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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01522664




Registration number
NCT01522664
Ethics application status
Date submitted
20/01/2012
Date registered
31/01/2012
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma
Scientific title
A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DEDN6526A in Patients With Metastatic or Unresectable Melanoma
Secondary ID [1] 0 0
GO27935
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DEDN6526A

Experimental: Single group -


Treatment: Drugs: DEDN6526A
Multiple ascending doses
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: Incidence of adverse events
Timepoint [1] 0 0
assessed on an ongoing basis and up to 90 days following last dose of study treatment
Primary outcome [2] 0 0
Maximum tolerated dose/dose-limiting toxicities
Timepoint [2] 0 0
approximately one year after study start
Primary outcome [3] 0 0
Determination of recommended Phase II dose
Timepoint [3] 0 0
approximately 2 years
Secondary outcome [1] 0 0
Pharmacokinetics: Area under the concentration-time curve
Timepoint [1] 0 0
Pre-dose, 30 min. and 4, 24, 48 hours post-dose and Days 7, 10, 15, 17 Cycles 1-4, pre-dose and 30 min. post-dose Cycle 5 and every other cycle thereafter
Secondary outcome [2] 0 0
Anti-therapeutic antibody (ATA) levels
Timepoint [2] 0 0
Pre-dose Day 1 Cycles 1-4, and within 30 days post last dose
Secondary outcome [3] 0 0
Tumor response (tumor assessments according to RECIST criteria)
Timepoint [3] 0 0
up to approximately 1 year

Eligibility
Key inclusion criteria
- Adult patients, >/= 18 years of age

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Histologically confirmed metastatic melanoma (AJCC stage IV) or unresectable melanoma
(AJCC Stage III)

- Prior failure of >/= 1 prior treatment regimens for metastatic or unresectable
melanoma due to disease progression or unacceptable toxicity and for whom no standard
therapy is available

- Measurable disease according to RECIST criteria

- Adequate bone marrow, liver and renal function

- Female patients of childbearing potential and male patients with female partners of
childbearing potential must agree to use one highly effective form of non-hormonal
contraception or two effective forms of non-hormonal contraception through the course
of the study treatment and for 6 months after the last dose of study treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Treatment with cytotoxic or antibody based therapy within 21 days prior to first dose
of study treatment, or with any other anti-cancer therapy within 5 half-lives of the
therapy prior to first dose of study treatment

- Known active infection (including HIV and atypical mycobacterial disease, but
excluding fungal infection of the nail beds)

- Current Grad >/= 2 toxicity (except alopecia or anorexia) from prior therapy

- Grade >/= 2 peripheral neuropathy

- History of severe allergic or anaphylactic reactions to monoclonal antibody therapies
(or recombinant antibody-related fusion proteins)

- Clinically significant history of liver disease, including viral or other hepatitis,
current alcohol abuse, or cirrhosis

- Untreated or active central nervous system (CNS) metastases (progressing or requiring
anticonvulsants or corticosteroids for symptomatic control)

- Evidence of significant uncontrolled concomitant disease or disorder

- Pregnant or lactating women

- Prior treatment with any other antibody-drug conjugate (ADC) compound containing
monomethyl auristatin E (MMAE) for the treatment of melanoma

- Previous participation in a clinical trial within 30 days of the day of first study
drug administration (Cycle 1, Day 1)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- East Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This multicenter, open-label study will assess the safety and pharmacokinetics of DEDN6526A
in patients with metastatic or unresectable melanoma. Cohorts of patients will receive
escalating doses of DEDN6526A by intravenous infusion on Day 1 of each 21-day cycle. In the
absence of disease progression or unacceptable toxicity, patients may continue to receive
DEDN6552A for up to 17 cycles (1 year).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01522664
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries