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AzTrials

Gastrointestinal CancerPhase 2NCT00583674

Phase 2 Study of AMG 386 (20060439) in Combination With Cisplatin & Capecitabine in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma

A Phase 2 study testing AMG 386 10mg/kg, AMG 386 3mg/kg and Cisplatin in people with Gastrointestinal Cancer, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastrointestinal Cancer
What is being tested?
AMG 386 10mg/kg, AMG 386 3mg/kg and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
171 participants
Where
No sites listed yet
Study dates
Dec 2007to Jun 2012
Phase
Phase 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

  • 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
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  • •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

Who cannot join

  • Disease Related
  • Prior chemotherapy for metastatic disease (1st line)
  • Less than 12 months have elapsed from completion of previous adjuvant or neoadjuvant chemotherapy or chemoradiotherapy
  • Subjects with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy
  • Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities
  • Current or prior history of central nervous system metastases
Show all 29Show fewer
  • History of arterial or deep venous thromboembolism within 12 months prior to randomization
  • History of bleeding diathesis or clinically significant bleeding within 6 months prior to randomization
  • Major surgical procedure within 28 days prior to randomization
  • Minor surgical procedure, placement of central venous access device or fine needle aspiration within 3 days prior to randomization
  • Prior malignancy except: malignancy treated with curative intent and without evidence of active disease for ≥ 3 years prior to randomization and felt to be at low risk for recurrence by treating physician, adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease, adequately treated cervical carcinoma in situ without evidence of disease, prostatic intraepithelial neoplasia without evidence of prostate cancer
  • Prior malignancy (other than in situ cervical cancer, or basal cell cancer of the skin) unless treated with curative intent and without evidence of disease for ≥ 3 years prior to randomization
  • Clinically significant cardiovascular diseases within 12 months prior to randomization
  • Presence of clinically significant non-healing wound, ulcer (including gastrointestinal) or fracture as judged by the investigator
  • Ongoing or clinically significant active infection as judged by the investigator
  • Known hypersensitivity to bacterial proteins, or any of the drugs required in this study
  • Known peripheral neuropathy ≥Grade 1
  • Known dihydropyrimidine dehydrogenase deficiency
  • Known hypersensitivity to 5-FU/capecitabine
  • Known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen
  • Known active or chronic hepatitis
  • Medications
  • Currently or previously treated with angiopoietin inhibitors, or inhibitors of TIE-1 or TIE-2
  • Treatment with immune modulators such as cyclosporine or tacrolimus within 30 days prior to randomization
  • Treatment with sorivudine or its chemically related analogues
  • Anticoagulants (other than aspirin and anti-platelet agents) within 7 days prior to randomization. The concurrent use of low molecular weight heparin or heparanoids or low dose warfarin (i.e, ≤ 1 mg daily) for prophylaxis against thrombosis is acceptable while on study
  • General
  • Not yet completed at least 30 days since ending other investigational device/drug trial(s), or subject is receiving other investigational treatments
  • Pregnant or is breast feeding

About this study

Official title: A Randomized, Double Blind, Multi-Center, Phase 2 Study to Estimate the Efficacy and Evaluate the Safety and Tolerability of Cisplatin & Capecitabine (CX) in Combination With AMG 386 or Placebo in Subjects With Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma

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.

Being tested
AMG 386 placebo, AMG 386 10mg/kg, AMG 386 3mg/kg, Cisplatin, Capecitabine
Keywords
Gastric Cancer, Metastatic Gastric, Gastroesophageal Junction, or Distal Esophageal Adenocarcinoma, AMG 386, Cisplatin, Capecitabine
Medical subject headings
Gastrointestinal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 386 placeboDrug

    AMG 386 placebo IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death

  • AMG 386 10mg/kgDrug

    AMG 386 10 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death

  • AMG 386 3mg/kgDrug

    AMG 386 3 mg/kg IV QW until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death

  • CisplatinDrug

    Cisplatin 80 mg/m2 IV Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death

  • CapecitabineDrug

    Capecitabine1000 mg/m2 PO BID x 14 days Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death

  • CisplatinDrug

    Cisplatin 80 mg/m2 IV Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death

  • CapecitabineDrug

    Capecitabine 1000 mg/m2 PO BID x 14 days Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death

  • CisplatinDrug

    Cisplatin 80 mg/m2 IV Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death

  • CapecitabineDrug

    Capecitabine 1000 mg/m2 PO BID x 14 days Q3W until radiographic disease progression, clinical progression, unacceptable toxicity, subject withdrawal of consent, or death

Study groups in NCT00583674
Study groupRoleWhat they receive
BExperimentalNot described
Receives: Drug: AMG 386 3mg/kg; Drug: Cisplatin; Drug: Capecitabine
AExperimentalNot described
Receives: Drug: AMG 386 10mg/kg; Drug: Cisplatin; Drug: Capecitabine
CActive comparatorNot described
Receives: Drug: AMG 386 placebo; Drug: Cisplatin; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Measured: 22 months

Secondary outcomes (8)

  1. Safety and Tolerability

    Measured: 22 months

  2. Objective Response Rate (ORR)

    Measured: 22 months

  3. Duration of Response (DOR)

    Measured: 22 months

  4. Overall Survival (OS)

    Measured: 22 months

  5. Time to Progression (TTP)

    Measured: 22 months

  6. Time to Response

    Measured: 22 months

  7. Pharmacokinetics

    Measured: 22 months

  8. Patient Reported Outcomes

    Measured: 22 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Dec 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionMar 2010
  4. Study completionJun 2012

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
171 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00583674
Sponsor's protocol ID
20060439
Status last verified
Apr 2014
First submitted
20 Dec 2007
Last updated
7 May 2014
Results posted
No

Publications

  • Eatock MM, Tebbutt NC, Bampton CL, Strickland AH, Valladares-Ayerbes M, Swieboda-Sadlej A, Van Cutsem E, Nanayakkara N, Sun YN, Zhong ZD, Bass MB, Adewoye AH, Bodoky G. Phase II randomized, double-blind, placebo-controlled study of AMG 386 (trebananib) in combination with cisplatin and capecitabine in patients with metastatic gastro-oesophageal cancer. Ann Oncol. 2013 Mar;24(3):710-8. doi: 10.1093/annonc/mds502. Epub 2012 Oct 28.

    PubMed 23108953

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMG 386 10mg/kg, AMG 386 3mg/kg and Cisplatin in people with Gastrointestinal 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 12 inclusion and 29 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 7 May 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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) (time frame: 22 months). 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 NCT00583674, which also lists 1 linked publication.

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 7 May 2014.

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