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

NCT ID: NCT00583674

Last Updated: 2014-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2012-06-30

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.

Conditions

Gastrointestinal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

B

Group Type: EXPERIMENTAL

AMG 386 3mg/kg

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

Capecitabine

Intervention Type: DRUG

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

A

Group Type: EXPERIMENTAL

AMG 386 10mg/kg

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

Capecitabine

Intervention Type: DRUG

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

C

Group Type: ACTIVE_COMPARATOR

AMG 386 placebo

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

Capecitabine

Intervention Type: DRUG

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

Interventions

AMG 386 placebo

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

Intervention Type: DRUG

AMG 386 10mg/kg

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

Intervention Type: DRUG

AMG 386 3mg/kg

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

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Capecitabine

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

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Capecitabine

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

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Capecitabine

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

Intervention Type: DRUG

Eligibility Criteria

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

Exclusion Criteria

• 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

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

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.

Reference Type: BACKGROUND

PMID: 23108953 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20060439

Identifier Type: -

Identifier Source: org_study_id