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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03234712
Registration number
NCT03234712
Ethics application status
Date submitted
27/07/2017
Date registered
31/07/2017
Titles & IDs
Public title
A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR)
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Scientific title
A Phase 1 Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR)
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Secondary ID [1]
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M16-438
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors Cancer
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABBV-321
Experimental: ABBV-321 - ABBV-321 will be administered via intravenous infusion at escalating dose levels until the maximum tolerated dose is reached and a recommended Phase 2 dose is determined.
Treatment: Drugs: ABBV-321
Intravenous infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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AUCt for ABBV-321
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Assessment method [1]
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Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt) for ABBV-321
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Timepoint [1]
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Up to 78 days post dose
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Primary outcome [2]
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AUC8 for ABBV-321
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Assessment method [2]
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AUC8 is the area under the plasma concentration-time curve from Time 0 to infinite time.
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Timepoint [2]
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Up to 78 days post dose
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Primary outcome [3]
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Tmax of ABBV-321
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Assessment method [3]
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Time to Cmax (Tmax) of ABBV-321
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Timepoint [3]
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Up to 78 days post dose
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Primary outcome [4]
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Terminal phase elimination rate constant (ß) for ABBV-321
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Assessment method [4]
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Terminal phase elimination rate constant (ß)
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Timepoint [4]
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Up to 78 days post dose
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Primary outcome [5]
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Cmax of ABBV-321
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Assessment method [5]
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Maximum observed plasma concentration (Cmax) of ABBV-321
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Timepoint [5]
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Up to 78 days post dose
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Primary outcome [6]
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Dose Escalation Phase: Recommended Phase 2 dose (RPTD) for ABBV-321
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Assessment method [6]
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The RPTD will be determined using available safety and pharmacokinetics data upon completion of the Dose Escalation Phase
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Timepoint [6]
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Minimum first cycle of dosing (up to 28 days)
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Primary outcome [7]
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t1/2 for ABBV-321
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Assessment method [7]
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Terminal elimination half-life (t1/2)
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Timepoint [7]
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Up to 78 days post dose
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Primary outcome [8]
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Dose Escalation Phase: Maximum tolerated dose (MTD) of ABBV-321
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Assessment method [8]
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The MTD of ABBV-321 will be determined during the dose escalation phase of the study.
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Timepoint [8]
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Minimum first cycle of dosing (up to 28 days)
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Secondary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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PFS is defined as the number of days from the first dose date to the earliest date of disease progression per RECIST 1.1 or RANO criteria or death, whichever occurred first.
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Timepoint [1]
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Up to approximately 5 years
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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DOR for a given participant is defined as the number of days from the day CR or PR (whichever is recorded first) occurred to the earliest date of disease progression per RECIST 1.1 or RANO criteria or death, whichever occurred first.
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Timepoint [2]
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Up to approximately 5 years
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Secondary outcome [3]
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Disease Control Rate (DCR)
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Assessment method [3]
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DCR is defined as the proportion of participants with objective evidence of complete response (CR), partial response (PR) or stable disease (SD); a participants best overall response assignment of SD must be maintained for at least 6 weeks since the first dose date of study drug.
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Timepoint [3]
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Up to 5 years
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Secondary outcome [4]
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Time to progression (TTP)
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Assessment method [4]
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TTP is defined as the number of days from the first dose date to the earliest date of disease progression per RECIST version 1.1 or RANO criteria.
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Timepoint [4]
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Up to approximately 5 years
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Secondary outcome [5]
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Change from Baseline in QTcF
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Assessment method [5]
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QT interval measurement corrected by Fridericia's formula (QTcF) change from baseline
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Timepoint [5]
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Up to 61 days post dose
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Secondary outcome [6]
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Overall Survival (OS)
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Assessment method [6]
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OS is defined as number of days from the date of the first dose to the date of death for all dosed participants. For participants who are not deceased, the data will be censored at the last known date to be alive.
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Timepoint [6]
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Up to approximately 5 years
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Secondary outcome [7]
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Objective response rate (ORR)
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Assessment method [7]
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ORR is defined as the proportion of participants with a response of partial response (PR) or better; Response Assessment in Neuro-Oncology (RANO) criteria will be used for glioblastoma (GBM) participants, and Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria will be used for all other participants.
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Timepoint [7]
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Up to 5 years
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Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Histologically or cytologically confirmed solid tumor of one of the following types associated with overexpression of Epidermal Growth Factor Receptor (EGFR). (For Expansion Phase: Subjects must have EGFR overexpression demonstrated by central assessment or Sponsor selected test).
Dose Escalation Phase:
* Colorectal cancer (CRC), Glioblastoma (GBM), squamous cell carcinoma of the head and neck (HNSCC), non-small cell lung cancer (NSCLC), bladder, cervical, esophageal, kidney or sarcoma.
* Participants must have disease that has progressed on prior treatment and is not amenable to surgical resection or other approved therapeutic options with curative intent. Participants must not be eligible for, or has refused further therapy that is likely to provide a survival benefit.
* Must have measureable disease as per RECIST Version 1.1 or RANO (for GBM).
* Minimum life expectancy of at least 12 weeks.
Expansion Phase (Solid Tumor Cohort):
* Histologically or cytologically confirmed advanced solid tumor.
* Participants must have disease that has progressed on prior treatment and is not amenable to surgical resection or other approved therapeutic options with curative intent.
* Must have measureable disease as per RECIST Version 1.1.
* Minimum life expectancy of at least 12 weeks.
Expansion Phase (GBM Cohort Only):
* Participant has recurrent primary (de novo) glioblastoma histologically confirmed at any time from initial diagnosis through latest recurrence.
* Participant has recurrent GBM per Response Evaluation in Neuro-Oncology (RANO) requirements.
* Tumor is measurable according to RANO criteria.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Active uncontrolled infection National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE Grade greater than or equal to 3).
* New York Heart Association (NYHA) Class III or IV heart failure and/or ejection fraction of < 40% as measured by echocardiogram at screening.
* Unstable angina pectoris or cardiac ventricular arrhythmia.
* Myocardial infarction or cerebrovascular accident (CVA) within 6 months.
* Documented history of capillary leak syndrome within 6 months of study enrollment.
* Grade 2 or higher peripheral edema, ascites, pleural, or pericardial effusion within 4 weeks of study enrollment or any history of recurrent grade 2 or higher effusions requiring ongoing drainage.
* Active keratitis or current corneal disorder.
* Laser-assisted in situ keratomileusis (LASIK) procedure within the last 1 year or cataract surgery within the last 3 months.
* Major surgery (including opening of the abdomen, chest) within 21 days of the first dose of study drug.
* Uncontrolled metastases from an extracranial solid tumor to the central nervous system (CNS). Participants with brain metastases from an extracranial solid tumor are eligible after definitive therapy provided they are asymptomatic for at least 2 weeks prior to first dose of ABBV-321.
* No history of medical condition resulting in nephrotic range proteinuria.
* Participants must not have been treated in anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal therapy, biologic therapy or investigational anti-cancer therapy within a period of 21 days or herbal anticancer therapy within 7 days prior to the first dose of study drug.
* For approved targeted small molecules, a washout period of 5 half-lives is adequate (no washout period required for subjects currently on erlotinib)
* Participant must not have been in more than three lines of systemic cytotoxic therapy (excluding adjuvant and neoadjuvant therapy)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/10/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/04/2021
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Sample size
Target
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Accrual to date
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Final
62
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Northern Cancer Institute /ID# 166138 - St Leonards
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Recruitment hospital [2]
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Monash Health /ID# 217435 - Clayton
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Recruitment hospital [3]
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Austin Hospital /ID# 166137 - Heidelberg
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Illinois
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Country [4]
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United States of America
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State/province [4]
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Kentucky
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Missouri
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Country [7]
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United States of America
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State/province [7]
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New York
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Country [8]
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United States of America
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State/province [8]
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North Carolina
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Country [9]
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United States of America
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State/province [9]
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Rhode Island
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Country [10]
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United States of America
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State/province [10]
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Texas
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Country [11]
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Israel
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State/province [11]
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Ramat Gan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an open-label, Phase 1, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase two dose (RPTD), and to assess the safety, preliminary efficacy, and pharmacokinetic (PK) profile of ABBV-321 for participants with advanced solid tumors likely to overexpress the epidermal growth factor receptor (EGFR). The study will consist of 2 phases: Dose Escalation Phase and Expansion Phase.
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Trial website
https://clinicaltrials.gov/study/NCT03234712
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03234712