AMG 172 First in Human Study in Patients With Kidney Cancer

This study is currently recruiting participants.
Verified December 2013 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01497821
First received: December 16, 2011
Last updated: December 11, 2013
Last verified: December 2013

December 16, 2011
December 11, 2013
December 2011
April 2014   (final data collection date for primary outcome measure)
  • Clinically significant or ≥ Grade 3 CTCAE changes in safety laboratory tests, physical examinations, ECGs, or vital signs [ Time Frame: 28 days after the last subject enrolled of each cohort in Part 1 and every 10 subjects enrolled in Part 2 (if available) ] [ Designated as safety issue: Yes ]
  • PK parameters including but not limited to, maximum observed concentration (Cmax), area under the concentration-time curve (AUC) and half life (t1/2) [ Time Frame: 12 time points up to 8 weeks ] [ Designated as safety issue: No ]
  • Objective response rate for subjects treated at MTD based on RECIST 1.1 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01497821 on ClinicalTrials.gov Archive Site
  • Development of human anti-human antibody against AMG 172 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Objective response rate for subjects not treated at MTD based on RECIST 1.1 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Clinical benefit as measured by duration of response per RECIST 1.1 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
AMG 172 First in Human Study in Patients With Kidney Cancer
A Phase 1 First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 172 in Subjects With Relapsed / Refractory Renal Cell Carcinoma

This is the first-in-human (Phase I) study of AMG 172, an antibody drug conjugate (ADC), in patients with kidney cancer [Clear Cell Renal Cell Carcinoma (ccRCC)] who have relapsed or who have refractory disease following at least two prior therapies. The purpose of the study is to evaluate safety and pharmacokinetics (PK) of AMG 172, and also evaluate the objective response rate in patients with ccRCC receiving AMG 172. The study will be conducted in two Parts: Part 1 will explore doses of AMG 172 to determine the safety, tolerability and pharmacokinetics to establish a maximum tolerated dose (MTD), and Part 2 (dose expansion) will examine safety, tolerability, PK and overall response rate in subjects treated at the MTD established in Part 1.

This First in- human study of AMG 172 will be conducted in two parts: Part 1 (dose exploration) and Part 2 (dose expansion). Part 1 of the study is aimed at evaluating the safety, tolerability and PK of AMG 172 in subjects with in subjects with relapsed / refractory cc RCC, and Part 2 is aimed at evaluating safety, tolerability, PK and response rate. Up to 40 subjects may be enrolled in Part 1, and up to 20 subjects may be enrolled in Part 2. The dose of AMG 172 utilized in Part 2 will be dependent upon data obtained in Part 1 of the study.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Cell Adenocarcinoma
  • Clear Cell Renal Carcinoma
  • Clear Cell Renal Cell Carcinoma
  • Renal Cell Carcinoma
Drug: AMG 172
AMG 172 is an antibody drug conjugate
  • Experimental: Dose exploration
    Pre-specified nominal doses are proposed in the dose exploration. Intermediate doses may also be used if required based on the Continuous Reassessment Method (CRM) design.
    Intervention: Drug: AMG 172
  • Experimental: Dose expansion
    Dose selected from Part 1 dose exploration.
    Intervention: Drug: AMG 172
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
May 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have a pathologically documented, definitively diagnosed, clear cell RCC that is relapsed/refractory following at least two lines of systemic therapy (one of which must be a tyrosine kinase), or the subject refuses standard therapy
  • Measurable disease per RECIST 1.1 criteria. Subjects with non-measurable, but evaluable disease are also eligible for Part 1 of the study.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
  • Willing to provide tumor samples and / or slides
  • Hematological function, as follows:

    1. Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L;
    2. Platelet count ≥ 100 x 10^9/L;
    3. Hemoglobin > 9 g/dL
  • Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal (IULN)
  • Hepatic function, as follows:

    1. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 3 x ULN;
    2. Total bilirubin < 1.5 x ULN (< 3.0 x ULN for subjects with documented Gilbert's Disease or for whom the indirect bilirubin level suggests an extrahepatic source of elevation);
    3. Alkaline phosphatase < 2 x ULN (< 5 x ULN in subjects whom the PI and sponsor agree that clinical data suggest extrahepatic source of elevation)
  • Other inclusion criteria may apply

Exclusion Criteria:

  • Known primary central nervous system (CNS) tumors or brain 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 investigator
  • Clinically significant ECG changes which obscure the ability to assess the PR, QT, and QRS interval; congenital long QT syndrome
  • A baseline ECG QTcF > 470 msec
  • Known positive test for human immunodeficiency virus (HIV)
  • Known acute or chronic hepatitis B or hepatitis C infection as determined by serologic tests
  • Other exclusion criteria may apply
Both
18 Years and older
No
Contact: Amgen Call Center 866-572-6436
United States,   France,   Germany
 
NCT01497821
20090515
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP