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SU014813

Phase 2

Breast Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Aug 8, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

SU014813 · 2 trials · 3 indications

Phase 2 1Phase 1 1
NCT00322517Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast CancerBreast Neoplasms
COMPLETED90 Analytics
PHASE2COMPLETED
Study Of The Efficacy And Safety Of SU-014813 In Patients With Metastatic Breast Cancer
Breast NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the antitumor efficacy of single agent SU-014813 at a dose of 100 mg orally once daily in patients with MBC
June 2008
Maximum Tolerated Dose (MTD)
18-Nov-2008

Secondary Endpoints

To assess onset and duration of tumor control and 1-year survival rate
AUG 2008
To evaluate the safety of SU-014813To assess patient reported outcomes
AUG 2008
To determine SU-014813 plasma trough concentration (Ctrough)
AUG 2008
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SU014813EXPERIMENTAL -

Interventions

NameTypeDescription
SU014813DRUG100 mg capsule/day for 6 cycle of 21 days
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Histologically or cytologically proven diagnosis of metastatic breast adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent. * Must have received prior treatment with an anthracycline and a taxane either concurrently or se...

Countries:United StatesGermanyItalyNetherlandsUnited Kingdom
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Frequently asked questions about SU014813

What is SU014813 used for?

SU014813 is an investigational small molecule being studied for the treatment of breast cancer and other solid tumors. It was evaluated in patients with metastatic breast cancer and in patients with advanced solid malignancies. The drug is being developed by Pfizer, Inc. and is currently in Phase 2 clinical development.

Who makes SU014813?

SU014813 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule in the oncology therapeutic area, and it has not been approved by regulatory authorities.

What phase is SU014813 in?

SU014813 is in Phase 2 clinical development. It has completed one Phase 2 trial in patients with metastatic breast cancer and one Phase 1 trial in patients with advanced solid tumors. The drug remains investigational and has not received regulatory approval.

What clinical trials is SU014813 in?

SU014813 has been studied in two completed clinical trials. NCT00322517 was a Phase 2 study of the efficacy and safety of SU-014813 in patients with metastatic breast cancer, enrolling 90 female patients. NCT00982267 was a Phase 1 trial of SU14813 in patients with advanced solid malignancies, enrolling 77 patients.

Is SU014813 the same as SU-014813 or SU14813?

Yes, SU014813 is also known as SU-014813 and SU14813. These names refer to the same investigational drug developed by Pfizer. The Phase 2 trial used the name SU-014813, while the Phase 1 trial used the name SU14813.