Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03234712
Registration number
NCT03234712
Ethics application status
Date submitted
27/07/2017
Date registered
31/07/2017
Date last updated
6/05/2021
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)
Query!
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)
Query!
Secondary ID [1]
0
0
M16-438
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors Cancer
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
AUCt for ABBV-321
Query!
Assessment method [1]
0
0
Area Under the Plasma Concentration-time Curve from Time 0 to the Time of the Last Measurable Concentration (AUCt) for ABBV-321
Query!
Timepoint [1]
0
0
Up to 78 days post dose
Query!
Primary outcome [2]
0
0
AUC8 for ABBV-321
Query!
Assessment method [2]
0
0
AUC8 is the area under the plasma concentration-time curve from Time 0 to infinite time.
Query!
Timepoint [2]
0
0
Up to 78 days post dose
Query!
Primary outcome [3]
0
0
Tmax of ABBV-321
Query!
Assessment method [3]
0
0
Time to Cmax (Tmax) of ABBV-321
Query!
Timepoint [3]
0
0
Up to 78 days post dose
Query!
Primary outcome [4]
0
0
Terminal phase elimination rate constant (ß) for ABBV-321
Query!
Assessment method [4]
0
0
Terminal phase elimination rate constant (ß)
Query!
Timepoint [4]
0
0
Up to 78 days post dose
Query!
Primary outcome [5]
0
0
Cmax of ABBV-321
Query!
Assessment method [5]
0
0
Maximum observed plasma concentration (Cmax) of ABBV-321
Query!
Timepoint [5]
0
0
Up to 78 days post dose
Query!
Primary outcome [6]
0
0
Dose Escalation Phase: Recommended Phase 2 dose (RPTD) for ABBV-321
Query!
Assessment method [6]
0
0
The RPTD will be determined using available safety and pharmacokinetics data upon completion of the Dose Escalation Phase
Query!
Timepoint [6]
0
0
Minimum first cycle of dosing (up to 28 days)
Query!
Primary outcome [7]
0
0
t1/2 for ABBV-321
Query!
Assessment method [7]
0
0
Terminal elimination half-life (t1/2)
Query!
Timepoint [7]
0
0
Up to 78 days post dose
Query!
Primary outcome [8]
0
0
Dose Escalation Phase: Maximum tolerated dose (MTD) of ABBV-321
Query!
Assessment method [8]
0
0
The MTD of ABBV-321 will be determined during the dose escalation phase of the study.
Query!
Timepoint [8]
0
0
Minimum first cycle of dosing (up to 28 days)
Query!
Secondary outcome [1]
0
0
Progression-Free Survival (PFS)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Up to approximately 5 years
Query!
Secondary outcome [2]
0
0
Duration of Response (DOR)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to approximately 5 years
Query!
Secondary outcome [3]
0
0
Disease Control Rate (DCR)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Up to 5 years
Query!
Secondary outcome [4]
0
0
Time to progression (TTP)
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Up to approximately 5 years
Query!
Secondary outcome [5]
0
0
Change from Baseline in QTcF
Query!
Assessment method [5]
0
0
QT interval measurement corrected by Fridericia's formula (QTcF) change from baseline
Query!
Timepoint [5]
0
0
Up to 61 days post dose
Query!
Secondary outcome [6]
0
0
Overall Survival (OS)
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Up to approximately 5 years
Query!
Secondary outcome [7]
0
0
Objective response rate (ORR)
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Up to 5 years
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/10/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
14/04/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
62
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment hospital [1]
0
0
Northern Cancer Institute /ID# 166138 - St Leonards
Query!
Recruitment hospital [2]
0
0
Monash Health /ID# 217435 - Clayton
Query!
Recruitment hospital [3]
0
0
Austin Hospital /ID# 166137 - Heidelberg
Query!
Recruitment postcode(s) [1]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [2]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [3]
0
0
3084 - Heidelberg
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arkansas
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Illinois
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Kentucky
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Massachusetts
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Missouri
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New York
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
North Carolina
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Rhode Island
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Texas
Query!
Country [11]
0
0
Israel
Query!
State/province [11]
0
0
Ramat Gan
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03234712
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
ABBVIE INC.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03234712
Download to PDF