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CPG 7909

Phase 2

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

CPG 7909 development status

Highest phase Phase 2
Registered trials 6 across 2 sponsors since Mar 2002

CPG 7909 target and mechanism

ModalitySmall molecule

Also known as CPG 7909 Injection, PF-03512676

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials4
Total Enrollment354

FDA Designations

No designations recorded

CPG 7909 clinical trials

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
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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
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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
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Frequently asked questions about CPG 7909

What is CPG 7909?

CPG 7909 is an investigational oncology drug developed by Pfizer, Inc. (ticker: PFE). It has been studied in several cancer types, including melanoma, metastatic breast cancer, non-small cell lung cancer, and renal cell carcinoma. It is also known as CPG 7909 Injection.

What is CPG 7909 used for?

CPG 7909 has been studied for the treatment of several cancers: melanoma, metastatic breast cancer, non-small cell lung cancer, and renal cell carcinoma. These are the indications explored in its clinical trials. It is not described as approved for any indication.

Who makes CPG 7909?

CPG 7909 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company associated with the clinical development of CPG 7909 Injection across the studied cancer indications.

What phase is CPG 7909 in?

CPG 7909 is in Phase 2 development. Its clinical program includes Phase 2 trials in melanoma and non-small cell lung cancer, along with Phase 1 trials in renal cell carcinoma and metastatic breast cancer. All listed trials are completed.

What clinical trials is CPG 7909 in?

CPG 7909 has been evaluated in completed trials including NCT00070642 in melanoma, NCT00070629 in non-small cell lung cancer, NCT00043407 in stage IV renal cell cancer, and NCT00031278 in metastatic breast cancer. These studies are completed, and no trials are currently active.

Is CPG 7909 the same as CPG 7909 Injection?

Yes, CPG 7909 Injection is another name for CPG 7909. The two names refer to the same investigational oncology drug developed by Pfizer, Inc. (ticker: PFE).