Trial record 1 of 1 for:
m11-849
An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types
This study has been completed.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01472003
First received: October 12, 2011
Last updated: January 10, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This is an open label study designed to evaluate the biodistribution and imaging characteristics of ABT-806i (111In-ABT-806) in subjects with advanced solid tumor types.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: ABT-806 Drug: ABT-806i |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | An Evaluation of the Biodistribution and Imaging Characteristics of ABT-806i (111In-ABT-806) in Subjects With Advanced Solid Tumor Types Likely to Express Epidermal Growth Factor Receptor (EGFR) |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Single-Photon Emission Computerized Tomography (SPECT) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]Tumor receptor occupancy (Cohort 1 and Cohort 2)
- Single-Photon Emission Computerized Tomography (SPECT) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]Tumor receptor occupancy (Cohort 2)
- Whole body planar imaging [ Time Frame: Week 1 ] [ Designated as safety issue: No ]Biodistribution and dosimetry (Cohort 1 and Cohort 2)
- Whole body planar imaging [ Time Frame: Week 6 ] [ Designated as safety issue: No ]Biodistribution and dosimetry (Cohort 2)
Secondary Outcome Measures:
- Pharmacokinetic profile evaluation - Cohort 1 [ Time Frame: From Day 1 through Final Visit ] [ Designated as safety issue: Yes ]Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints
- Pharmacokinetic profile evaluation - Cohort 2 [ Time Frame: From Day 1 through Final Visit ] [ Designated as safety issue: Yes ]Blood samples for ABT-806/ABT-806i will be collected and assayed at designated timepoints
- Single-Photon Emission Computerized Tomography (SPECT) [ Time Frame: Week 1 ] [ Designated as safety issue: No ]ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2
- Single-Photon Emission Computerized Tomography (SPECT) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]ABT-806i uptake correlation with EGFR vIII expression - Cohort 2
- Whole body planar imaging [ Time Frame: Week 1 ] [ Designated as safety issue: No ]ABT-806i uptake correlation with Epidermal Growth Factor Receptor (EGFR) vIII expression - Cohort 2
- Whole body planar imaging [ Time Frame: Week 6 ] [ Designated as safety issue: No ]ABT-806i uptake correlation with EGFR vIII expression - Cohort 2
- Blood pressure - Cohort 1 [ Time Frame: Screening through Week 2 ] [ Designated as safety issue: Yes ]
- Heart rate - Cohort 1 [ Time Frame: Screening through Week 2 ] [ Designated as safety issue: Yes ]
- Body temperature - Cohort 1 [ Time Frame: Screening through Week 2 ] [ Designated as safety issue: Yes ]
- Number of subjects with Adverse Events - Cohort 1 [ Time Frame: Day 1 Through Week 2 ] [ Designated as safety issue: Yes ]The investigator will monitor each subject for clinical and laboratory evidence of adverse events.
- Chemistry - Cohort 1 [ Time Frame: Sceening, Week 1 and Final Visit ] [ Designated as safety issue: Yes ]
- Hematology - Cohort 1 [ Time Frame: Sceening, Week 1 and Final Visit ] [ Designated as safety issue: Yes ]
- Urinalysis - Cohort 1 [ Time Frame: Sceening, Week 1 and Final Visit ] [ Designated as safety issue: Yes ]
- Physical Examination - Cohort 1 [ Time Frame: Screening, Week 1 and Final Visit ] [ Designated as safety issue: Yes ]Physical exam including body weight will be performed.
- Electrocardiogram (ECG) - Cohort 1 [ Time Frame: Baseline and Final Visit ] [ Designated as safety issue: Yes ]12-lead ECG will be performed.
- Heart rate - Cohort 2 [ Time Frame: Screening Through Week 8 ] [ Designated as safety issue: Yes ]
- Blood pressure - Cohort 2 [ Time Frame: Screening Through Week 8 ] [ Designated as safety issue: Yes ]
- Number of subjects with Adverse Events - Cohort 2 [ Time Frame: Day 1 Through Week 8 ] [ Designated as safety issue: Yes ]The investigator will monitor each subject for clinical and laboratory evidence of adverse events.
- Body temperature - Cohort 2 [ Time Frame: Screening Through Week 8 ] [ Designated as safety issue: Yes ]
- Hematology - Cohort 2 [ Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit ] [ Designated as safety issue: Yes ]
- Chemistry - Cohort 2 [ Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit ] [ Designated as safety issue: Yes ]
- Physical Examination - Cohort 2 [ Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit ] [ Designated as safety issue: Yes ]Physical exam including body weight will be performed.
- Urinalysis - Cohort 2 [ Time Frame: Screening, Week 1, 2, 4, 6, and Final Visit ] [ Designated as safety issue: Yes ]
- Electrocardiogram (ECG) - Cohort 2 [ Time Frame: Baseline and Week 6 ] [ Designated as safety issue: Yes ]12-lead ECG will be performed.
| Enrollment: | 18 |
| Study Start Date: | October 2011 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ABT-806 Arm
Subjects with advanced solid tumors
|
Drug: ABT-806
ABT-806 will be administered by intravenous infusion.
|
|
Experimental: ABT-806i Arm
Subjects with advanced solid tumors
|
Drug: ABT-806i
ABT-806i will be administered by intravenous infusion.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject has a solid tumor of a type likely or known to either overexpress wild-type Epidermal Growth Factor Receptor (EGFR) or to express variant III mutant EGFR (e.g., head and neck squamous cell carcinoma, Non-small Cell Lung Carcinoma (NSCLC), and colorectal carcinoma).
- Subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent.
- Subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage.
- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Subject must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 with at least 1 extrahepatic 2 cm lesion.
Exclusion Criteria:
- Subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 14 days prior to the first dose of ABT-806i.
- Subject has received a prior EGFR-directed monoclonal antibody within a period of 4 weeks prior to the first dose of ABT-806i.
- Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
- Subject has had major surgery within 21 days prior to the first dose of ABT-806i.
Subject has a clinically significant uncontrolled condition(s) including but not limited to the following:
- Active uncontrolled infection
- Symptomatic congestive heart failure
- Unstable angina pectoris or cardiac arrhythmia
- Psychiatric illness/social situation that would limit compliance with the study requirements
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472003
Locations
| Australia | |
| Site Reference ID/Investigator# 52203 | |
| Heidelberg, Australia, 3084 | |
| Site Reference ID/Investigator# 58242 | |
| Herston, Australia, 4029 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | Kyle D. Holen, MD | AbbVie |
More Information
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01472003 History of Changes |
| Other Study ID Numbers: | M11-849 |
| Study First Received: | October 12, 2011 |
| Last Updated: | January 10, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013