A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:March 2012
End Date:June 2015

Use our guide to learn which trials are right for you!

A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DEDN6526A in Patients With Metastatic or Unresectable Melanoma

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).


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

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)
We found this trial at
5
sites
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Camperdown,
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
Sarasota, FL
Click here to add this to my saved trials