Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-3512676 · 3 trials · 6 indications
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | Standard of Care chemotherapy plus experimental intervention (PF-3512676) |
| B | ACTIVE_COMPARATOR | Standard of Care chemotherapy |
| 1 | EXPERIMENTAL | Patients 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/kg | EXPERIMENTAL | Escalating dose groups: 0.08 mg/kg PF-3512676 Injection |
| Phase I: 0.16 mg/kg | EXPERIMENTAL | Escalating dose groups: 0.16 mg/kg PF-3512676 Injection |
| Phase I: 0.24 mg/kg | EXPERIMENTAL | Escalating dose groups: 0.24 mg/kg PF-3512676 Injection |
| Phase I: 0.28 mg/kg | EXPERIMENTAL | Escalating dose groups: 0.28 mg/kg PF-3512676 Injection |
| Phase I: 0.32 mg/kg | EXPERIMENTAL | Escalating dose groups: 0.32 mg/kg PF-3512676 Injection |
| Phase I: 0.36 mg/kg | EXPERIMENTAL | Escalating dose groups: 0.36 mg/kg PF-3512676 Injection |
| Phase II: 10 mg | EXPERIMENTAL | Phase II: 10 mg flat dose (random assignment in Phase II) |
| Phase II: 25 mg | EXPERIMENTAL | Weekly 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. |
| Name | Type | Description |
|---|---|---|
| PF-3512676 + Erlotinib | DRUG | PF-3512676 0.2 mg/kg subcutaneously on days 1, 8 and 15 of each 21 day cycle until disease progression or unacceptable toxicity. Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity |
| Erlotinib | DRUG | Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity |
| PF-3512676 | DRUG | PF-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. |
Inclusion Criteria: * Advanced, EGFR-positive NSCLC * ECOG Performance Status 0, 1 or 2 * Measurable disease Exclusion Criteria: * Known CNS metastasis * Pre-existing autoimmune or antibody mediated disease
PF-3512676 is an investigational oncology drug developed by Pfizer, Inc. (ticker PFE). It has been studied in non-small-cell lung carcinoma, cutaneous T-cell lymphoma, and melanoma. It is a small molecule and remains in clinical development, with Phase 2 as its most advanced stage. It is also known as CPG 7909.
PF-3512676 has been studied in advanced non-small-cell lung cancer, where it was tested in combination with erlotinib. The Phase 2 trial NCT00321815 compared erlotinib with or without PF-3512676 in 43 patients with advanced non-small-cell lung cancer in the United States. The trial is completed.
Pfizer, Inc. develops PF-3512676. Pfizer trades on the New York Stock Exchange under the ticker PFE. The company sponsored the clinical trials of PF-3512676 in non-small-cell lung cancer, cutaneous T-cell lymphoma, and melanoma.
PF-3512676 is in Phase 2 development. It is investigational and has not been approved by the FDA. Its Phase 2 program includes the erlotinib combination trial NCT00321815 in advanced non-small-cell lung cancer and the follow-up study NCT00043368 for patients who completed an earlier oncology study with PF-3512676.
PF-3512676 has been evaluated in completed clinical trials. NCT00321815 was a Phase 2 active-controlled trial of erlotinib with or without PF-3512676 in advanced non-small-cell lung cancer with 43 patients. NCT00043420 was a Phase 1 trial of CPG 7909 in cutaneous T-cell lymphoma with 42 patients. NCT00043368 was a Phase 2 follow-up study with 31 patients.
Yes, PF-3512676 is also known as CPG 7909. The two names refer to the same investigational compound. Pfizer studied it under both names, including the Phase 1 cutaneous T-cell lymphoma trial NCT00043420 and the Phase 2 follow-up study NCT00043368, which used the CPG 7909 designation.