Register a trial

Please note that the ANZCTR website will be unavailable from 1:00pm until 2:00pm (AEST) on Thursday 10th of April for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.


The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

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
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)
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)
Secondary ID [1] 0 0
M16-438
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AUCt for ABBV-321
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
Timepoint [1] 0 0
Up to 78 days post dose
Primary outcome [2] 0 0
AUC8 for ABBV-321
Assessment method [2] 0 0
AUC8 is the area under the plasma concentration-time curve from Time 0 to infinite time.
Timepoint [2] 0 0
Up to 78 days post dose
Primary outcome [3] 0 0
Tmax of ABBV-321
Assessment method [3] 0 0
Time to Cmax (Tmax) of ABBV-321
Timepoint [3] 0 0
Up to 78 days post dose
Primary outcome [4] 0 0
Terminal phase elimination rate constant (ß) for ABBV-321
Assessment method [4] 0 0
Terminal phase elimination rate constant (ß)
Timepoint [4] 0 0
Up to 78 days post dose
Primary outcome [5] 0 0
Cmax of ABBV-321
Assessment method [5] 0 0
Maximum observed plasma concentration (Cmax) of ABBV-321
Timepoint [5] 0 0
Up to 78 days post dose
Primary outcome [6] 0 0
Dose Escalation Phase: Recommended Phase 2 dose (RPTD) for ABBV-321
Assessment method [6] 0 0
The RPTD will be determined using available safety and pharmacokinetics data upon completion of the Dose Escalation Phase
Timepoint [6] 0 0
Minimum first cycle of dosing (up to 28 days)
Primary outcome [7] 0 0
t1/2 for ABBV-321
Assessment method [7] 0 0
Terminal elimination half-life (t1/2)
Timepoint [7] 0 0
Up to 78 days post dose
Primary outcome [8] 0 0
Dose Escalation Phase: Maximum tolerated dose (MTD) of ABBV-321
Assessment method [8] 0 0
The MTD of ABBV-321 will be determined during the dose escalation phase of the study.
Timepoint [8] 0 0
Minimum first cycle of dosing (up to 28 days)
Secondary outcome [1] 0 0
Progression-Free Survival (PFS)
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.
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
Duration of Response (DOR)
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.
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
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.
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
Time to progression (TTP)
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.
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
Change from Baseline in QTcF
Assessment method [5] 0 0
QT interval measurement corrected by Fridericia's formula (QTcF) change from baseline
Timepoint [5] 0 0
Up to 61 days post dose
Secondary outcome [6] 0 0
Overall Survival (OS)
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.
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
Objective response rate (ORR)
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.
Timepoint [7] 0 0
Up to 5 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/04/2021
Sample size
Target
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Northern Cancer Institute /ID# 166138 - St Leonards
Recruitment hospital [2] 0 0
Monash Health /ID# 217435 - Clayton
Recruitment hospital [3] 0 0
Austin Hospital /ID# 166137 - Heidelberg
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Rhode Island
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Israel
State/province [11] 0 0
Ramat Gan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


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