Esophagogastric Junction AdenocarcinomaPhase 1/2NCT00719550
AMG 102 Plus ECX for Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Cancer
A Phase 1/2 study testing Capecitabine, Epirubicin and AMG 102 in people with Esophagogastric Junction Adenocarcinoma and Gastric Cancer, run by Amgen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagogastric Junction Adenocarcinoma, Gastric Cancer, Esophageal Cancer
- What is being tested?
- Capecitabine, Epirubicin and AMG 102
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Jun 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects With Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment With Epirubicin, Cisplatin, and Capecitabine(ECX) Plus AMG 102
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).
- Being tested
- Capecitabine, Epirubicin, AMG 102, Cisplatin, Placebo
- Keywords
- Locally Advanced, Metastatic
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Xeloda
Administered at 625mg/m2 BID orally every day while on study.
EpirubicinDrug
Administered day 1 of each cycle at 50mg/m2 IV.
AMG 102Drug
Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment.
CisplatinDrug
Administered day 1 of each cycle at 60mg/m2 IV.
PlaceboDrug
AMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution
| Study group | Role | What they receive |
|---|---|---|
| Phase 2 Arm C | Placebo comparator | AMG 102 placebo plus ECX Receives: Drug: Capecitabine; Drug: Epirubicin; Drug: Cisplatin; Drug: Placebo |
| Phase 1b | Other | Phase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed. Receives: Drug: Capecitabine; Drug: Epirubicin; Drug: AMG 102; Drug: Cisplatin |
| Phase 2 Arm B | Active comparator | AMG 102 at 7.5mg/kg plus ECX Receives: Drug: Capecitabine; Drug: Epirubicin; Drug: AMG 102; Drug: Cisplatin |
| Phase 2 Arm A | Active comparator | AMG 102 at 15mg/kg plus ECX Receives: Drug: Capecitabine; Drug: Epirubicin; Drug: AMG 102; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS), as measured by RECIST per local review
Measured: 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 outcomes (3)
Overall survival, objective response rate, disease control rate, time to response (for responders only), and duration of response (for responders only).
Measured: 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.
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startFeb 2009
- Primary completionNov 2010
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Esophagogastric Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719550
- Sponsor's protocol ID
- 20060317
- Status last verified
- Nov 2013
- First submitted
- 17 Jul 2008
- Last updated
- 5 Dec 2013
- Results posted
- No
Publications
Doshi S, Loh E, Oliner K, Gisleskog PO, Perez Ruixo JJ, Zhang Y, Zhu M.Exposure survival modeling.Journal-001088;
Iveson T, Donehower RC, Davidenko I, Tjulandin S, Deptala A, Harrison M, Nirni S, Lakshmaiah K, Thomas A, Jiang Y, Zhu M, Tang R, Anderson A, Dubey S, Oliner KS, Loh E. Rilotumumab in combination with epirubicin, cisplatin, and capecitabine as first-line treatment for gastric or oesophagogastric junction adenocarcinoma: an open-label, dose de-escalation phase 1b study and a double-blind, randomised phase 2 study. Lancet Oncol. 2014 Aug;15(9):1007-18. doi: 10.1016/S1470-2045(14)70023-3. Epub 2014 Jun 22.
PubMed 24965569Oliner K.BM Ph2 Gastric.Journal-004521;
TBD.Ph2 Gastric Exposure Response.Journal-004521;
TBD.Ph2 Gastric PRO.Journal-004521;
Zhu.20060317 ER data.Journal-000728;
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects With Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment With Epirubicin, Cisplatin, and Capecitabine(ECX) Plus AMG 102
- ClinicalTrials.gov ID
- NCT00719550
- Acronym / sponsor ID
- 20060317
- Keywords
- Locally Advanced, Metastatic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 2 Arm C | Placebo comparator | Drug: Capecitabine, Drug: Epirubicin, Drug: Cisplatin, Drug: PlaceboAMG 102 placebo plus ECX |
| Phase 1b | Other | Drug: Capecitabine, Drug: Epirubicin, Drug: AMG 102, Drug: CisplatinPhase 1b dose study with open-labe AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed. |
| Phase 2 Arm B | Active comparator | Drug: Capecitabine, Drug: Epirubicin, Drug: AMG 102, Drug: CisplatinAMG 102 at 7.5mg/kg plus ECX |
| Phase 2 Arm A | Active comparator | Drug: Capecitabine, Drug: Epirubicin, Drug: AMG 102, Drug: CisplatinAMG 102 at 15mg/kg plus ECX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: XelodaAdministered at 625mg/m2 BID orally every day while on study. | Drug | Phase 1b, Phase 2 Arm A, Phase 2 Arm B, Phase 2 Arm C |
| EpirubicinAdministered day 1 of each cycle at 50mg/m2 IV. | Drug | Phase 1b, Phase 2 Arm A, Phase 2 Arm B, Phase 2 Arm C |
| AMG 102Investigation product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment. | Drug | Phase 1b, Phase 2 Arm A, Phase 2 Arm B |
| CisplatinAdministered day 1 of each cycle at 60mg/m2 IV. | Drug | Phase 1b, Phase 2 Arm A, Phase 2 Arm B, Phase 2 Arm C |
| PlaceboAMG 102 placebo will be provided in similar vials as clear, colorless, sterile protein-free solution | Drug | Phase 2 Arm C |
Primary outcome
Progression free survival (PFS), as measured by RECIST per local review
Time frame: 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.
3 secondary outcomes
Overall survival, objective response rate, disease control rate, time to response (for responders only), and duration of response (for responders only).
Time frame: 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.
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
- BackgroundDoshi S, Loh E, Oliner K, Gisleskog PO, Perez Ruixo JJ, Zhang Y, Zhu M.Exposure survival modeling.Journal-001088;
- Background: PubMed 24965569Iveson T, Donehower RC, Davidenko I, Tjulandin S, Deptala A, Harrison M, Nirni S, Lakshmaiah K, Thomas A, Jiang Y, Zhu M, Tang R, Anderson A, Dubey S, Oliner KS, Loh E. Rilotumumab in combination with epirubicin, cisplatin, and capecitabine as first-line treatment for gastric or oesophagogastric junction adenocarcinoma: an open-label, dose de-escalation phase 1b study and a double-blind, randomised phase 2 study. Lancet Oncol. 2014 Aug;15(9):1007-18. doi: 10.1016/S1470-2045(14)70023-3. Epub 2014 Jun 22.
- BackgroundOliner K.BM Ph2 Gastric.Journal-004521;
- BackgroundTBD.Ph2 Gastric Exposure Response.Journal-004521;
- BackgroundTBD.Ph2 Gastric PRO.Journal-004521;
- BackgroundZhu.20060317 ER data.Journal-000728;
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Esophagogastric Junction Adenocarcinoma
RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
RecruitingPhase 2
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Stomach Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Capecitabine, Epirubicin and AMG 102 in people with Esophagogastric Junction Adenocarcinoma and Gastric Cancer, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS), as measured by RECIST per local review (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00719550, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2013.