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MEDI-522

Phase 2

Melanoma | Monoclonal antibody | Oncology |AstraZeneca PLC|Last Updated: Mar 14, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

MEDI-522 · 7 trials · 7 indications

Phase 2 4Phase 1 3
NCT00072930MEDI-522 in the Treatment of Patients With Metastatic Androgen-Independent Prostate CancerProstate Cancer
COMPLETED150 Analytics
NCT00192517Study of MEDI-522 Administered by Subcutaneous Injection to Adults With Plaque PsoriasisPsoriasis
COMPLETED44 Analytics
NCT00069017Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients With Active Rheumatoid Arthritis Suboptimally Responding to MethotrexateRheumatoid Arthritis
COMPLETED300 Analytics
NCT00066196Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic MelanomaMelanoma
COMPLETED110 Analytics
PHASE2COMPLETED
MEDI-522 in the Treatment of Patients With Metastatic Androgen-Independent Prostate Cancer
Prostate CancerUnlock trial analytics
PHASE2COMPLETED
Study of MEDI-522 Administered by Subcutaneous Injection to Adults With Plaque Psoriasis
PsoriasisUnlock trial analytics
PHASE2COMPLETED
Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate
Rheumatoid ArthritisUnlock trial analytics
PHASE2COMPLETED
Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to disease progression
Baseline to disease progression
PSA Response Rate
Baseline to disease progression
Tumor Response Rate
Baseline to disease progression
Percentage of subjects achieving at least a 50% or 75% improvement of PASI
PASI score at Study Days 28, 56, 77, 91, 107, 137, and 167.
Explore antitumor activity of MEDI-522 in patients with metastatic melanoma.
Screening and after every 2 cycles of treatment until disease progression. At least 4 weeks after a patient demonstrates response.
The primary outcome of this study is to describe the tumor tissue saturation by MEDI-522 in patients with advanced malignant melanoma.
Baseline to disease progression
The recommended Phase II dose will be based on acceptable dose-limiting toxicity
Study Days 0, 7, 14, 21, 28, 35, 42, and 49.
Safety: The incidence and severity of adverse experiences and laboratory abnormalities will be tabulated and presented overall and by dose.
Study Day 1 up to 8 weeks

Secondary Endpoints

Anti-bone resorption assessed as the incidence of skeletal related events (SREs). (SREs) are defined as radiotherapy, surgery, pathologic bone fracture, spinal cord fracture. Overall survival will also be measured.
Baseline to disease progression
Incidence of adverse events and serious adverse events
through Study Day 167
Determine the safety of MEDI-522 and/or DTIC in this patient population.
Every week until disease progression, and 30 days after disease progression.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORMEDI-522 + Docetaxel + Prednisone + Zoledronic Acid (N=55)
2OTHERDocetaxel + Prednisone + Zoledronic Acid (N=55)
MEDI-522EXPERIMENTALDrug
3EXPERIMENTALMEDI-522
4EXPERIMENTALMEDI-522
5EXPERIMENTALMEDI-522

Interventions

NameTypeDescription
MEDI-522BIOLOGICALIV at a concentration of 50 mg/mL and 10mL vials
Docetaxel + Prednisone* + Zoledronic AcidBIOLOGICALIV 75 mg/m2 IV 3-4 mg 5 mg
PlaceboOTHER4 mg/kg(for 12 weeks based on patient's weight, to the nearest kg, obtained on Study Day 0)
MEDI--522BIOLOGICALIV administration supplied in 10 mL vials containing 100 mg of MEDI-522 at a concentration of 10 mg/mL.
Integrin + DacarbazineBIOLOGICALsupplied in other formulations
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites57

Inclusion Criteria: * Adult men at least 18 years of age at the time of randomization. * Metastatic, histologically or cytologically confirmed adenocarcinoma of the prostate that has progressed after start of androgen deprivation therapy, which includes prior orchiectomy or medical castration using...

Countries:United StatesBelgiumCanadaHungaryIsraelPolandRussiaFrance
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Frequently asked questions about MEDI-522

What is MEDI-522 used for?

MEDI-522 is an investigational small molecule being studied for use in oncology and inflammatory conditions. Its clinical development has focused on malignant melanoma, metastatic melanoma, refractory solid tumors, and irinotecan-refractory advanced colorectal cancer. It has also been explored for psoriasis, prostate cancer, and rheumatoid arthritis, though no approved indication exists.

Who makes MEDI-522?

MEDI-522 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The drug is an investigational small molecule that has been evaluated in clinical trials for multiple cancer types, including melanoma and colorectal cancer.

What phase is MEDI-522 in?

MEDI-522 is in Phase 1 clinical development. It has completed Phase 1 trials in patients with advanced malignant melanoma, refractory solid tumors, and irinotecan-refractory advanced colorectal cancer. The drug is investigational and has not been approved by regulatory authorities for any use.

What clinical trials is MEDI-522 in?

MEDI-522 has completed several clinical trials, including NCT00066196, a Phase 2 study of MEDI-522 with or without dacarbazine in metastatic melanoma; NCT00111696, a Phase 1 tumor saturation study in advanced malignant melanoma; NCT00263783, a Phase 1 trial in refractory solid tumors; and NCT00284817, a Phase 1 study in irinotecan-refractory colorectal cancer.

Is MEDI-522 the same as Abergrin?

Yes, MEDI-522 is also known as Abergrin. In clinical trial records, the drug is referred to by both names, with the Phase 1 study NCT00111696 titled 'Study of the Tumor Saturation and Biological Activity of MEDI-522 (Abergrin) in Patients With Advanced Malignant Melanoma.'

How does MEDI-522 work?

MEDI-522 is a small molecule, but its specific molecular target has not been disclosed in the available clinical trial information. The drug has been studied for its antitumor activity in melanoma and other solid tumors, as well as for potential effects in inflammatory conditions like rheumatoid arthritis and psoriasis.