Gastrointestinal Cancer
Conditions
Keywords
Gastric Cancer, Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma, AMG 386, Cisplatin, Capecitabine
Brief summary
This is a phase 2, randomized, double blind, placebo controlled, multi-center study to estimate the improvement in progression free survival (compared to control subjects) and evaluate the safety and tolerability of AMG 386 in combination with Cisplatin & Capecitabine in the treatment of subjects with Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma. AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.
Interventions
DRUGAMG 386 placebo
AMG 386 placebo IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
DRUGAMG 386 10mg/kg
AMG 386 10 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
DRUGAMG 386 3mg/kg
AMG 386 3 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
DRUGCisplatin
Cisplatin 80 mg/m2 IV Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
DRUGCapecitabine
Capecitabine1000 mg/m2 PO BID x 14 days Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Disease Related * Histologically or cytologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or distal esophagus with metastatic disease * Measurable or non-measurable disease per RECIST Guidelines * Prior gastrectomy (total or partial) may be allowed as long as subjects can take oral medications and meet all other inclusion/
Exclusion criteria
. Subjects may not take crushed or dissolved capecitabine via a feeding/gastrostomy tube * Palliative radiotherapy for metastatic esophageal or gastric cancer prior to study entry may be allowed as long as all toxicities from radiotherapy have resolved and the radiotherapy was not to the only site of known metastatic disease * Demographic •18 years of age or older at the time the written informed consent is obtained * General * Able to swallow oral medication * ECOG performance status of 0 or 1 * Laboratory * Adequate organ and hematological function as evidenced by laboratory studies prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) | 22 months |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | 22 months |
| Duration of Response (DOR) | 22 months |
| Overall Survival (OS) | 22 months |
| Safety and Tolerability | 22 months |
| Time to Response | 22 months |
| Pharmacokinetics | 22 months |
| Patient Reported Outcomes | 22 months |
| Time to Progression (TTP) | 22 months |
Outcome results
None listed