A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination with FOLFOX Chemotherapy in Patients with Advanced Solid Tumours

Conditions

Advanced Solid Gastrointestinal Tumors, Cholangiocarcinoma, Colorectal Cancer, Gastric Cancer, Pancreatic Cancer

Brief summary

Incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0;, Incidence of serious adverse events (SAE) and suspected unexpected serious adverse reactions;, Incidence of dose-limiting toxicities (DLT);, Clinically significant changes from baseline in: - Laboratory evaluations (chemistry, hematology, coagulation, urinalysis); - Electrocardiograms; - Vital signs; - Physical examinations; - Eastern Cooperative Oncology Group (ECOG) performance status, Progression Free Survival (PFS), Overall Response Rate (ORR), Overall Survival (OS)

Related papers

No related papers found yet.

Interventions

DRUGFLUOROURACIL

DRUGBOLD-100

DRUGOXALIPLATIN

DRUGFOLINIC ACID

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0;, Incidence of serious adverse events (SAE) and suspected unexpected serious adverse reactions;, Incidence of dose-limiting toxicities (DLT);, Clinically significant changes from baseline in: - Laboratory evaluations (chemistry, hematology, coagulation, urinalysis); - Electrocardiograms; - Vital signs; - Physical examinations; - Eastern Cooperative Oncology Group (ECOG) performance status, Progression Free Survival (PFS), Overall Response Rate (ORR), Overall Survival (OS)	—

Measure

Time frame

Incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0;, Incidence of serious adverse events (SAE) and suspected unexpected serious adverse reactions;, Incidence of dose-limiting toxicities (DLT);, Clinically significant changes from baseline in: - Laboratory evaluations (chemistry, hematology, coagulation, urinalysis); - Electrocardiograms; - Vital signs; - Physical examinations; - Eastern Cooperative Oncology Group (ECOG) performance status, Progression Free Survival (PFS), Overall Response Rate (ORR), Overall Survival (OS)

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Countries

Ireland

Outcome results

None listed