A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered AMG 900 in Adult Subjects With Advanced Solid Tumors
| City: |
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Albuquerque |
| State: |
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New Mexico |
| Zip Code: |
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87131 |
| Conditions: |
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Advanced Malignancy - Advanced Solid Tumors - Cancer - Solid Tumors - Tumors |
| Purpose: |
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This first-in-human study of AMG 900 will be conducted in two parts: dose escalation and
dose expansion. The dose escalation part of the study is aimed at evaluating the safety,
tolerability and PK of oral AMG 900 in subjects with advanced solid tumors. Up to 50
subjects may be enrolled in dose escalation. The dose expansion part of the study will
consist of 42 subjects in three taxane-resistant tumor types. The dose of AMG 900 will be
dependent upon data from the dose escalation part of the study
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Men or women ≥ 18 years old
- Part 1 Dose Escalation only: advanced solid tumor refractory to standard treatment
for which no standard therapy is available or the subject refuses standard therapy
- Part 1 Dose Escalation only: Measurable or evaluable disease per RECIST guidelines
- Part 2 Dose Expansion only: Taxane-resistant tumor (defined as refractory to or
progression within 6 months of discontinuing paclitaxel or docetaxel) of prespecified
histology
- Part 2 Dose Expansion only: Measurable disease per RECIST guidelines
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Life expectancy of > 3 months, in the opinion of the investigator
- Willing to provide existing and/or future paraffin-embedded tumor samples
- Part 1 Dose Escalation: must have tumor tissue that is accessible for biopsy by fine
needle aspiration (FNA) and must consent to undergo biopsies of their tumor (subjects
in non-accelerated phase only)
- Ability to take oral medications
- Competent to sign and date an Institutional Review Board approved informed consent
form
- 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 upper limit of
normal (ULN)
- Serum creatinine < 2.0 mg/dL
- Calculated creatinine clearance ≥ 50 ml/min
- AST < 2.5 x ULN (if liver or bone metastases are present, ≤ 5 x ULN)
- ALT < 2.5 x ULN (if liver or bone metastases are present, ≤ 5 x ULN)
- Alkaline phosphatase < 2.0 x ULN (if liver or bone metastases are present, ≤ 5 x ULN)
- Total bilirubin < 1.5 x ULN
Exclusion Criteria:
- Active parenchymal brain metastases. Subjects who have had brain metastases resected
or have received radiation therapy ending at least 4 weeks prior to study day 1 are
eligible if they meet all of the following criteria: a) residual neurological
symptoms grade < 1; b) no dexamethasone requirement; and c) follow-up MRI shows no
new lesions appearing
- Prior bone marrow transplant (autologous or allogeneic)
- History or presence of hematological malignancies
- 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
- Active peptic ulcer disease
- Gastrointestinal (GI) tract disease causing the inability to take oral medication,
malabsorption syndrome, requirement for intravenous alimentation, prior surgical
procedures affecting absorption, uncontrolled inflammatory GI disease (eg, Crohn's
disease, ulcerative colitis)
- Active infection requiring intravenous (IV) antibiotics within 2 weeks of study
enrollment (day 1)
- Known positive test for HIV
- Active or chronic hepatitis B or hepatitis C infection, determined by serologic tests
- Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved
to Common Terminology Criteria for Adverse Events (CTCAE) grade 0 or 1, or to levels
dictated in the eligibility criteria with the exception of alopecia
- Anti-tumor therapy within 28 days of study day 1; 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, corticosteroids,
cyclosporine and tacrolimus within two weeks prior to enrollment
- Therapeutic or palliative radiation therapy within two weeks of study day 1
- Systemic anticoagulation therapy, including warfarin, within 28 days of day 1
- Prior treatment with aurora inhibitors
- Prior participation in an investigational study (drug or device) within 28 days of
study day 1
- Major surgery within 28 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
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| NCT ID: |
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NCT00858377 |
| Primary Contact: |
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Study Director
MD
Amgen
Amgen Call Center
Phone: 866-572-6436
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| Backup Contact: |
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N/A |
| Location Contact: |
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Albuquerque, New Mexico 87131
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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