C6461003 - AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER

Conditions

Metastatic Colorectal Cancer

Brief summary

PFS by BICR, OS

Detailed description

• PFS by investigator • ORR by BICR and by investigator • DOR by BICR and by investigator • PFS2 (PFS after next-line therapy) by investigator, • AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study intervention. • Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing., • Predose and postdose concentrations of PF-08634404, • Incidence of ADA against PF-08634404, • Mean score change from baseline in participant reported GHS/QoL, function, and symptoms per EORTC QLQ-C30 • Mean score change from baseline in participant reported function and symptoms scales per EORTC QLQ-CR29, • Time to definitive deterioration in participant reported GHS/QoL, function and symptoms per EORTC QLQ-C30 • Time to definitive deterioration in participant reported function and symptoms per EORTC QLQ-CR29

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGBEVACIZUMAB

DRUGOXALIPLATIN

DRUGCALCIUM FOLINATE

DRUGFLUOROURACIL

DRUGPF-08634404

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS by BICR, OS	—

Secondary

Measure	Time frame
• PFS by investigator • ORR by BICR and by investigator • DOR by BICR and by investigator • PFS2 (PFS after next-line therapy) by investigator, • AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study intervention. • Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing., • Predose and postdose concentrations of PF-08634404, • Incidence of ADA against PF-08634404, • Mean score change from baseline in participant reported GHS/QoL, function, and symptoms per EORTC QLQ-C30 • Mean score change from baseline in participant reported function and symptoms scales per EORTC QLQ-CR29, • Time to definitive deterioration in participant reported GHS/QoL, function and symptoms per EORTC QLQ-C30 • Time to definitive deterioration in participant reported function and symptoms per EORTC QLQ-CR29	—

Measure

Time frame

• PFS by investigator • ORR by BICR and by investigator • DOR by BICR and by investigator • PFS2 (PFS after next-line therapy) by investigator, • AEs as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), timing, seriousness, and relationship to study intervention. • Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v5.0), and timing., • Predose and postdose concentrations of PF-08634404, • Incidence of ADA against PF-08634404, • Mean score change from baseline in participant reported GHS/QoL, function, and symptoms per EORTC QLQ-C30 • Mean score change from baseline in participant reported function and symptoms scales per EORTC QLQ-CR29, • Time to definitive deterioration in participant reported GHS/QoL, function and symptoms per EORTC QLQ-C30 • Time to definitive deterioration in participant reported function and symptoms per EORTC QLQ-CR29

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Outcome results

None listed