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Clinical Trial VICCPHI1342

Title

A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AMG 337 in Adult Subjects with Advanced Solid Tumors

Principal Investigator(s)

Emily Chan

Details

  • Protocol No. VICCPHI1342
  • Open Date: 02/11/2014
  • Staging: Phase I
  • Age Group: Adults
  • Scope: National
  • Objective: - Evaluate the safety and tolerability of AMG 337. - Characterize the PK of AMG 337 when administered orally as once daily (QD) and twice daily (BID) doses. - Determine the maximum tolerated dose (MTD) of AMG 337 based on the QD dose escalation cohort, if possible.
  • Disease Sites: Phase I
  • Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: AMG 337
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01253707
  • Secondary Protocol No: 20101132

Description

Patients are being asked to take part in this research study because they have an advanced stage solid tumor, with no other standard therapies available that have been shown to improve chances of survival or cure, or patient refusal of these treatments. This research study is investigating AMG 337. This is the first study in which AMG 337 is given to human patients. AMG 337 is an investigational drug which is not approved by the U.S. Food and Drug Administration (FDA) or any government for doctors to prescribe to patients. AMG 337 is a small molecule drug, which is taken by mouth. AMG 337 blocks a receptor called c-Met which is located on cells within the body and tumor. It is hoped that blocking c-Met receptors may help stop tumor spread and growth. In laboratory studies, AMG 337 has been shown to block the c-Met receptor and tumor growth in mice. The purpose of this study is to help to understand whether the AMG 337 study drug can be given safely to humans who have advanced solid tumors. This study will also help determine the best dose or doses of AMG 337 to use in this study and in future studies involving AMG 337.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Men or women ≥ 18 years old
• Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor
• Subjects with primary central nervous system (CNS) tumors or metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible providing they meet all of the following criteria: a) residual neurological symptoms grade ≤ 1; 2) no dexamethasone treatment; and c) follow-up MRI shows no new lesions appearing
• Measurable disease per RECIST guidelines (subjects with non-measurable, but evaluable disease are also eligible for the dose escalation portion of the study)
• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
• Competent to sign and date an Institutional Review Board approved informed consent form
• Adequate hematologic and renal function as determined by laboratory blood and urine tests
Exclusion Criteria:
• Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and continuing for 2 weeks (for women) and 12 weeks (for men) after receiving the last dose of study drug.
• Women who are lactating/breastfeeding or planning to become pregnant during the duration of the study
• History of bleeding diathesis
• Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension
• A baseline ECG QTc > 470 ms
• Active infection requiring (IV) antibiotics within 2 weeks of study enrollment
• Significant gastrointestinal disorder(s), in the opinion of the investigator, that may influence drug absorption
• Known positive test for HIV
• Known acute or chronic hepatitis B or hepatitis C infection as determined by serologic tests
• Anti-tumor therapy within 28 days of study day 1 including chemotherapy, antibody therapy, retinoid therapy, or other investigational agent
• Major surgery within 30 days of study day 1
• Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor