered day 1 of each cycle at 60mg/m2 IV.
DRUGPlacebo
AMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed unresectable locally advanced or metastatic gastric or esophagogastric junction (EGJ) adenocarcinoma; tumors of the distal esophagus within 5 cm of the EGJ are eligible * ECOG performance status 0 or 1 * Male or female ≥ 18 years of age
Exclusion criteria
* Previous systemic therapy (chemotherapy or biologic therapy) for locally advanced or metastatic gastric or esophagogastric adenocarcinoma * Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy. * Subjects with resectable disease or suitable for definitive chemoradiation * Subjects with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy * Tumors of squamous cell histology * Known central nervous system metastases * Clinically significant upper gastro-intestinal bleeding ≤ 30 days prior to enrollment or randomization * Serious or non-healing wound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS), as measured by RECIST per local review | Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study. |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, objective response rate, disease control rate, time to response (for responders only), and duration of response (for responders only). | Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study. |
| Incidence of adverse events, significant laboratory value changes form baseline and anti-AMG 102 antibody formation. | Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study. |
| Cmax and Cmin for AMG 102; Cmax and AUC for epirubicin and cisplatin with or without AMG 102 | Subjects coming off study will be contacted by telephone or at routine clinic visits approximately every 3 months until 36 months from date the last subject is randomized into the study. |
Outcome results
None listed