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AZD2461

Phase 1

Refractory Solid Tumors | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jun 6, 2012

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment75

FDA Designations

No designations recorded

Clinical trial landscape

AZD2461 · 1 trial · 2 indications

Phase 1 1
NCT01247168An Open-Label, Dose-Escalation Study of AZD2461Refractory Solid Tumors
COMPLETED75 Analytics
PHASE1COMPLETED
An Open-Label, Dose-Escalation Study of AZD2461
Refractory Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the maximum tolerated dose of AZD 2461 by collection of adverse events, hematology, clinical chemistry data and vital signs.
Day 1

Secondary Endpoints

To characterize the pharmacokinetic profile of AZD2461 by collection of blood samples for the measurement of AZD2461 in plasma concentration
Continuous dosing Cycle 1 and 2, Day 1 (pre-dose, 1-hr, 6-hr and 24-hr)
evaluate the pharmacodynamic response after treatment with AZD2461 as the change in PARP (Poly (ADP-ribose) polymerase) inhibition in PBMCs (peripheral blood mononuclear cell)
weekly
To explore the clinical tumor response after treatment with AZD2461 as the assessment of patients with overall tumor response Complete Response (CR), Partial Response (PR), duration of response, stable disease (SD) and time to disease progression
every 6 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
AZD2461DRUGoral capsules, continuous dosing and intermittent dosing
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with confirmed diagnosis of solid tumor malignancy that is not responsive to standard therapies or for which there is no effective therapy. * Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1 * Patients must be 18 years of age * Using adequate contra...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Refractory Solid Tumors")

Frequently asked questions about AZD2461

What is AZD2461 used for?

AZD2461 is an investigational small molecule being studied for the treatment of refractory solid tumors, including cancer tumors. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is intended for patients with advanced cancers that have not responded to prior therapies.

Who makes AZD2461?

AZD2461 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. AstraZeneca is conducting clinical research on this investigational oncology drug for refractory solid tumors.

What phase is AZD2461 in?

AZD2461 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being evaluated in clinical trials. The drug is being studied for safety and dosing in patients with refractory solid tumors.

What clinical trials is AZD2461 in?

AZD2461 has one completed clinical trial, identified as NCT01247168. This was an open-label, dose-escalation study conducted in the United States with 75 participants aged 18 years and older. The trial enrolled patients with refractory solid tumors and cancer tumors.

Is AZD2461 FDA approved?

AZD2461 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT01247168, was a dose-escalation study, but the drug has not yet received regulatory approval for any indication.