A Phase 2 interventional study of Ramucirumab and Docetaxel 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 2014-10-16.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
The purpose of this study is to assess the effect of concomitant ramucirumab on the pharmacokinetics of docetaxel in participants with advanced malignant solid tumors.
Participants who do not complete both Cycle 1, Day 1, and Cycle 2, Day 1 according to schedule will be replaced for the purpose of analysis; these participants may continue to receive study therapy. No dose reductions, delayed or missed doses are allowed during Cycles 1 and 2.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 22 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →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.
Exclusion Criteria:
Cycle 1: docetaxel administered on Day 1 of 3-week cycle Cycle 2: ramucirumab and docetaxel administered on Day 1 of 3-week cycle Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle Extension Phase: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle
Biological: Ramucirumab · Drug: Docetaxel
ramucirumab 10 milligrams/kilogram (mg/kg) intravenous infusion, administered on Day 1 of 3-week cycle
Also known as: IMC-1121B, LY3009806
docetaxel 75 milligrams/square meter (mg/m\^2) intravenous infusion administered on Day 1 of each 3-week cycle
Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 1
Time frame: Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion
Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 2
Time frame: Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion
Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 1
Time frame: Cycle 1: 0, 1, 1.5, 2, 3, 5, 7, 24, 48, and 72 hours post docetaxel infusion
Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 2
Time frame: Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion
Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies
Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).
Time frame: Cycle 1, Day 1 through Cycle 2, Day 1 and 30 days after last dose of study drug
Pharmacokinetics: Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Docetaxel
Time frame: Cycle 2: 1 hour prior to ramucirumab infusion, 0, 1, 2, 2.5, 3, 4, 6, 8, 25, 49, 73, 169, 265 and 337 hours post ramucirumab infusion
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Docetaxel
Time frame: Cycle 2: 1 hour prior to ramucirumab infusion, 0, 1, 2, 2.5, 3, 4, 6, 8, 25, 49, 73, 169, 265 and 337 hours post ramucirumab infusion
| Milestone | All Participants |
|---|---|
| Started | 22 |
| Received at least 1 dose of study drug | 22 |
| Drug-drug interaction population | 18 |
| Completed | 18 |
| Not completed | 4 |
| Withdrew: Progressive disease | 2 |
| Withdrew: Lost to follow-up | 2 |
| nanograms*hour/milliliter/milligram | Docetaxel (Cycle 1) |
|---|---|
| Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 1 | 13.7 ± 40 |
| nanograms*hour/milliliter/milligram | Docetaxel (Cycle 2) |
|---|---|
| Pharmacokinetics: Dose-Normalized Area Under the Concentration Versus Time Curve of Docetaxel From Time Zero to Infinity [AUC(0-∞)] Following a Single Dose in Cycle 2 | 12.8 ± 30 |
| nanograms/milliliter/milligram | Docetaxel (Cycle 1) |
|---|---|
| Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 1 | 7.66 ± 76 |
| nanograms/milliliter/milligram | Docetaxel (Cycle 2) |
|---|---|
| Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 2 | 8.78 ± 37 |
Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20).
| participants | All Participants |
|---|---|
| Immunogenicity During Study (n=17) | 0 |
| Immunogenicity Post-Treatment (n=5) | 0 |
| micrograms*hour/milliliter (mcg*h/mL) | Ramucirumab |
|---|---|
| Pharmacokinetics: Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Docetaxel | 42400 ± 32 |
| micrograms/milliliter (mcg/mL) | Ramucirumab |
|---|---|
| Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Docetaxel | 303.6 ± 28 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | — | 11/22 (50%) | 20/22 (90.9%) |
| Event | All Participants |
|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 4/22 |
| PyrexiaGeneral disorders | 2/22 |
| PneumoniaInfections and infestations | 2/22 |
| Muscular weaknessMusculoskeletal and connective tissue disorders | 2/22 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/22 |
| NeutropeniaBlood and lymphatic system disorders | 1/22 |
| Vision blurredEye disorders | 1/22 |
| Abdominal painGastrointestinal disorders | 1/22 |
| ConstipationGastrointestinal disorders | 1/22 |
| DiarrhoeaGastrointestinal disorders | 1/22 |
| Event | All Participants |
|---|---|
| NauseaGastrointestinal disorders | 12/22 |
| FatigueGeneral disorders | 9/22 |
| White blood cell count decreasedInvestigations | 9/22 |
| HypertensionVascular disorders | 7/22 |
| AnaemiaBlood and lymphatic system disorders | 6/22 |
| HyperglycaemiaMetabolism and nutrition disorders | 6/22 |
| HyponatraemiaMetabolism and nutrition disorders | 6/22 |
| CoughRespiratory, thoracic and mediastinal disorders | 6/22 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 6/22 |
| Decreased appetiteMetabolism and nutrition disorders | 5/22 |
All participants who received at least 1 dose of ramucirumab or docetaxel.
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 14 |
| >=65 years | 8 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 9 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 22 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 4 |
| White | 17 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| United States | 22 |
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company