A Study of MLN0264 in Participants With Cancer of the Stomach or Gastroesophageal Junction

Stopped early · Phase 2

Conditions studied: Adenocarcinoma of the Stomach, Gastroesophageal Junction Expressing Guanylyl Cyclase C

In brief

The purpose of this study is to assess the efficacy, safety and tolerability of MLN0264 in patients with recurrent or metastatic guanylyl cyclase C (GCC)-positive adenocarcinoma of the stomach or gastroesophageal junction.

Key facts

Study ID

NCT02202759

Run by

Millennium Pharmaceuticals, Inc.

People needed

38

Starts

2014-08-04

Expected to finish

2016-01-15

Last updated by the study team

2017-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants 18 years of age or older when written informed consent is obtained.
• Histologically confirmed metastatic or advanced inoperable adenocarcinoma of the stomach or gastroesophageal junction with immunohistochemistry (IHC) evidence of guanylyl cyclase C (GCC) expression indicated by an H-score of 10 or greater.
• Treatment with 1 or more prior chemotherapies for advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. All scans and x-rays used to document measurable disease must be done within 28 days before enrollment (ascites and bone lesions are not considered measureable disease).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 14 days before enrollment.
• Female participants who:
• Are postmenopausal for at least 1 year before the screening visit, OR
• Are surgically sterile, OR
• If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or
• Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.)
• Male participants, even if surgically sterilized (ie, status postvasectomy), who:
• Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or
• Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods for the female partner] and withdrawal are not acceptable methods of contraception.)
• Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
• Adequate organ and hematological function as evidenced by the following laboratory values within 14 days before enrollment:
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
• Platelet count ≥ 100 x 10\^9/L
• Hemoglobin ≥ 9 g/dL
• Activated partial thromboplastin time (aPTT) ≤ 1.5 x the upper limit of the normal range (ULN) per institutional laboratory normal range
• International normalized ratio (INR) ≤ 1.5 x ULN
• Serum creatinine ≤ 1.5 x ULN
• Total bilirubin ≤ 1.5 x ULN
• Albumin ≥ 3g/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
• Serum lipase ≤ 3 x ULN and serum amylase within the normal range

You may not qualify if…

• Radiotherapy within 4 weeks before enrollment.
• Concurrent treatment or treatment within 4 weeks of study entry with any other investigational agent or chemotherapy.
• Female participants who are lactating and breastfeeding or have a positive pregnancy test during the Screening period.
• Uncontrolled, clinically significant, symptomatic cardiovascular disease within 6 months before enrollment, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication.
• Treatment with any medication that has a clinically relevant potential risk of prolonging the QT interval or inducing torsades de pointes that cannot be discontinued or switched to a different medication before starting study drug.
• Participants with electrocardiogram (ECG) abnormalities considered by the investigator to be clinically significant, or repeated baseline prolongation of the rate-corrected QT interval (QTc).
• Ongoing or clinically significant active infection as judged by the investigator.
• Signs of peripheral neuropathy (PN) ≥ NCI CTCAE Grade 2.
• Concomitant chemotherapy, hormonal therapy, immunotherapy, or any other form of cancer treatment.
• Use of strong cytochrome P450 (CYP) 3A4 inhibitors within 2 weeks before the first dose of study drug.
• Any preexisting medical condition of sufficient severity to prevent full compliance with the study.
• History of or current neoplasm other than gastric adenocarcinoma, except for curatively treated nonmelanoma skin cancer or in situ carcinoma of the cervix uteri.
• Known diagnosis of human immunodeficiency virus (HIV) infection (testing is not mandatory).
• Symptomatic brain metastases.
• Ongoing anticoagulant therapy (eg, aspirin, coumadin, heparin).

Where it is running

• Study site — Aurora, Colorado, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Boston, Massachusetts, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Nasheville, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Bruges, Belgium
• Study site — Brussels, Belgium
• Study site — Leuven, Belgium
• Study site — Barcelona, Barcelona, Spain
• Study site — Madrid, Madrid, Spain
• Study site — Málaga, Malaga, Spain
• Study site — Seville, Sevilla, Spain
• Study site — London, Greater London, United Kingdom
• Study site — Manchester, Greater Manchester, United Kingdom
• Study site — Sutton, Surrey, United Kingdom

Full record on ClinicalTrials.gov

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