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A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 208 in Adult Subjects With Advanced Solid Tumors

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

Thank you

Trial Information

A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 208 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 that is refractory to standard treatment, for which no standard therapy
is available or the subject refuses standard therapy

- Measurable disease per RECIST guidelines (subjects with non-measurable, but evaluable
disease are also eligible for Part 1 of the study)

- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2

- Life expectancy of > 3 months, in the opinion of the investigator

- Female subjects who are post-menopausal (no menstrual period for a minimum of 12
months), or surgically sterilized. Female subjects of child bearing potential must
remain abstinent or use double-barrier birth control method during the period of
therapy and must be willing to use contraception 2 weeks following the last study
drug administration and have a negative serum pregnancy test upon entry into this

- Male subject is willing to use contraception upon enrollment, during the course of
the study and for 12 weeks following the last study drug administration

- Willing to provide tumor samples and / or slides

- Competent to sign and date an Institutional Review Board approved informed consent

- Hematological function, as follows:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin > 9
g/dL Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x institutional
upper limit of normal (IULN)

- Renal function, as follows:

Serum creatinine < 2.0 mg/dL

- Hepatic function, as follows:

AST/ALT < 3x ULN and total bilirubin < 1.5x ULN in all subjects Alkaline phosphatase < 2.0
x ULN (if liver or bone metastases are present, ≤ 5 x ULN)

Exclusion Criteria:

- Any disorder that compromises the ability of the subject to give written informed
consent and/or to comply with the study procedures.

- Primary central nervous system (CNS) tumors or metastases

- 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 in the opinion of the

- A baseline ECG QTc > 480 ms

- Active infection within 2 weeks of study enrollment (day 1)

- Significant gastrointestinal disorder(s), in the opinion of the investigator, (e.g.
Crohn's disease, ulcerative colitis, extensive gastrointestinal resection) that may
influence drug absorption

- Known positive test for HIV

- Known acute or chronic hepatitis B or hepatitis C infection, determined by serologic

- Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved
to CTCAE grade 0 or 1, or to levels dictated in the eligibility criteria with the
exception of alopecia

- Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy,
retinoid therapy, hormonal therapy, or investigational agent) within 28 days of study
day 1 (six weeks for nitrosureas, mitomycin C, or antibody or molecular targeted
agents with t1/2 > 10 days); concurrent use of hormone deprivation therapy for
hormone-refractory prostate cancer or breast cancer is permitted

- Treatment with immune modulators including, but not limited to, systemic
corticosteroids, cyclosporine and tacrolimus within two weeks prior to enrollment

- Therapeutic or palliative radiation therapy within 2 weeks of study day 1

- Concurrent or prior (within 7 days of study day 1) anticoagulation therapy (low-dose
warfarin [≤ 2 mg/day] or low molecular weight heparins for prophylaxis against
central venous catheter thrombosis or aspirin [81 mg/day] is allowed)

- Prior participation in an investigational study and/or procedure within 28 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 determine the maximum tolerated dose (MTD) of AMG 208, if possible

Outcome Time Frame:

3.5 years

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2008

Completion Date:

October 2013

Related Keywords:

  • Cancer
  • Oncology
  • Tumors
  • Advanced Malignancy
  • Advanced Solid Tumors
  • Oncology Patients
  • Cancer
  • Solid Tumors
  • Phase 1
  • C-met inhibitor
  • Clinical Trial
  • Neoplasms



Research SiteAnaheim, California  
Research SiteBranson, Missouri  
Research SiteAbilene, Texas