Clinical trial NCT01741727: A Study of ABT-414 in Subjects With Solid Tumors
Official title: A Phase 1/2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of ABT-414 in Subjects With Advanced Solid Tumors Likely to Over-Express the Epidermal Growth Factor Receptor (EGFR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Squamous Cell Tumors
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-12-05
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study of ABT-414 in subjects with solid tumors.


Eligibility criteria: Inclusion Criteria:

1. Subjects must have a solid tumor type likely to over-express Epidermal Growth Factor Receptor (EGFR) (Phase 1)
2. Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
3. Subjects have available tumor tissue
4. Subjects have adequate bone marrow, renal, and hepatic function as follows: Bone marrow: Absolute neutrophil count (ANC) \>/= 1,500/mm3 Platelets \>/= 100,000/mm3; Hemoglobin \>/= 9.0 g/dL Renal function: Serum creatinine \</= 1.5 times the upper limit of the institution's normal range Hepatic function: Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \</= 1.5 times the upper limit of the institution's normal range. Subjects with liver metastasis may have an AST and ALT of \</= 5.0 x the upper limit of normal.
5. Subjects in the Phase 2 portion must have squamous cell Non-Small Cell Lung Cancer (NSCLC)
6. Eligibility is restricted to subjects with confirmed EGFR amplification in the EGFR amplified cohort

Exclusion Criteria:

1. The subject has uncontrolled metastases to the central nervous system (CNS). Subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 28 days after definitive therapy and have not received prior whole brain radiation (Phase 1 only).
2. The subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 28 days prior to the first dose of ABT-414.
3. The subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
4. The subject had had major surgery within 28 days prior to the first dose of ABT-414.
5. The subject has a history of immunologic reaction to any Immunoglobulin G (IgG) containing agent.
6. Phase 2 portion only: The subject has previous or concurrent cancer that is distinct in primary site or histology from NSCLC, except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.

Primary outcomes:
measure: Phase 1 - Safety (Number of subjects with adverse events and/or dose limiting toxicities)
timeFrame: Every 1-3 weeks for an average of 20 weeks
measure: Phase 1 - Pharmacokinetic profile
timeFrame: Multiple timepoints Week 1 and Week 7
measure: Phase 2 - Efficacy
timeFrame: Every 6-9 weeks for an average of 20 weeks
Secondary outcomes:
measure: Phase 2- Safety (Scheduled study visits occurring on average every 3 weeks)
timeFrame: Followed on average every 3 weeks for approximately 20 weeks
measure: Phase 2- Pharmacokinetic profile
timeFrame: Multiple timepoints Week 1
measure: Phase 1&2 - QT assessment
timeFrame: Week 1
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Site Reference ID/Investigator# 90333
state: Arizona
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 83156
state: Illinois
city: Boston
country: United States
facility: Site Reference ID/Investigator# 117516
state: Massachusetts
city: Boston
country: United States
facility: Site Reference ID/Investigator# 83154
state: Massachusetts
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 83155
state: Texas
city: Ottawa
country: Canada
facility: Site Reference ID/Investigator# 89035
Study officials:
affiliation: AbbVie
name: Christopher Ocampo, MD
role: STUDY_DIRECTOR
References:
citation: Munasinghe WP, Mittapalli RK, Li H, Hoffman DM, Holen KD, Menon RM, Xiong H. Evaluation of the effect of the EGFR antibody-drug conjugate ABT-414 on QT interval prolongation in patients with advanced solid tumors likely to over-express EGFR. Cancer Chemother Pharmacol. 2017 May;79(5):915-922. doi: 10.1007/s00280-017-3284-y. Epub 2017 Mar 27.