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PF-3512676

Phase 2

Melanoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Mar 12, 2009

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

PF-3512676 · 2 trials · 6 indications

Phase 2 1Phase 1 1
NCT00043368PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909)Melanoma
COMPLETED31 Analytics
PHASE2COMPLETED
PF-3512676 (CPG 7909) Injection For Patients Who Completed An Oncology Study Using PF-3512676 (CPG 7909)
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Events and DLTs will be evaluated by the Investigator and summarized.
indeterminate
Safety: Adverse events, vital signs, clinical and laboratory parameters, physical exams, and ECGs
24 weeks
Efficacy: Evaluate tumor response as measured by the Composite Assessment of Index Lesion Disease Severity (CA). The primary endpoint will be the overall tumor response rate as assessed by the CA.
24 weeks

Secondary Endpoints

No formal statistical analysis of this study will be conducted. All clinical data may be summarized and included in data listings.
indeterminate
Secondary efficacy endpoints include disease response assessed by the PGA, duration of overall response, duration of CCR, duration of PR, time to response and time to progression of disease.
indeterminate
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALPatients will be treated with the same dosing regimen and schedule of PF-3512676 Injection with which they were treated at the end of the previous PF-3512676 Injection trial. Any proposed changes to their schedule/regimen will be at the discretion of the treating physician, following consultation with Coley.
Phase I: 0.08 mg/kgEXPERIMENTALEscalating dose groups: 0.08 mg/kg PF-3512676 Injection
Phase I: 0.16 mg/kgEXPERIMENTALEscalating dose groups: 0.16 mg/kg PF-3512676 Injection
Phase I: 0.24 mg/kgEXPERIMENTALEscalating dose groups: 0.24 mg/kg PF-3512676 Injection
Phase I: 0.28 mg/kgEXPERIMENTALEscalating dose groups: 0.28 mg/kg PF-3512676 Injection
Phase I: 0.32 mg/kgEXPERIMENTALEscalating dose groups: 0.32 mg/kg PF-3512676 Injection
Phase I: 0.36 mg/kgEXPERIMENTALEscalating dose groups: 0.36 mg/kg PF-3512676 Injection
Phase II: 10 mgEXPERIMENTALPhase II: 10 mg flat dose (random assignment in Phase II)
Phase II: 25 mgEXPERIMENTALWeekly subcutaneous injections of 25 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Interventions

NameTypeDescription
PF-3512676DRUGPF-3512676 IV at doses: 0.01mg/kg, 0.16mg/kg and 0.32mg/kg PF-3512676 Injection given by subcutaneous injection at doses: 0.04mg/kg, 0.16mg/kg, 0.20mg/kg, 0.28mg/kg, 0.32mg/kg, 6mg, 10mg, 40mg.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: Immediate (within 4 weeks) prior completion of a clinical trial of PF-3512676 Injection alone or in combination with other anti-neoplastic treatment for malignancy. Exclusion Criteria: The patient has received any anti-neoplastic therapy since completing a prior trial with PF-...

Countries:United StatesGermany
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Frequently asked questions about PF-3512676

What is PF-3512676 used for?

PF-3512676 is an investigational small molecule being studied in oncology indications including non-small-cell lung carcinoma, melanoma, and cutaneous T-cell lymphoma. It has been evaluated in clinical trials for these conditions, though it remains in clinical development and is not approved.

What does PF-3512676 target?

PF-3512676 is a small molecule, but its specific molecular target has not been disclosed in available information. It is being studied for its potential effects in certain cancers, including non-small-cell lung carcinoma, melanoma, and cutaneous T-cell lymphoma.

Who makes PF-3512676?

PF-3512676 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is in Phase 1 clinical development for oncology indications.

What phase is PF-3512676 in?

PF-3512676 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Clinical trials have been completed, but the drug is not yet available for commercial use.

What clinical trials is PF-3512676 in?

PF-3512676 has been studied in several completed clinical trials, including NCT00043368, NCT00043420, and NCT00321815. These trials evaluated the drug in patients with melanoma, breast neoplasms, renal cell carcinoma, cutaneous T-cell lymphoma, and non-small-cell lung carcinoma.

Is PF-3512676 the same as CPG 7909?

Yes, PF-3512676 is also known as CPG 7909. Clinical trials have used both names to refer to the same investigational drug, which is being studied for its potential use in treating certain types of cancer.