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MEDI-522

Phase 2

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

MEDI-522 development status

Highest phase Phase 2
Registered trials 6 across 1 sponsor since Sep 2003

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials7
Total Enrollment663

FDA Designations

No designations recorded

MEDI-522 clinical trials

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?

MEDI-522 is an investigational small molecule being developed by AstraZeneca PLC for cancer and inflammatory conditions. It has been studied in solid tumors including colorectal cancer and malignant melanoma, as well as in plaque psoriasis. Development has remained at the Phase 1 stage for the oncology programs.

What is MEDI-522 used for?

MEDI-522 has been studied in cancer, including irinotecan-refractory advanced colorectal cancer, refractory solid tumors, and advanced malignant melanoma. It has also been evaluated in plaque psoriasis. Listed indications for the program also include prostate cancer and rheumatoid arthritis, though clinical trials have focused on cancer and psoriasis.

Who makes MEDI-522?

MEDI-522 is developed by AstraZeneca PLC, which trades under the ticker AZN. The drug was studied across Phase 1 oncology trials in the United States and France, and in a Phase 2 plaque psoriasis study conducted in the United States and Canada.

What phase is MEDI-522 in?

MEDI-522 is in Phase 1 development for its oncology indications. The program has also included a Phase 2 trial in plaque psoriasis. MEDI-522 is investigational and has not been approved by the FDA for any indication.

What clinical trials is MEDI-522 in?

MEDI-522 has been evaluated in completed trials including NCT00284817 in irinotecan-refractory advanced colorectal cancer, NCT00263783 in refractory solid tumors, NCT00192517 in plaque psoriasis, and NCT00111696 in advanced malignant melanoma. All four studies are completed, and no MEDI-522 trials are currently active.

Is MEDI-522 the same as MEDI--522?

Yes, MEDI--522 is an alternative spelling of MEDI-522. Both names refer to the same investigational small molecule developed by AstraZeneca PLC. The drug has also appeared under the name Abergrin in a Phase 1 study of advanced malignant melanoma.