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DEDN6526A

Phase 1

Malignant Melanoma | Small molecule | Oncology |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

DEDN6526A · 1 trial · 1 indication

Phase 1 1
NCT01522664A Study of DEDN6526A in Patients With Metastatic or Unresectable MelanomaMalignant Melanoma
COMPLETED53 Analytics
PHASE1COMPLETED
A Study of DEDN6526A in Patients With Metastatic or Unresectable Melanoma
Malignant Melanoma
NCT0152266453
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Study Endpoints

Primary Endpoints

Safety: Incidence of adverse events
assessed on an ongoing basis and up to 90 days following last dose of study treatment
Maximum tolerated dose/dose-limiting toxicities
approximately one year after study start
Determination of recommended Phase II dose
approximately 2 years

Secondary Endpoints

Pharmacokinetics: Area under the concentration-time curve
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
Anti-therapeutic antibody (ATA) levels
Pre-dose Day 1 Cycles 1-4, and within 30 days post last dose
Tumor response (tumor assessments according to RECIST criteria)
up to approximately 1 year
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single groupEXPERIMENTAL -

Interventions

NameTypeDescription
DEDN6526ADRUGMultiple ascending doses
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

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...

Countries:United StatesAustralia
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Frequently asked questions about DEDN6526A

What is DEDN6526A used for?

DEDN6526A is an investigational small molecule being studied for the treatment of malignant melanoma, specifically in patients with metastatic or unresectable melanoma. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes DEDN6526A?

DEDN6526A is being developed by Roche Holding AG, a multinational healthcare company traded under the ticker RHHBY. The drug is currently in Phase 1 clinical trials for malignant melanoma.

What phase is DEDN6526A in?

DEDN6526A is in Phase 1 clinical development. It has completed one Phase 1 trial, and the drug remains investigational, meaning it has not been approved for commercial use.

What clinical trials is DEDN6526A in?

DEDN6526A has been studied in one completed Phase 1 clinical trial, identified as NCT01522664. This trial enrolled 53 participants with metastatic or unresectable melanoma and was conducted in the United States and Australia.

Is DEDN6526A FDA approved?

DEDN6526A is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for malignant melanoma. The completed Phase 1 trial, NCT01522664, evaluated its safety and efficacy in patients with metastatic or unresectable melanoma.