CompletedNCT01234402Updated Aug 14, 2019Results posted

Study of Icrucumab (IMC-18F1) or Ramucirumab Drug Product (DP) in Combination With Capecitabine or Capecitabine on Previously Treated Breast Cancer Patients

A Phase 2 interventional study of Ramucirumab DP and IMC-18F1 in Breast Cancer, sponsored by Eli Lilly and Company. Completed at 23 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-14.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 153
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

An open-label, multicenter, randomized, Phase 2 trial in which participant with unresectable, locally advanced or metastatic breast cancer who have been previously treated with anthracycline and taxane therapy receive ramucirumab DP or Icrucumab (IMC-18F1) administered on an every-21-day cycle (in combination with oral capecitabine therapy; capecitabine is administered twice a day on Days 1-14 of each cycle). Approximately 150 participants will be randomized in a 1:1:1 ratio to either ramucirumab DP or Icrucumab (IMC-18F1) in combination with capecitabine (Arm A and Arm B, respectively) or capecitabine monotherapy (Arm C). Randomization will be stratified by triple-negative receptor status (estrogen receptor-negative, progesterone receptor-negative, and human epidermal growth factor receptor-2 [HER2/neu]-negative) (yes/no) and receipt of prior antiangiogenic therapy.

Treatment with the study medication(s) will continue until disease progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision. Capecitabine dose reductions in the setting of significant myelosuppression, hand-and-foot syndrome, or diarrhea will be required.

Conditions studied

Breast Cancer

Browse trials for

Breast Neoplasms 12,544

Keywords

Breast Cancer

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 153 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

The participant has histologically or cytologically confirmed breast cancer which at the time of study entry is either Stage III disease not amenable to curative therapy or Stage IV disease
Has measurable or nonmeasurable disease
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Has received prior anthracycline therapy
Has received prior taxane therapy
Participants with human epidermal growth factor receptor-2 (HER2) positive disease must have progressed on or following trastuzumab
Participants with hormone receptor-positive disease must have progressed on or following hormone therapy
Has received ≤ 3 prior chemotherapy regimens in any setting (a regimen is defined as any agent[s] that has been administered for more than 1 cycle; sequential neoadjuvant/adjuvant treatment is considered 1 regimen)
Has completed any prior radiotherapy ≥ 4 weeks prior to randomization
Has completed any prior hormonal therapy ≥ 2 weeks prior to randomization
Has adverse events (AEs) that have resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v 4.0) from all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy,or hormonal therapy
Has adequate hematologic, coagulation, hepatic and renal function
Does not have:
- cirrhosis at a level of Child-Pugh B (or worse) or
- cirrhosis (any degree) and a history of hepatic encephalopathy or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
Has urinary protein is ≤ 1+ on dipstick or routine urinalysis; if urine protein ≥ 2+, a 24-hour urine collection must demonstrate \< 1000 mg of protein in 24 hours to allow participation in the study
Agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study medication

Exclusion criteria

Exclusion Criteria:

Has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer, curatively treated cervical carcinoma in situ, or other noninvasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that there has been a disease-free interval for > 3 years
Has a known sensitivity to capecitabine, any of its components, or other drugs formulated with polysorbate 80
Has a known sensitivity to 5-fluorouracil (5-FU)
Has a known dihydropyrimidine dehydrogenase deficiency
Has received prior capecitabine treatment for advanced breast cancer
Has received investigational therapy within 2 weeks prior to randomization
Has received bevacizumab within 4 weeks prior to randomization
Has received more than 1 prior antiangiogenic agent for breast cancer
Has a known sensitivity to agents of similar biologic composition as ramucirumab DP or Icrucumab (IMC-18F1), or other agents that specifically target vascular endothelial growth factor (VEGF)
Has an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention
Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
Has experienced a Grade ≥ 3 bleeding event within 3 months prior to randomization
Is receiving prophylactic or therapeutic anticoagulation with warfarin or any other oral anticoagulant
Has an uncontrolled intercurrent illness, including, but not limited to uncontrolled hypertension, symptomatic anemia, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorder in the opinion of the investigator
Has experienced any arterial thrombotic or thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident within 6 months prior to randomization
Has brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease
Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy
Has received a prior allogeneic organ or tissue transplantation
Has undergone major surgery within 4 weeks prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization
Has had a serious nonhealing wound, ulcer, or bone fracture within 4 weeks prior to randomization
Has known HIV or AIDS infection
Has an elective or planned major surgery to be performed during the course of the trial
Participant is pregnant or lactating

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 153 participants (actual)

Study arms

Experimental
Ramucirumab DP + Capecitabine
Cycles repeat until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant.
Biological: Ramucirumab DP · Drug: Capecitabine
Experimental
Icrucumab + Capecitabine
Cycles repeat until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant.
Biological: IMC-18F1 · Drug: Capecitabine
Active comparator
Capecitabine*
Crossover Study: \* At the discretion of the investigator, participants will be eligible to receive either ramucirumab DP or Icrucumab (IMC-18F1) in combination with capecitabine, after radiographic disease progression while on capecitabine. The investigator will decide which investigational product will be given. Cycles repeat every 21 days until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant.
Drug: Capecitabine

Interventions

BiologicalRamucirumab DP
10 mg/kg I.V. Day 1 of every-21-day cycle
Also known as: IMC-1121B, LY3009806
BiologicalIMC-18F1
12 mg/kg I.V. Days 1 and 8 of every-21-day cycle
Also known as: Icrucumab, LY3012212
DrugCapecitabine
1000 mg/m\^2 orally Twice a day for 14 days

What researchers measure

Primary outcomes

Progression-Free Survival (PFS)
PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 millimeter (mm) and the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up, or had missed 2 or more scheduled tumor assessments were censored at the day of their last adequate tumor assessment.
Time frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 97 weeks)

Secondary outcomes

Overall Survival (OS)
Overall survival is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive.
Time frame: From Date of Randomization until Death Due to Any Cause (Up To 160 weeks)
Percentage of Participants With Objective Response Rate (ORR)
The ORR is the number of all participants with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1 from the start of the treatment until disease progression/recurrence. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm and the appearance of ≥1 new lesions was progression.
Time frame: From Date of Randomization until Disease Progression/Recurrence (Up to 97 weeks)
Duration of Response
Duration of response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the criteria for progressive disease (PD) is met (taking as a reference for PD that smallest measurement recorded since the treatment started), or death, is objectively documented.CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.PD defined as ≥20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or the appearance of 1 or more new lesions was considered progression.
Time frame: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 97 weeks)
Number of Participants With Adverse Events (AEs)
Adverse event (AE) will be regarded as treatment-emergent if onset date occurs any time on or after the administration of the first dose of study treatment up to 30 days after the last dose of study treatment (or up to any time if related to study treatment); or it occurs prior to first dose date and worsens while on therapy or up to 30 days after the last dose of study treatment (or up to any time if related to study treatment). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Up To 160 Weeks
Number of Participants With Serious Adverse Events (SAEs)
SAE was defined as any untoward medical occurrence that at any dose: Resulted in death; Was life-threatening; Required inpatient hospitalization or caused prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect; Required intervention to prevent permanent impairment/damage; Was an important medical event (defined as a medical event that may not have been immediately life-threatening or resulted in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention to prevent one of the other serious outcomes listed in the definition above). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Time frame: Up To 160 Weeks
Maximum Concentration (Cmax) Ramucirumab Drug Product (DP) or Icrucumab
Time frame: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab
Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab.
Time frame: Cycle 2,4,6,8,0,12,14,16,18,22: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Area Under the Concentration Versus Time Curve From Time Zero to Infinity of Ramucirumab or Icrucumab
Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity of Ramucirumab and Icrucumab.
Time frame: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Terminal Half-life (t½) of Ramucirumab or Icrucumab
Terminal half-life (t½) of Ramucirumab and Icrucumab.
Time frame: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Clearance (Cl) of Ramucirumab or Icrucumab
Clearance (Cl) of Ramucirumab and Icrucumab.
Time frame: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Volume of Distribution at Steady State (Vss) of Ramucirumab or Icrucumab
Volume of Distribution at Steady State (Vss) of Ramucirumab and Icrucumab.
Time frame: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Number of Participants With Anti-Ramucirumab and Anti-Icrucumab Antibodies
Time frame: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion

Results

Posted Aug 14, 2019

Participant flow

Participants in Capecitabine arm were allowed to cross-over to ramucirumab or icrucumab in combination with capecitabine, after radiographic disease progression while on capecitabine.

Participant flow — Overall Study
Milestone	Ramucirumab + Capecitabine	Icrucumab + Capecitabine	Capecitabine
Started	52	51	50
Received at least one dose of study drug	52	49	49
Capecitabine crossover to ramucirumab	0	0	29
Capecitabine crossover to icrucumab	0	0	1
Completed	51	45	42
Not completed	1	6	8
Withdrew: Lost to follow-up	0	1	3
Withdrew: Withdrawal by subject	1	3	4
Withdrew: Never treated: death	0	0	1
Withdrew: Never treated: withdrawal by subject	0	1	0
Withdrew: Never treated: insurance denied xeloda	0	1	0

Outcome measures

PrimaryProgression-Free Survival (PFS)

PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 millimeter (mm) and the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up, or had missed 2 or more scheduled tumor assessments were censored at the day of their last adequate tumor assessment.

Time frame:: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 97 weeks)
Reported as:: Median · Weeks

Progression-Free Survival (PFS)
Weeks	Ramucirumab + Capecitabine	Icrucumab + Capecitabine	Capecitabine
Progression-Free Survival (PFS)	22.1 (12.1 to 36.1)	7.3 (6.3 to 13.0)	19.0 (12.1 to 24.3)

Statistical analysis

Ramucirumab + Capecitabine vs Capecitabine · Log Rank · p = 0.1315 · Hazard ratio (hr): 0.691 · 95% CI 0.429 to 1.114
Icrucumab + Capecitabine vs Capecitabine · Log Rank · p = 0.0851 · Hazard ratio (hr): 1.480 · 95% CI 0.938 to 2.335

SecondaryOverall Survival (OS)

Overall survival is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive.

Time frame:: From Date of Randomization until Death Due to Any Cause (Up To 160 weeks)
Reported as:: Median · Weeks

Overall Survival (OS)
Weeks	Ramucirumab + Capecitabine	Icrucumab + Capecitabine	Capecitabine
Overall Survival (OS)	67.4 (41.3 to 82.6)	62.1 (41.0 to 84.0)	71.6 (57.4 to 89.7)

Statistical analysis

Ramucirumab + Capecitabine vs Capecitabine · Log Rank · p = 0.0283 · Hazard ratio (hr): 1.833 · 95% CI 1.060 to 3.169
Icrucumab + Capecitabine vs Capecitabine · Log Rank · p = 0.1550 · Hazard ratio (hr): 1.468 · 95% CI 0.862 to 2.501

SecondaryPercentage of Participants With Objective Response Rate (ORR)

The ORR is the number of all participants with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1 from the start of the treatment until disease progression/recurrence. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm and the appearance of ≥1 new lesions was progression.

Time frame:: From Date of Randomization until Disease Progression/Recurrence (Up to 97 weeks)
Reported as:: Number · Percentage of Participants

Percentage of Participants With Objective Response Rate (ORR)
Percentage of Participants	Ramucirumab + Capecitabine	Icrucumab + Capecitabine	Capecitabine
Percentage of Participants With Objective Response Rate (ORR)	28.8 (17.1 to 43.1)	20.4 (10.2 to 34.3)	34.7 (21.7 to 49.6)

Statistical analysis

Ramucirumab + Capecitabine vs Capecitabine · Fisher Exact · p = 0.6691
Icrucumab + Capecitabine vs Capecitabine · Fisher Exact · p = 0.1743

SecondaryDuration of Response

Duration of response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the criteria for progressive disease (PD) is met (taking as a reference for PD that smallest measurement recorded since the treatment started), or death, is objectively documented.CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.PD defined as ≥20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or the appearance of 1 or more new lesions was considered progression.

Time frame:: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 97 weeks)
Reported as:: Median · weeks

Duration of Response
weeks	Ramucirumab + Capecitabine	Icrucumab + Capecitabine	Capecitabine
Duration of Response	43.1 (12.0 to 49.0)	20.1 (1.9 to 33.9)	17.1 (6.4 to 30.7)

SecondaryNumber of Participants With Adverse Events (AEs)

Adverse event (AE) will be regarded as treatment-emergent if onset date occurs any time on or after the administration of the first dose of study treatment up to 30 days after the last dose of study treatment (or up to any time if related to study treatment); or it occurs prior to first dose date and worsens while on therapy or up to 30 days after the last dose of study treatment (or up to any time if related to study treatment). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Time frame:: Up To 160 Weeks
Reported as:: Count of participants · Participants

Number of Participants With Adverse Events (AEs)
Participants	Ramucirumab + Capecitabine	Icrucumab + Capecitabine	Capecitabine
Number of Participants With Adverse Events (AEs)	52	49	48

SecondaryNumber of Participants With Serious Adverse Events (SAEs)

SAE was defined as any untoward medical occurrence that at any dose: Resulted in death; Was life-threatening; Required inpatient hospitalization or caused prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect; Required intervention to prevent permanent impairment/damage; Was an important medical event (defined as a medical event that may not have been immediately life-threatening or resulted in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention to prevent one of the other serious outcomes listed in the definition above). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Time frame:: Up To 160 Weeks
Reported as:: Count of participants · Participants

Number of Participants With Serious Adverse Events (SAEs)
Participants	Ramucirumab + Capecitabine	Icrucumab + Capecitabine	Capecitabine
Number of Participants With Serious Adverse Events (SAEs)	20	25	6

SecondaryMaximum Concentration (Cmax) Ramucirumab Drug Product (DP) or Icrucumab

Time frame:: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Reported as:: Geometric mean · Microgram per milliliter

Maximum Concentration (Cmax) Ramucirumab Drug Product (DP) or Icrucumab
Microgram per milliliter	Ramucirumab + Capecitabine	Icrucumab + Capecitabine
Maximum Concentration (Cmax) Ramucirumab Drug Product (DP) or Icrucumab	308 ± 25	—

SecondaryMinimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab

Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab.

Time frame:: Cycle 2,4,6,8,0,12,14,16,18,22: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Reported as:: Geometric mean · Micro gram per milliliter

Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab
Micro gram per milliliter	Ramucirumab + Capecitabine	Icrucumab + Capecitabine
Cycle 2	23.7 ± 58	—
Cycle 4	80.6 ± 67	—
Cycle 6	44.7 ± 83	—
Cycle 8	65.8 ± 43	—
Cycle 10	66.8 ± 37	—
Cycle 12	74.3 ± 38	—
Cycle 14	62.5	—
Cycle 16	50.5	—
Cycle 18	50.5	—
Cycle 22	55.0	—

SecondaryArea Under the Concentration Versus Time Curve From Time Zero to Infinity of Ramucirumab or Icrucumab

Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity of Ramucirumab and Icrucumab.

Time frame:: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Reported as:: Geometric mean · microgram*hour/mL

Area Under the Concentration Versus Time Curve From Time Zero to Infinity of Ramucirumab or Icrucumab
microgram*hour/mL	Ramucirumab + Capecitabine	Icrucumab + Capecitabine
Area Under the Concentration Versus Time Curve From Time Zero to Infinity of Ramucirumab or Icrucumab	54400 ± 42	—

SecondaryTerminal Half-life (t½) of Ramucirumab or Icrucumab

Terminal half-life (t½) of Ramucirumab and Icrucumab.

Time frame:: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Reported as:: Geometric mean · Days

Terminal Half-life (t½) of Ramucirumab or Icrucumab
Days	Ramucirumab + Capecitabine	Icrucumab + Capecitabine
Terminal Half-life (t½) of Ramucirumab or Icrucumab	6.80 (5.22 to 8.57)	—

SecondaryClearance (Cl) of Ramucirumab or Icrucumab

Clearance (Cl) of Ramucirumab and Icrucumab.

Time frame:: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Reported as:: Geometric mean · Liters per hour

Clearance (Cl) of Ramucirumab or Icrucumab
Liters per hour	Ramucirumab + Capecitabine	Icrucumab + Capecitabine
Clearance (Cl) of Ramucirumab or Icrucumab	0.0141 ± 34	—

SecondaryVolume of Distribution at Steady State (Vss) of Ramucirumab or Icrucumab

Volume of Distribution at Steady State (Vss) of Ramucirumab and Icrucumab.

Time frame:: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Reported as:: Geometric mean · Liters

Volume of Distribution at Steady State (Vss) of Ramucirumab or Icrucumab
Liters	Ramucirumab + Capecitabine	Icrucumab + Capecitabine
Volume of Distribution at Steady State (Vss) of Ramucirumab or Icrucumab	3.17 ± 18	—

SecondaryNumber of Participants With Anti-Ramucirumab and Anti-Icrucumab Antibodies

Time frame:: Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion
Reported as:: Count of participants · Participants

Number of Participants With Anti-Ramucirumab and Anti-Icrucumab Antibodies
Participants	Ramucirumab + Capecitabine	Icrucumab + Capecitabine
Treatment emergent antibody	0	—
Neutralizing antibody	0	—

Adverse events

Collected over Up To 160 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ramucirumab + Capecitabine	—	20/52 (38.5%)	51/52 (98.1%)
Icrucumab + Capecitabine	—	25/49 (51%)	49/49 (100%)
Capecitabine	—	6/49 (12.2%)	48/49 (98%)
Crossover to Ramucirumab DP + Capecitabine	—	5/29 (17.2%)	29/29 (100%)
Crossover to Icrucumab + Capecitabine	—	0/1 (0%)	1/1 (100%)

Most frequent serious events

Showing 10 of 72

Most frequent serious events
Event	Ramucirumab + Capecitabine	Icrucumab + Capecitabine	Capecitabine	Crossover to Ramucirumab DP + Capecitabine	Crossover to Icrucumab + Capecitabine
Pleural effusionRespiratory, thoracic and mediastinal disorders	2/52	8/49	0/49	0/29	0/1
Pericardial effusionCardiac disorders	0/52	4/49	0/49	0/29	0/1
DehydrationMetabolism and nutrition disorders	2/52	4/49	0/49	1/29	0/1
DyspnoeaRespiratory, thoracic and mediastinal disorders	4/52	3/49	0/49	1/29	0/1
AscitesGastrointestinal disorders	3/52	0/49	0/49	0/29	0/1
AnaemiaBlood and lymphatic system disorders	0/52	2/49	0/49	0/29	0/1
DiarrhoeaGastrointestinal disorders	0/52	2/49	1/49	0/29	0/1
NauseaGastrointestinal disorders	0/52	2/49	1/49	0/29	0/1
VomitingGastrointestinal disorders	0/52	2/49	2/49	1/29	0/1
PneumoniaInfections and infestations	0/52	2/49	1/49	0/29	0/1

Most frequent other events

Showing 10 of 113

Most frequent other events
Event	Ramucirumab + Capecitabine	Icrucumab + Capecitabine	Capecitabine	Crossover to Ramucirumab DP + Capecitabine	Crossover to Icrucumab + Capecitabine
AnaemiaBlood and lymphatic system disorders	7/52	14/49	12/49	3/29	1/1
Vision blurredEye disorders	2/52	1/49	0/49	3/29	1/1
Abdominal pain upperGastrointestinal disorders	3/52	3/49	3/49	3/29	1/1
ChillsGeneral disorders	4/52	2/49	2/49	3/29	1/1
Face oedemaGeneral disorders	1/52	9/49	0/49	0/29	1/1
Non-cardiac chest painGeneral disorders	1/52	2/49	1/49	0/29	1/1
Oedema peripheralGeneral disorders	13/52	19/49	6/49	5/29	1/1
Neutrophil count decreasedInvestigations	4/52	2/49	2/49	1/29	1/1
Decreased appetiteMetabolism and nutrition disorders	17/52	11/49	10/49	6/29	1/1
ArthralgiaMusculoskeletal and connective tissue disorders	11/52	2/49	8/49	3/29	1/1

Baseline characteristics

All randomized participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)	Ramucirumab + Capecitabine	Icrucumab + Capecitabine	Capecitabine	Total
Mean	55.2 ± 10.75	51.1 ± 11.54	53.5 ± 11.12	53.3 ± 11.19

Sex: Female, Male
Sex: Female, Male(Participants)	Ramucirumab + Capecitabine	Icrucumab + Capecitabine	Capecitabine	Total
Female	52	48	49	149
Male	0	1	0	1

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Ramucirumab + Capecitabine	Icrucumab + Capecitabine	Capecitabine	Total
Hispanic or Latino	2	3	1	6
Not Hispanic or Latino	49	44	45	138
Unknown or Not Reported	1	2	3	6

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Ramucirumab + Capecitabine	Icrucumab + Capecitabine	Capecitabine	Total
American Indian or Alaska Native	0	1	0	1
American Indian or Alaska Native,White	0	0	1	1
Asian	2	1	1	4
Black or African American	13	8	4	25
Native Hawaiian or Other Pacific Islander	0	0	1	1
White	36	37	39	112
White, Other	0	0	1	1
Other	1	2	2	5

Study locations

23 sites

ImClone Investigational Site
Scottsdale, Arizona 85259, United States
ImClone Investigational Site
Los Angeles, California 90033, United States
ImClone Investigational Site
Jacksonville, Florida 32224, United States
ImClone Investigational Site
Atlanta, Georgia 30322, United States
ImClone Investigational Site
Augusta, Georgia 30912, United States
ImClone Investigational Site
Chicago, Illinois 60611, United States
ImClone Investigational Site
Indianapolis, Indiana 46202, United States
ImClone Investigational Site
Baton Rouge, Louisiana 70809, United States
ImClone Investigational Site
Bronx, New York 10461, United States
ImClone Investigational Site
New York, New York 10021, United States
ImClone Investigational Site
Stony Brook, New York 11794, United States
ImClone Investigational Site
Washington, North Carolina 27889, United States
ImClone Investigational Site
Cincinnati, Ohio 45242, United States
ImClone Investigational Site
Columbus, Ohio 43219, United States
ImClone Investigational Site
Dallas, Texas 75390, United States
ImClone Investigational Site
San Antonio, Texas 78229, United States
ImClone Investigational Site
Salt Lake City, Utah 84106, United States
ImClone Investigational Site
Richmond, Virginia 23230, United States
ImClone Investigational Site
Spokane, Washington 99208, United States
ImClone Investigational Site
Morgantown, West Virginia 26506, United States
ImClone Investigational Site
Calgary, Alberta T2N 4N2, Canada
ImClone Investigational Site
Edmonton, Alberta T6G 1Z2, Canada
ImClone Investigational Site
Toronto, Ontario M4N 3M5, Canada

References and documents

Publications

Vahdat LT, Layman R, Yardley DA, Gradishar W, Salkeni MA, Joy AA, Garcia AA, Ward P, Khatcheressian J, Sparano J, Rodriguez G, Tang S, Gao L, Dalal RP, Kauh J, Miller K. Randomized Phase II Study of Ramucirumab or Icrucumab in Combination with Capecitabine in Patients with Previously Treated Locally Advanced or Metastatic Breast Cancer. Oncologist. 2017 Mar;22(3):245-254. doi: 10.1634/theoncologist.2016-0265. Epub 2017 Feb 20. PubMed 28220020 ↗

Individual participant data

Plan to share: Yes — Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01234402
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Nov 4, 2010
Start date: Mar 2011
Primary completion: Oct 2013
Completion: Jul 2017
Results posted: Aug 14, 2019
Last update: Aug 14, 2019

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Study of Icrucumab (IMC-18F1) or Ramucirumab Drug Product (DP) in Combination With Capecitabine or Capecitabine on Previously Treated Breast Cancer Patients

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