Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor decision to end monotherapy development of the compound in breast cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment of patients with biomarker negative (FGF non-aberrant) metastatic breast cancer.
Lucitanib is a selective, orally available tyrosine kinase inhibitor targeting FGFR1-3, VEGFR1-3, and PDGFRα and β, with activity in relevant cell lines and animal models.
The first in human trial of lucitanib demonstrated that daily dosing with lucitanib can provide durable clinical responses in patients with FGFR1- or 11q (FGF3, FGF4, Cyclin D1, or FGF19)-amplified breast cancer. RECIST partial responses (PRs) were also observed in patients not known to have FGF abnormalities.
Based on these results, this study is designed to explore the safety and anti-tumor activity of daily lucitanib in breast cancer patients with and without alterations of the FGF pathway.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Lucitanib (CO-3810) 10 mg daily | Experimental | 10 mg of lucitanib daily in patients with FGFR1-amplified or 11q-amplified metastatic breast cancer. |
|
| Cohort B: Lucitanib (CO-3810) 15 mg daily | Experimental | 15 mg of lucitanib daily in patients with FGFR1-amplified and 11q-amplified metastatic breast cancer. |
|
| Cohort C: Lucitanib (CO-3810) 10 mg daily | Experimental | 10 mg of lucitanib daily in patients with FGFR1 non-amplified and 11q non-amplified metastatic breast cancer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lucitanib | Drug | Lucitanib is a potent, orally available selective inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors (FGFR1-3), vascular endothelial growth factor receptors (VEGFR1-3), and platelet-derived growth factor receptors alpha and beta (PDGFR alpha and beta) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by the Investigator | The primary efficacy endpoint of PFS was calculated as 1+ the number of days from the date of first dose of study drug to disease progression or death due to any cause, whichever occurs first. Patients without a documented event of progression were censored on the date of their last adequate tumor assessment (i.e., radiologic assessment), or the date of randomization if no tumor assessments were performed. Progression events were determined by the investigator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. | From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by RECIST v1.1 | ORR is the percentage of patients with a best response of CR or PR according to RECIST v1.1. The best response is recorded from the start of the treatment (Day 1) until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates | Sedona | Arizona | 86336 | United States | ||
| Comprehensive Blood and Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35844029 | Derived | Liao M, Zhou J, Wride K, Lepley D, Cameron T, Sale M, Xiao J. Population Pharmacokinetic Modeling of Lucitanib in Patients with Advanced Cancer. Eur J Drug Metab Pharmacokinet. 2022 Sep;47(5):711-723. doi: 10.1007/s13318-022-00773-w. Epub 2022 Jul 18. |
Not provided
Not provided
Not provided
178 patients were recruited from 32 sites in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lucitanib (CO-3810) 10 mg QD | 10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons |
| FG001 | Lucitanib (CO-3810) 15 mg QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 27, 2016 | Feb 18, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months |
| Duration of Response (DR) by RECIST v1.1 | DR for complete response (CR) and partial response (PR) was measured from the date that any of these best confirmed responses was first recorded until the first date that PD was objectively documented. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. | From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months |
| Disease Control Rate (DCR) by RECIST v1.1 | The DCR is defined as the percentage of patients with a best response rate of CR, PR, or SD for at least 12 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. | From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months |
| Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - Cmax | The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. Cmax = maximum concentration following administration of lucitanib. | Study Day -7 to Study Day 1, or approximately 8 days |
| Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - Tmax | The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. Tmax = time to maximum concentration following administration of lucitanib | Study Day -7 to Study Day 1, or approximately 8 days |
| Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - AUClast | The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. AUClast = area under the plasma concentration time curve from time 0 to the last quantifiable time point (24 hour) | Study Day -7 to Study Day 1, or approximately 8 days |
| Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - AUCinf | The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. AUCinf = area under the plasma concentration time curve from 0 to infinity | Study Day -7 to Study Day 1, or approximately 8 days |
| Relative Bioavailability Analysis for Tablet vs Capsule - Cmax, AUClast, AUCinf | Relative bioavailability of lucitanib was evaluated by comparison of (log-transformed) AUClast, Cmax and AUCinf of the tablet formulation to the capsule formulation using an analysis of variance (ANOVA) model with treatment as a fixed effect. The geometric means, ratio of the geometric means and 90% confidence intervals (CI) on the ratio of Tablet to Capsule (T:R) were presented for AUClast, Cmax and AUCinf. The CIs on the ratio of untransformed PK parameters were derived through reverse transformation of the 90% CI of the difference in the log scale to the 90% CI of the ratio in the original scale. | Study Day -7 to Study Day 1, or approximately 8 days |
| Overall Survival | Overall survival (OS) is defined as the number of days from the date of first dose of study drug to the date of death (due to any cause). Patients without a known date of death will be censored on the date the patient was last known to be alive. | Cycle 1 Day 1 to date of death, assessed up to 29 months |
| Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Total Score | FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 37 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (10 items) ranging from 0 to 40; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. FACT-B Total Score is derived from adding the five subscale scores. Total possible score ranges from 0 to 148. High scale score represents a better QoL. | From Cycle 1 Day 1 until end of treatment, assessed up to 29 months |
| Bakersfield |
| California |
| 93309 |
| United States |
| Saint Jude Heritage Medical Center | Fullerton | California | 92835 | United States |
| Moores UCSD Cancer Center | La Jolla | California | 92093 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| Cancer Care Associates Medical Group, Inc. | Redondo Beach | California | 90277 | United States |
| University of California San Francisco | San Francisco | California | 94115 | United States |
| Central Coast Medical Oncology Group | Santa Maria | California | 93454 | United States |
| Yale University | New Haven | Connecticut | 06519 | United States |
| University of Miami | Deerfield Beach | Florida | 33442 | United States |
| Memorial West Cancer Center | Hollywood | Florida | 33021 | United States |
| Northwestern University, Robert H. Lurie Comprehensive Cancer Center | Chicago | Illinois | 60611 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Horizon Oncology Center | Lafayette | Indiana | 47905 | United States |
| The Sidney Kimmel Comprehensive Cancer Center at John Hopkins | Baltimore | Maryland | 21231 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89169 | United States |
| Cooper University Hospital | Voorhees Township | New Jersey | 08043 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Weill Cornell Breast Center | New York | New York | 10065 | United States |
| Sciode Medical Associates, PLLC | The Bronx | New York | 10469 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Sarah Cannon Cancer Center | Nashville | Tennessee | 37203 | United States |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Texas Oncology - Austin Central | Austin | Texas | 78731 | United States |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| US Oncology | Houston | Texas | 77024 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lucitanib (CO-3810) 10 mg QD | 10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons |
| BG001 | Lucitanib (CO-3810) 15 mg QD | 15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Number of Prior Anticancer Therapies | Median | Full Range | Therapies |
| |||||||||||||||
| Fibroblast Growth Factor (FGF) Status | FGFR1 and 11q are genes that are amplified in a percentage of breast cancers. Sites were required to submit archival tumor specimens for all enrolled patients for central laboratory confirmation of FGFR1 or 11q amplification status. Patients were categorized based on results indicating FGFR1 amplification, 11q amplification, both FGFR1 and 11q amplification, or non-amplification of either gene (negative). | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) According to RECIST Version 1.1 as Determined by the Investigator | The primary efficacy endpoint of PFS was calculated as 1+ the number of days from the date of first dose of study drug to disease progression or death due to any cause, whichever occurs first. Patients without a documented event of progression were censored on the date of their last adequate tumor assessment (i.e., radiologic assessment), or the date of randomization if no tumor assessments were performed. Progression events were determined by the investigator. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. | Efficacy population: all patients who have received at least one dose of lucitanib and are confirmed as FGR1-, 11q-amplified, or FGF non-amplified per the central laboratory | Posted | Median | 95% Confidence Interval | Days | From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) by RECIST v1.1 | ORR is the percentage of patients with a best response of CR or PR according to RECIST v1.1. The best response is recorded from the start of the treatment (Day 1) until disease progression or recurrence. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. | Efficacy population: all patients who have received at least one dose of lucitanib and are confirmed as FGR1-, 11q-amplified, or FGF non-amplified per the central laboratory | Posted | Number | percentage of participants | From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months |
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DR) by RECIST v1.1 | DR for complete response (CR) and partial response (PR) was measured from the date that any of these best confirmed responses was first recorded until the first date that PD was objectively documented. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. | Efficacy population for patients who had a confirmed CR or PR | Posted | Median | Full Range | Days | From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months |
| ||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) by RECIST v1.1 | The DCR is defined as the percentage of patients with a best response rate of CR, PR, or SD for at least 12 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions, defined by and assessed as: Complete Response (CR), is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum longest diameter since the treatment started. | Efficacy population only | Posted | Number | percentage of patients | From Cycle 1 Day 1 until disease progression or end of treatment, whichever came first, assessed up to 29 months |
| |||||||||||||||||||||||||||||||
| Secondary | Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - Cmax | The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. Cmax = maximum concentration following administration of lucitanib. | PK parameters were assessed in a subset of patients (N=15) | Posted | Mean | Standard Deviation | ng/mL | Study Day -7 to Study Day 1, or approximately 8 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - Tmax | The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. Tmax = time to maximum concentration following administration of lucitanib | PK parameters were assessed in a subset of patients (N=15) | Posted | Median | Full Range | Hours | Study Day -7 to Study Day 1, or approximately 8 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - AUClast | The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. AUClast = area under the plasma concentration time curve from time 0 to the last quantifiable time point (24 hour) | PK parameters were assessed in a subset of patients (N=15) | Posted | Mean | Standard Deviation | h*ng/mL | Study Day -7 to Study Day 1, or approximately 8 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Comparative Pharmacokinetics (PK) of the Lucitanib Capsule Formulation vs. Tablet Formulation - AUCinf | The comparative PK study was a within-patient comparison of tablet and capsule formulations of lucitanib administered orally. PK sampling was performed at specified time points on each of the following two days: • Day -7: patients received a single administration of 10 mg or 15 mg lucitanib tablet formulation • Day 1: patients received a single administration of 10 mg or 15 mg lucitanib in capsule formulation. AUCinf = area under the plasma concentration time curve from 0 to infinity | PK parameters were assessed in a subset of patients (N=15) | Posted | Mean | Standard Deviation | h*ng/mL | Study Day -7 to Study Day 1, or approximately 8 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Relative Bioavailability Analysis for Tablet vs Capsule - Cmax, AUClast, AUCinf | Relative bioavailability of lucitanib was evaluated by comparison of (log-transformed) AUClast, Cmax and AUCinf of the tablet formulation to the capsule formulation using an analysis of variance (ANOVA) model with treatment as a fixed effect. The geometric means, ratio of the geometric means and 90% confidence intervals (CI) on the ratio of Tablet to Capsule (T:R) were presented for AUClast, Cmax and AUCinf. The CIs on the ratio of untransformed PK parameters were derived through reverse transformation of the 90% CI of the difference in the log scale to the 90% CI of the ratio in the original scale. | PK parameters were assessed in a subset of patients (N=15). | Posted | Number | 90% Confidence Interval | Percentage (tablet/capsule) | Study Day -7 to Study Day 1, or approximately 8 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival (OS) is defined as the number of days from the date of first dose of study drug to the date of death (due to any cause). Patients without a known date of death will be censored on the date the patient was last known to be alive. | Intent to treat population by initial treatment and overall | Posted | Median | 95% Confidence Interval | Months | Cycle 1 Day 1 to date of death, assessed up to 29 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Total Score | FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 37 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (10 items) ranging from 0 to 40; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. FACT-B Total Score is derived from adding the five subscale scores. Total possible score ranges from 0 to 148. High scale score represents a better QoL. | Efficacy Population defined as all patients who have received at least one dose of Lucitanib and have at least one post-baseline Investigator Overall Objective Tumor Assessment. 'Overall Number of Participants Analyzed'=participants who completed both a baseline FACT-B assessment and at least one post-baseline assessment. | Posted | Mean | Standard Deviation | units on a scale | From Cycle 1 Day 1 until end of treatment, assessed up to 29 months |
|
Adverse events were reported from the time of first dose of lucitanib through 28 days after last dose protocol-specified treatment administration, up to approximately 30 months. In addition, study procedure-related AEs that occur after signing of the informed consent form and before administration of lucitanib were also collected.
If a patient experiences the same preferred term (system organ class) multiple times, then the patient will be counted only once for that preferred term (system organ class).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lucitanib (CO-3810) 10 mg QD | 10 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons | 5 | 109 | 31 | 109 | 107 | 109 |
| EG001 | Lucitanib (CO-3810) 15 mg QD | 15 mg of lucitanib daily in continuous 28-day treatment cycles until tumor progression, unacceptable toxicity, or withdrawal for other reasons | 7 | 69 | 22 | 69 | 69 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Ammonia increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Renal tubular acidosis | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
All parties agree to submit all manuscripts or abstracts to all other parties 30 days prior to submission. This will enable all parties to protect proprietary information and to provide comments based on information that may not yet be available to other parties. The sponsor may request a delay in publication if there are important intellectual property concerns relating to publication, but does not have the right to suppress publication of the study results indefinitely.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Department | Clovis Oncology, Inc. | +1 415 409 7220 | medinfo@clovisoncology.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2017 | Feb 18, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000595232 | E-3810 |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Black |
|
| Not provided |
|
| Unknown/Not assessed |
|
| Other |
|
| Not Hispanic or Latino |
|
| Not Provided |
|
| FGFR1 |
|
| FGFR1 & 11q |
|
| Negative |
|
| OG002 | All Patients | The total efficacy population analyzed for response |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG002 |
| All Patients |
The total efficacy population analyzed for response |
|
|
|
|
|
|
|
|
| Participants |
|
|
| OG002 | All Patients | The total efficacy population analyzed for response |
|
|