Recent Updates
Recently added Catalysts

CPG 7909

Phase 2

Carcinoma, Melanoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 30, 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment184

FDA Designations

No designations recorded

Clinical trial landscape

CPG 7909 · 4 trials · 4 indications

Phase 2 2Phase 1 2
NCT00070642CPG 7909 Injection in MelanomaCarcinoma, Melanoma
COMPLETED184 Analytics
NCT00070629CPG 7909 Injection in Non-Small Cell Lung CancerCarcinoma, Non-Small Cell Lung
COMPLETED116 Analytics
PHASE2COMPLETED
CPG 7909 Injection in Melanoma
Carcinoma, MelanomaUnlock trial analytics
PHASE2COMPLETED
CPG 7909 Injection in Non-Small Cell Lung Cancer
Carcinoma, Non-Small Cell LungUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria.
indeterminate
Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II.
Indeterminate
Efficacy- overall response rate (CR & PR) according to the RECIST criteria
Indeterminate
Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations
Indeterminate
To determine the tolerability of escalating doses of subcutaneously administered CPG 7909 Injection up to a maximum dose of 0.81 mg/kg in patients with metastatic renal cell cancer.
Indeterminate
To establish the maximum tolerated dose for CPG 7909 Injection as monotherapy in patients with metastatic renal cell cancer up to a dose of 0.81mg/kg.
Indeterminate
To estimate the overall tumor response rate of CpG 7909 according to the RECIST criteria in patients with metastatic renal cell cancer.
Indeterminate
Phase I: To evaluate the safety, tolerability and and MTD of several dose levels of CPG 7909 of CPG 7909 in combination with the standard Herceptin® treatment in patients with metastatic breast cancer
Phase II: Evaluate tumor response and safety of CPG 7909 in combination with Herceptin® in patients with metastatic breast cancer

Secondary Endpoints

Phase III: Assess the overall response rate
indeterminate
Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease.
indeterminate
Determine the duration of response.
indeterminate
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CPG 7909 Injection plus chemotherapyEXPERIMENTALCPG 7909 Injection plus DTIC
Chemotherapy aloneACTIVE_COMPARATORdacarbazine
CPG 7909 Injection 10 mgEXPERIMENTAL -
CPG 7909 Injection 40 mgEXPERIMENTAL -
1EXPERIMENTALChemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection
2ACTIVE_COMPARATORChemotherapy (a taxane and a platinum compound)
CPG 7909 InjectionEXPERIMENTAL -
Cohort 1EXPERIMENTAL0.01 mg/kg CPG 7909 plus Herceptin®
Cohort 2EXPERIMENTAL0.04 mg/kg CPG 7909 plus Herceptin®
Cohort 3EXPERIMENTAL0.16 mg/kg CPG 7909 plus Herceptin®
Cohort 4EXPERIMENTAL0.32 mg/kg CPG 7909 plus Herceptin®

Interventions

NameTypeDescription
CPG 7909 InjectionDRUGCPG 7909 Injection administered subcutaneously at a dose of 40 mg weekly.
dacarbazineDRUGdacarbazine 850mg/m2 in three-week cycles until disease progression
ChemotherapyDRUGChemotherapy in three-week cycles until disease progression: dacarbazine 850mg/m2
CPG 7909DRUGCPG 7909 Injection will be administered subcutaneously at a starting dose of 0.20 mg/kg at the beginning of Weeks 2 and 3 of the three-week cycle.
Herceptin®DRUGHerceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Histologically or cytologically confirmed melanoma that is metastatic. * Measurable disease according to the RECIST criteria. * Karnofsky Performance Status of \> 70. Exclusion Criteria: * Prior treatment with anti-neoplastic biologic or chemotherapy for recurrent or metasta...

Countries:United StatesCanadaGermany
Unlock Eligibility Criteria

Frequently asked questions about CPG 7909

What is CPG 7909 used for?

CPG 7909 is an investigational small molecule being studied in oncology for several cancers, including metastatic breast cancer, renal cell cancer, non-small cell lung cancer, and melanoma. It is being developed by Pfizer, Inc. (PFE) and has completed clinical trials in these indications.

What does CPG 7909 target?

CPG 7909 is a small molecule immunomodulator that targets Toll-like receptor 9 (TLR9). By activating TLR9, it is designed to stimulate the immune system to recognize and attack cancer cells. This mechanism is being evaluated in multiple oncology indications.

Who makes CPG 7909?

CPG 7909 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer types.

What phase is CPG 7909 in?

CPG 7909 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials in oncology indications, including non-small cell lung cancer and melanoma. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is CPG 7909 in?

CPG 7909 has been studied in several completed clinical trials, including NCT00031278 in metastatic breast cancer, NCT00043407 in renal cell cancer, NCT00070629 in non-small cell lung cancer, and NCT00070642 in melanoma. These trials enrolled a total of 354 patients.

Is CPG 7909 the same as any other drug?

CPG 7909 is also known by the name PF-3512676. This alternative name may be used in scientific literature and clinical trial registries. Both names refer to the same investigational small molecule being developed by Pfizer for oncology indications.