Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Appendiceal Neoplasms

Cecal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Cecal Diseases

Intestinal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Nintedanib

Protein Kinase Inhibitors

Enzyme Inhibitors

nintedanib

Jimmy J Hwang, MD

The purpose of this trial is to evaluate the disease control rate of nintedanib in subjects with metastatic appendiceal cancer for whom initial fluoropyrimidine-based chemotherapy has failed. Based on previous studies, the anticancer activity of nintedanib in lung and ovarian cancer trials, along with the similarities between appendiceal and colorectal cancer and potentially ovarian cancer, warrant additional investigation for the optimal treatment of metastatic appendiceal carcinomas.

The primary study objective is to evaluate the disease control rate. The secondary study objectives are to evaluate safety and toxicity, objective response rate, overall and 6-month progression free survival, and overall survival. Exploratory study objectives include evaluation of serum and ascites VEGF, hypertension, and paracentesis frequency in subjects with ascites at study entry.

LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma

The disease control rate is the proportion of those subjects with complete response, partial response, or stable disease, as defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Per RECIST 1.1 criteria for target lesions assessed by radiologic evaluation of CT and tumor measurements: Complete Response (CR), Disappearance of all target and non-target lesions, any pathological lymph nodes reduced in short axis to \<10 mm; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor PD; Disease Control Rate (DCR) = CR + PR + SD.

Overall survival was defined as the duration from the start of nintedanib treatment to the date of death from any cause; subjects who are alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive. Median overall survival was estimated using Kaplan-Meier methods. No formal comparative statistical analysis of overall survival was performed due to low accrual.

Progression-free survival was defined as the duration from the start of nintedanib treatment to the first occurrence of either progressive disease or death; disease progression was objectively determined per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1) or subjectively determined by the investigator. Per RECIST 1.1 criteria for target lesions assessed by radiologic evaluation of CT and tumor measurements: Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter of target lesions (at least 5 mm), or a measurable increase or progression in a non-target lesion, or the appearance of new lesions. Median progression-free survival was estimated using Kaplan-Meier methods. No formal comparative statistical analysis of progression-free survival was performed due to low accrual.

The average daily dose of nintedanib is calculated as the total cumulative dose (in mg) of nintedanib administered divided by the number of 28-day cycles on nintedanib treatment. Prescribed daily dose of nintedanib is 400 mg.

Boehringer Ingelheim

Wake Forest University Health Sciences

The attribution and severity of adverse events were classified and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Subjects received 200 mg oral nintedanib, taken twice daily.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Ascites present at baseline

Five subjects enrolled to the study at their initiations of nintedanib therapy.

Danielle M Boselli

Subjects enrolled to the study at their initiations of nintedanib therapy and had measurable disease at baseline; four of five enrolled subjects had measurable disease at baseline.

Disease Control Rate

All five enrolled subjects are evaluable for the analysis of overall survival.

Overall Survival

All five enrolled subjects are evaluable for the analysis of progression-free survival.

Progression-free Survival

Enrolled subjects returning bottles for drug accountability are included in the reporting of average daily dose of nintedanib.

Treatment Administration of Nintedanib, as Measured by Average Daily Dose of Nintedanib.

Participants received 200 mg oral nintedanib, taken twice daily.

Spots Global Cancer Trial Database for LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma

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