NCT01253707CompletedPhase 1
A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of AMG 337 in Adult Subjects With Advanced Solid Tumors
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Amgen
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
First in human, open-label, sequential dose escalation and expansion study of AMG 337 in subjects with advanced solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dose Escalation
Experimental
Intervention: AMG 337 (Drug)
Outcomes
Primary Outcomes
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.
Time Frame: 4 years
Determine the maximum tolerated dose of AMG 337, if possible. The MTD is defined at the highest dose level with an observed incidence of dose limiting toxicity in < 33% of subjects enrolled in a cohort.
Time Frame: 4 years
Characterize the pharmacokinetics of AMG 337 when administered orally. PK parameters will include, but are not limited to, area under the plasma concentration versus time curve (AUC) and Peak Plasma Concentration (Cmax).
Time Frame: 4 years
Secondary Outcomes
- Evaluate for clinical responses associated with AMG 337 treatment according to Response Evaluation Criteria In Solid Tumors 1.1 criteria(4 years)
Investigators
Study Sites (1)
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