CompletedNCT01515306Updated Mar 8, 2022Results posted

A Study of Ramucirumab (IMC-1121B) and Paclitaxel in Participants With Solid Tumors

A Phase 2 interventional study of ramucirumab (IMC-1121B) and paclitaxel in Malignant Solid Tumor, sponsored by Eli Lilly and Company. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-08.

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

Phase: Phase 2
Study type: Interventional
Enrollment: 48
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to investigate whether there are no clinically significant pharmacokinetic effects of concomitant ramucirumab (IMC-1121B) on paclitaxel by investigating the pharmacokinetics (PK) of each in participants with advanced malignant solid tumors.

Part A of this study will investigate the potential of concomitant ramucirumab (IMC-1121B) to affect the pharmacokinetics of paclitaxel. Part B of this study will investigate the pharmacokinetics of ramucirumab (IMC-1121B) as monotherapy.

Conditions studied

Malignant Solid Tumor

Browse trials for

Neoplasms 9,359

Keywords

Advanced Malignant Solid Tumors

In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's enrollment of 48 is close to the median of 50 across 7,250 interventional studies indexed under Neoplasms.

Browse 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

Has histologic or cytologic documentation of a malignant solid tumor
Has an advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available
Part A only: Has had 0-1 prior taxane-containing treatment regimens (including taxane monotherapy), which must have been completed at least 6 months before the first dose of study medication (prior bevacizumab is allowed)
Part B only: Prior bevacizumab- and taxane-containing treatment regimens (including taxane monotherapy) are allowed, provided these regimens have been completed at least 6 months before the first dose of study medication
Has resolution to Grade ≤ 1 of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy, which must not have exceeded Grade 1, by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v 4.0)
Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 - 2
Has adequate hematologic function. Blood transfusion is allowed but must be completed 48 hours before study drug administration
Has adequate hepatic function (bilirubin ≤ 1.5 times the upper limit of normal [ULN], aspartate transaminase [AST] and alanine transaminase [ALT] ≤ 1.5 x ULN
Has serum creatinine ≤ 1.5 x ULN. If serum creatinine > 1.5 x ULN, the calculated creatinine clearance (CrCl) should be ≥ 40 milliliter/minute (mL/min)
Urinary protein is \<2+ on dipstick or routine urinalysis (UA)
Must have adequate coagulation function as defined by an international normalized ratio (INR) of ≤ 1.5 and a partial thromboplastin time (PTT) or an activated PTT (aPTT) ≤ 1.5 x ULN
Eligible participants of reproductive potential agree to use adequate method of contraception during the study period and for 12 weeks after the last dose of study medication

Exclusion criteria

Exclusion Criteria:

Is receiving concomitant therapy with clinically relevant inhibitors or inducers of cytochrome P450, CYP2C8, CYP3AY and/or isoenzymes
Are currently enrolled in, or discontinued within the last 14 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Has received a monoclonal antibody within 42 days prior to first dose of study medication
Has received radiotherapy within 14 days prior to first dose of study medication
Has received cytotoxic chemotherapy within 21 days (6 weeks for nitrosoureas or mitomycin C) prior to first dose of study medication
Has a cardiac left ventricular ejection fraction (LVEF) not within institutional limits of normal on a multigated acquisition scan (MUGA) or echocardiogram
Is receiving concurrent treatment with another anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, radiation therapy, chemoembolization, targeted or other investigational anticancer therapy
Is receiving chronic therapy with nonsteroidal anti-inflammatory agents or other antiplatelet agents. Aspirin use at doses up to 325 milligrams/day (mg/day) and analgesic agents with no or low bleeding risk are permitted
Has a history of uncontrolled hereditary or acquired bleeding or thromboembolic disorders
Has experienced any arterial thromboembolic event, including myocardial infarction (MI), unstable angina stroke or transient ischemic attack (TIA), within 6 months prior to first dose of study medication
Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to first dose of study medication
Has experienced a Grade 3 or 4 hemorrhagic event within 3 months prior to first dose of study medication
Has experienced peripheral neuropathy ≥ Grade 2 at any time prior to study entry
Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
History of gastrointestinal perforation and / or fistulae within 6 months prior to randomization
Has an ongoing or active infection requiring treatment with intravenous antibiotics
Has a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to first dose of study medication
Has uncontrolled hypertension
Has symptomatic congestive heart failure
Has known brain or leptomeningeal disease
Has known positive status for human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome-related illness
Has known active drug or alcohol abuse that would affect participant's ability to comply with study treatment
Has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen
Has had major surgery within 28 days prior to first dose of study medication or subcutaneous venous access device implantation within 7 days prior to first dose of study medication
Has an elective or planned major surgery during the course of the trial
If a primary cancer is non-small-cell lung cancer (NSCLC), participant has intratumor cavitation, radiologically documented evidence of major blood vessel invasion or encasement by cancer, or proximity of cancer to major airways
Has received prior ramucirumab (IMC-1121B) therapy
The participant has:
- cirrhosis at a level of Child-Pugh B (or worse)
- cirrhosis (any degree) and a history of hepatic encephalopathy or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 48 participants (actual)

Study arms

Experimental
Part A: ramucirumab (IMC-1121B) and paclitaxel
Experimental: Part A: ramucirumab (IMC-1121B) and paclitaxel Cycle 1: paclitaxel administered on Day 1 of 2-week cycle. Cycle 2 and beyond : ramucirumab (IMC-1121B) administered on Day 1 and Day 15, paclitaxel administered on Day 1, Day 8 and Day 15 of 4-week cycle.
Biological: ramucirumab (IMC-1121B) · Drug: paclitaxel
Experimental
Part B: ramucirumab (IMC-1121B) and paclitaxel
Cycle 1: ramucirumab (IMC-1121B) administered as monotherapy on Day 1 of 3-week cycle. Cycle 2 and beyond: ramucirumab (IMC-1121B) administered on Day 1 and Day 15, paclitaxel administered on Day 1, Day 8 and Day 15 of 4- week cycle. \*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A.
Biological: ramucirumab (IMC-1121B) · Drug: paclitaxel

Interventions

Biologicalramucirumab (IMC-1121B)
ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) intravenous infusion, administered on Day 1and Day 15 of each 4-week cycle, unless otherwise specified.
Also known as: LY3009806
Drugpaclitaxel
paclitaxel 80 milligrams/square meter (mg/m²) intravenous infusion, administered on Days 1, 8 and 15 of each 4-week cycle, unless otherwise specified.

What researchers measure

Primary outcomes

Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 1
Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.
Time frame: Cycle 1: 0, 1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion
Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 2
Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.
Time frame: Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion
Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 1
Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.
Time frame: Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion
Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 2
Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.
Time frame: Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion
Part B: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] as Monotherapy
Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose.
Time frame: Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72,168, 264, 336, 408, and 504 hours post ramucirumab infusion

Secondary outcomes

Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Paclitaxel
Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose.
Time frame: Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion
Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Paclitaxel
Dose-normalized Cmax was calculated from Cmax divided by the dose.
Time frame: Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion
Part A: Immunogenicity of Ramucirumab in Combination With Paclitaxel - Number of Participants With Anti-Ramucirumab Antibodies
Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline.
Time frame: -1 hour on Day 1 of Cycle 2, and 30 days after last dose of study drug
Part B: Immunogenicity of Ramucirumab as Monotherapy - Number of Participants With Anti-Ramucirumab Antibodies
Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline.
Time frame: 0 hour on Day 1 of Cycle 1, and 30 days after last dose of study drug

Results

Posted Jun 18, 2014

Participant flow

Participant flow — Overall Study
Milestone	Part A: Paclitaxel and Ramucirumab	Part B: Ramucirumab With or Without Paclitaxel
Started	24	16
Received at least 1 dose of study drug	24	16
Cycle 1	24	16
Cycle 2	21	15
Drug-drug interaction population	21	0
Completed	0	2
Not completed	24	14
Withdrew: Adverse event	3	2
Withdrew: Progressive disease	19	9
Withdrew: Withdrawal by subject	1	2
Withdrew: Physician decision	1	1

Outcome measures

PrimaryPart A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 1

Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.

Time frame:: Cycle 1: 0, 1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion
Reported as:: Least squares mean · nanograms*hour/milliliter/milligram

Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 1
nanograms*hour/milliliter/milligram	Part A: Paclitaxel Alone (Cycle 1)
Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 1	29 (24.50 to 34.34)

PrimaryPart A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 2

Time frame:: Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion
Reported as:: Least squares mean · nanograms*hour/milliliter/milligram

Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 2
nanograms*hour/milliliter/milligram	Part A: Paclitaxel + Ramucirumab (Cycle 2)
Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 2	31.67 (26.58 to 37.73)

Statistical analysis

Part A: Paclitaxel + Ramucirumab (Cycle 2) · Mixed Models Analysis · Ratio of geo ls means: 1.09 · 90% CI 0.93 to 1.29Ratio of Geo LS mean is AUC(0-∞) of Cycle 2/Cycle 1.

PrimaryPart A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 1

Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.

Time frame:: Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion
Reported as:: Least squares mean · nanograms/milliliter/milligram

Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 1
nanograms/milliliter/milligram	Part A: Paclitaxel Alone (Cycle 1)
Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 1	18.84 (16.03 to 22.13)

PrimaryPart A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 2

Dose-normalized Cmax was calculated from Cmax divided by the dose. Data presented are Geometric Least Squares (Geo LS) means. Geo LS means were adjusted for cycle, participant and random error.

Time frame:: Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion
Reported as:: Least squares mean · nanograms/milliliter/milligram

Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 2
nanograms/milliliter/milligram	Part A: Paclitaxel + Ramucirumab (Cycle 2)
Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 2	18.30 (15.54 to 21.56)

Statistical analysis

Part A: Paclitaxel + Ramucirumab (Cycle 2) · Mixed Models Analysis · Ratio of geo ls means: 0.97 · 90% CI 0.83 to 1.13Ratio of Geo LS mean is Cmax of Cycle 2/Cycle 1.

PrimaryPart B: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] as Monotherapy

Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose.

Time frame:: Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72,168, 264, 336, 408, and 504 hours post ramucirumab infusion
Reported as:: Geometric mean · micrograms*hour/milliliter/milligram

Part B: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] as Monotherapy
micrograms*hour/milliliter/milligram	Part B: Ramucirumab Alone (Cycle 1)
Part B: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] as Monotherapy	55.3 ± 27

SecondaryPart A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Paclitaxel

Dose-normalized AUC(0-∞) was calculated from AUC(0-∞) divided by the dose.

Time frame:: Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion
Reported as:: Geometric mean · micrograms*hour/milliliters/milligram

Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Paclitaxel
micrograms*hour/milliliters/milligram	Part A: Paclitaxel + Ramucirumab (Cycle 2)
Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Paclitaxel	55.4 ± 27

SecondaryPart A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Paclitaxel

Dose-normalized Cmax was calculated from Cmax divided by the dose.

Time frame:: Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion
Reported as:: Geometric mean · micrograms/milliliter/milligram

Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Paclitaxel
micrograms/milliliter/milligram	Part A: Paclitaxel + Ramucirumab (Cycle 2)
Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Paclitaxel	0.384 ± 31

SecondaryPart A: Immunogenicity of Ramucirumab in Combination With Paclitaxel - Number of Participants With Anti-Ramucirumab Antibodies

Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline.

Time frame:: -1 hour on Day 1 of Cycle 2, and 30 days after last dose of study drug
Reported as:: Count of participants · Participants

Part A: Immunogenicity of Ramucirumab in Combination With Paclitaxel - Number of Participants With Anti-Ramucirumab Antibodies
Participants	Part A: Paclitaxel and Ramucirumab (Cycle 2)
Part A: Immunogenicity of Ramucirumab in Combination With Paclitaxel - Number of Participants With Anti-Ramucirumab Antibodies	0

SecondaryPart B: Immunogenicity of Ramucirumab as Monotherapy - Number of Participants With Anti-Ramucirumab Antibodies

Time frame:: 0 hour on Day 1 of Cycle 1, and 30 days after last dose of study drug
Reported as:: Count of participants · Participants

Part B: Immunogenicity of Ramucirumab as Monotherapy - Number of Participants With Anti-Ramucirumab Antibodies
Participants	Part B: Ramucirumab Alone (Cycle 1)
Part B: Immunogenicity of Ramucirumab as Monotherapy - Number of Participants With Anti-Ramucirumab Antibodies	0

Adverse events

Collected over Baseline, up to 8 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part A: Paclitaxel Alone (Cycle 1)	—	1/24 (4.2%)	18/24 (75%)
Part A: Paclitaxel + Ramucirumab (Cycle 2)	—	6/21 (28.6%)	21/21 (100%)
Part B: Ramucirumab Alone (Cycle 1)	—	0/16 (0%)	8/16 (50%)
Part B: Ramucirumab + Paclitaxel (Cycle 2)	—	6/15 (40%)	14/15 (93.3%)

Most frequent serious events

Showing 10 of 26

Most frequent serious events
Event	Part A: Paclitaxel Alone (Cycle 1)	Part A: Paclitaxel + Ramucirumab (Cycle 2)	Part B: Ramucirumab Alone (Cycle 1)	Part B: Ramucirumab + Paclitaxel (Cycle 2)
ColitisGastrointestinal disorders	0/24	0/21	0/16	1/15
ConstipationGastrointestinal disorders	0/24	0/21	0/16	1/15
Large intestinal obstructionGastrointestinal disorders	0/24	0/21	0/16	1/15
Device related infectionInfections and infestations	0/24	0/21	0/16	1/15
PneumoniaInfections and infestations	0/24	0/21	0/16	1/15
SepsisInfections and infestations	0/24	0/21	0/16	1/15
HyponatraemiaMetabolism and nutrition disorders	0/24	0/21	0/16	1/15
Back painMusculoskeletal and connective tissue disorders	0/24	0/21	0/16	1/15
Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/24	0/21	0/16	1/15
HypoxiaRespiratory, thoracic and mediastinal disorders	0/24	0/21	0/16	1/15

Most frequent other events

Showing 10 of 105

Most frequent other events
Event	Part A: Paclitaxel Alone (Cycle 1)	Part A: Paclitaxel + Ramucirumab (Cycle 2)	Part B: Ramucirumab Alone (Cycle 1)	Part B: Ramucirumab + Paclitaxel (Cycle 2)
FatigueGeneral disorders	1/24	14/21	2/16	4/15
AnaemiaBlood and lymphatic system disorders	3/24	10/21	0/16	3/15
EpistaxisRespiratory, thoracic and mediastinal disorders	0/24	7/21	0/16	6/15
DiarrhoeaGastrointestinal disorders	1/24	8/21	1/16	3/15
HeadacheNervous system disorders	2/24	7/21	0/16	2/15
Decreased appetiteMetabolism and nutrition disorders	1/24	6/21	1/16	3/15
AlopeciaSkin and subcutaneous tissue disorders	0/24	6/21	0/16	1/15
NauseaGastrointestinal disorders	2/24	5/21	4/16	4/15
Oedema peripheralGeneral disorders	0/24	5/21	1/16	4/15
ProteinuriaRenal and urinary disorders	0/24	0/21	2/16	4/15

Baseline characteristics

All participants who received at least 1 dose of study drug.

Age, Categorical
Age, Categorical(Participants)	Part A: Paclitaxel and Ramucirumab	Part B: Ramucirumab With or Without Paclitaxel	Total
<=18 years	0	0	0
Between 18 and 65 years	14	10	24
>=65 years	10	6	16

Sex: Female, Male
Sex: Female, Male(Participants)	Part A: Paclitaxel and Ramucirumab	Part B: Ramucirumab With or Without Paclitaxel	Total
Female	13	9	22
Male	11	7	18

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Part A: Paclitaxel and Ramucirumab	Part B: Ramucirumab With or Without Paclitaxel	Total
Hispanic or Latino	1	0	1
Not Hispanic or Latino	23	16	39
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Part A: Paclitaxel and Ramucirumab	Part B: Ramucirumab With or Without Paclitaxel	Total
American Indian or Alaska Native	0	0	0
Asian	1	1	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	22	15	37
More than one race	1	0	1
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Part A: Paclitaxel and Ramucirumab	Part B: Ramucirumab With or Without Paclitaxel	Total
United States	24	16	40

Study locations

6 sites

ImClone Investigational Site
Ann Arbor, Michigan 48109, United States
ImClone Investigational Site
Detroit, Michigan 48202, United States
ImClone Investigational Site
New Brunswick, New Jersey 08901, United States
ImClone Investigational Site
Cleveland, Ohio 44195, United States
ImClone Investigational Site
Philadelphia, Pennsylvania 19111, United States
ImClone Investigational Site
Seattle, Washington 98109, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01515306
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Jan 24, 2012
Start date: Jul 19, 2012
Primary completion: Mar 20, 2013
Completion: Feb 22, 2021
Results posted: Jun 18, 2014
Last update: Mar 8, 2022

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 ↗

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