QUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid Tumors

NCT00974896 | Completed Phase 1

• 2 other identifiers: 20060134QUILT-2.016
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the safety, tolerability, and pharmacokinetic profiles of AMG 479 when used in combination with bevacizumab, sorafenib, panitumumab, erlotinib, or gemcitabine in subjects with advanced solid tumors. Up to 126 subjects may be enrolled. Sorafenib and erlotinib combo cohorts are enrolling. All other combo cohorts are closed to enrollment.

Conditions

Advanced Malignancy; Advanced Solid Tumors; Cancer; Solid Tumors; Tumors

Keywords

Advanced Solid Tumors; AMG 479; Amgen; Oncology; Phase 1b

Outcome Measures

Primary Outcomes (1)

• To assess the safety, tolerability, and pharmacokinetic profiles of AMG 479 when used in combination with bevacizumab, sorafenib, panitumumab, erlotinib or gemcitabine in subjects with advanced solid tumors

  3 years

Secondary Outcomes (4)

• To evaluate pharmacokinetic (PK) profiles of biologics or chemotherapy when used in combination with AMG 479

  3 years

• To evaluate tumor response as assessed by World Health Organization (WHO) criteria

  3 years

• To evaluate tumor response as measured by volumetric computed tomography (CT)

  3 years

• To evaluate anti-AMG 479 antibody response following AMG 479 administration

  3 years

Study Arms (2)

AMG 479 + Sorafenib cohorts

EXPERIMENTAL

The aim is to determine the safety, tolerability and PK of AMG 479 with sorafenib. AMG 479 will be given bi-weekly; sorafenib will be given daily.

Drug: AMG 479

AMG 479 + Erlotinib cohorts

EXPERIMENTAL

The aim is to determine the safety, tolerability and PK of AMG 479 with erlotinib. AMG 479 will be given bi-weekly; erlotinib will be given daily.

Drug: AMG 479

Interventions

AMG 479 DRUG

AMG 479 is a fully human IgG1 monoclonal antibody that inhibits IGF-1R signalling. AMG 479 (6mg/kg or 12mg/kg) will be given IV every 2 weeks in combination with sorafenib (400 mg po BID) or erlotinib (150 mg po QD).

AMG 479 + Erlotinib cohorts; AMG 479 + Sorafenib cohorts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
• Men and women ≥ 18 years old with a pathologically or cytologically documented, advanced solid tumor that is refractory to at least one line of therapy or for whom no standard therapy is available and for which no curative therapy is available, or the subject refuses standard non-curative therapy
• Measurable disease or evaluable disease per World Health Organization (WHO) guidelines
• Eastern Cooperative Oncology Group performance status ≤ 2
• Life expectancy of 3 months as documented by the investigator
• Adequate hematologic, renal and hepatic function

You may not qualify if:

• Any co-morbid medical condition that would increase the risk of toxicity in the opinion of Investigator or Sponsor
• Subjects with primary or metastatic central nervous system (CNS) tumors are not allowed to enroll in the sorafenib cohorts. These subjects are allowed to enroll in the remaining cohorts, only if their CNS tumors have been controlled by prior surgery or radiation, and they have been neurologically stable
• History of lymphoma, leukemia, or high-dose chemotherapy with hematopoietic stem cell rescue
• Uncontrolled hypertension \[diastolic \>100 mmHg or systolic \>150 mmHg\]; Subjects enrolling in the sorafenib groups must not have diastolic \> 85 mmHg nor systolic \> 145 mmHg
• Clinically significant ECG changes which obscure the ability to assess the PR, QT, QRS intervals
• Presence of ascites or pleural effusion requiring chronic medical intervention
• Diagnosis of arterial or venous thrombosis within 6 months before enrollment; history of bleeding diathesis
• History of clinically significant hypoglycemia or hyperglycemia in the opinion of the investigator
• Myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure (New York Heart Association \>class II), unstable angina, or unstable cardiac arrhythmia requiring medication
• Active peptic ulcer disease
• History of chronic hepatitis
• Subject known to have tested positive for HIV
• Known sensitivity to mammalian derived products
• Hematological function, as follows:
• Absolute neutrophil count (ANC) ≤ 1.5 x 109/L for B, P, S and E cohorts

Sponsors & Collaborators

• NantCell, Inc.: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Neoplasms

Interventions

ganitumab

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: December 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: April 1, 2011
• Last Updated: October 27, 2016

Record last verified: 2016-10