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

Phase 1
18 Years
Open (Enrolling)
Advanced Malignancy, Advanced Solid Tumors, Cancer, Oncology, Oncology Patients, Tumors

Thank you

Trial Information

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

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

- Adequate hematologic and renal function as determined by laboratory blood and urine

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 > 480 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

- Concurrent or prior anticoagulation therapy within 7 days of study day 1

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety and tolerability of AMG 337 by reviewing clinically significant or ≥ Grade 3 changes in safety laboratory tests, physical examinations, ECGs, or vitals signs in all subjects enrolled.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

June 2014

Related Keywords:

  • Advanced Malignancy
  • Advanced Solid Tumors
  • Cancer
  • Oncology
  • Oncology Patients
  • Tumors
  • Solid Tumors
  • C-met inhibitor
  • Neoplasms



Research Site Anaheim, California  
Research Site Beverly, Massachusetts  
Research Site Battle Kreek, Michigan  
Research Site Abilene, Texas