Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Rectal Neoplasms

Adenocarcinoma

Colonic Neoplasms

Disease Progression

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Antineoplastic Agents

Herbal and Botanical

Antibodies

Antibodies, Monoclonal

Irinotecan

Fluorouracil

Oxaliplatin

Immunoglobulins

Ramucirumab

Angiogenesis Inhibitors

Growth Inhibitors

Cola

Icrucumab

Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W)

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mFOLFOX-6

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)

The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.

The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid \[FA\] + fluorouracil \[5-FU\] + oxaliplatin \[mFOLFOX-6\])-based regimens, as second-line therapy.

During 2010, there has been an identified shortage of injectable folinic acid (FA) in the United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate continuity of participant care.

A Study of Ramucirumab or Icrucumab in Colorectal Cancer

An Open-label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of 5 FU/FA and Oxaliplatin (Modified FOLFOX 6) in Combination With Ramucirumab or IMC-18F1 or Without Investigational Therapy as Second Line Therapy in Patients With Metastatic Colorectal Cancer Following Disease Progression on First Line Irinotecan-based Therapy

PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit.

The ORR is the percentage of participants with Complete Response (CR, the disappearance of target lesions and any pathological lymph nodes \[target or non-target\] taking as reference the baseline sum of diameters in response to treatment) or Partial Response (PR, at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters in response to treatment) according to RECIST v1.1 from the start of the treatment until disease progression.

Overall survival is defined as the time from baseline 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.

DoR was measured from the time measurement criteria are first met for Complete Response or Partial Response or until the first date that the criteria for disease progression or death from any cause. whichever is first recorded. As defined according to RECIST v1.1, CR is the disappearance of all non-nodal target lesions, and PR is the short axes of any target lymph nodes reduced to \< 10 mm and at least a 30% decrease in the sum of the diameters of target lesions including the short axes of any target lymph nodes.)

Maximum concentration (1 hour post end of infusion, Cmax) is the concentration measured in serum.

Trough (prior to infusion, Ctrough) concentrations measured in serum.

Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma after drug infusion.

Cmax is the maximum peak concentration measured in blood plasma after drug infusion.

Cmin is the minimum peak concentration measured in blood plasma after drug infusion.

Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.

A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals.

A sample will be considered positive for anti-icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-icrucumab antibody level seen in healthy untreated individuals.

A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.

Eli Lilly and Company

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

mFOLFOX-6

mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks

FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks

mFOLFOX-6 + Ramucirumab

Ramucirumab : 8 mg/kg I.V. infusion, administered every 2 weeks

mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks

FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks

mFOLFOX-6 + Ramucirumab

mFOLFOX-6 + Icrucumab

Icrucumab: 15 mg/kg I.V. infusion, administered every 2 weeks

mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks

FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks

mFOLFOX-6 + Icrucumab

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mFOLFOX-6 + Ramucirumab

Ramucirumab: 8 mg/kg IV Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mFOLFOX-6 + Icrucumab

Icrucumab: 15 mg/kg IV Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m2 Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Chief Medical Officer

mFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mFOLFOX-6 + Ramucirumab

Ramucirumab: 8 mg/kg IV infusion Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mFOLFOX-6 + Icrucumab

Icrucumab: 15 mg/kg IV Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV infusion Q2W

FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

Modified Intent-to-Treatment (mITT) population includes all the randomized participants who received at least one dose study drug. In mFOLFOX-6, mFOLFOX-6+Ramucirumab and mFOLFOX-6 + Icrucumab, there were 13, 9 and 11 censored participants, respectively.

Progression-Free Survival (PFS)

mFOLFOX-6

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mFOLFOX-6 + Ramucirumab

Ramucirumab: 8 mg/kg IV Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mFOLFOX-6 + Icrucumab

Icrucumab: 15 mg/kg IV Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion Q2W

mITT population includes all the randomized participants who received at least one dose of study drug.

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])

mFOLFOX-6

mFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mFOLFOX-6 + Ramucirumab Ramucirumab: 8 mg/kg IV Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mFOLFOX-6 + Icrucumab

Icrucumab: 15 mg/kg IV Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mITT population includes all the randomized participants who received at least one dose of study drug. In mFOLFOX-6, mFOLFOX-6 + Ramucirumab, and mFOLFOX-6 + Icrucumab there were 12, 11, and 12 censored participants, respectively.

Overall Survival (OS)

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² IV Q2W(or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W

mFOLFOX-6 + Ramucirumab

IMC-1121B: 8 mg/kg IV Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mFOLFOX-6 + Icrucumab

IMC-18F1: 15 mg/kg IV Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mITT population includes all the randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline DoR data. 2 participants were censored in mFOLFOX-6 arm, 2 in mFOLFOX-6 + Ramucirumab arm and 1 in mFOLFOX-6 + Icrucumab.

Duration of Response (DoR)

mFOLFOX-6 + Ramucirumab

IMC-1121B: 8 mg/kg IV Q2W mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

mFOLFOX-6 + Icrucumab

IMC-18F1: 15 mg/kg IV Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

All randomized participants assigned to the mFOLFOX-6 + Ramucirumab or mFOLFOX-6 + Icrucumab who received at least one dose of study drug and had evaluable ramucirumab or icrucumab PK data to calculate Cmax.

Pharmacokinetics (PK): Maximum Concentration (Cmax) at Cycle 5

All randomized participants assigned to the mFOLFOX-6 + Ramucirumab or mFOLFOX-6 + Icrucumab who received at least one dose of study drug and had evaluable Ramucirumab or Icrucumab PK data to calculate Ctrough.

Pharmacokinetics (PK): Trough Serum Concentrations (Ctrough) at Cycle 5

Zero participants analyzed. Outcome Measure (OM) entered incorrectly and no data collected to report.

Maximum Concentration (Cmax) at Day 8

Zero participants analyzed. OM entered incorrectly and no data collected to report.

Maximum Concentration (Cmax) at Day 15

Minimum Concentration (Cmin) at Day 1

Minimum Concentration (Cmin) at Day 4

Minimum Concentration (Cmin) at Day 8

Minimum Concentration (Cmin) at Day 15

mFOLFOX-6 + Ramucirumab

Ramucirumab: 8 mg/kg IV Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks

Participants in mFOLFOX-6 +Ramucirumab who received at least one dose of study drug and had at least 1 post treatment assessment.

Number of Participants With Serum Ramucirumab Antibody Assessment

mFOLFOX-6 + Icrucumab

Icrucumab: 15 mg/kg IV Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion Q2W

Zero participants analyzed. No data collected to report.

Serum Anti-Icrucumab Antibody Assessment

Any TEAE

Any SAE

Any Grade ≥3 AE

Any AE leading to discontinuation (any drug)

mFOLFOX-6 + Ramucirumab

IMC-1121B: 8 mg/kg I.V. infusion, administered every 2 weeks

mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks

FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks

mFOLFOX-6 + Icrucumab Icrucumab: 15 mg/kg I.V. infusion, administered every 2 weeks mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks

Population includes all the randomized participants who received at least one dose study drug.

Number of Participants With Adverse Events

mFOLFOX-6: Oxaliplatin: 85 milligram/meter squared, intravenous (mg/m², IV) infusion every 2 weeks (Q2W)

Folinic acid (FA): 400 mg/m² IV infusion Q2W (or Levo-folinic acid \[LFA\]: 200 mg/m² Q2 weeks if FA is unavailable).

Fluorouracil (5FU): 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W

mFOLFOX-6 + Ramucirumab

Ramucirumab: 8 mg/kg IV Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2 weeks if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W

mFOLFOX-6 + Icrucumab

Icrucumab: 15 mg/kg IV Q2W

mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m2 Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Renal Cell

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Urethral Cancer

Docetaxel

Tubulin Modulators

Antimitotic Agents

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle

Ramucirumab (DP): 10 milligram/kilogram (mg/kg) intravenous (IV) on day 1 of each 21-day cycle

Ramucirumab DP

12 mg/kg I.V. on day 1 and Day 8 of each 21-day cycle

This multicenter trial will enroll participants with metastatic transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis who have had disease progression on first-line platinum-based chemotherapy regimens. Participants will be enrolled into 1 of 3 treatment arms: docetaxel; docetaxel and ramucirumab; or docetaxel and icrucumab.

Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma

An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Docetaxel in Combination With Ramucirumab (IMC-1121B) Drug Product or IMC-18F1 or Without Investigational Therapy as Second-line Therapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Bladder, Urethra, Ureter, or Renal Pelvis Following Disease Progression on First-line Platinum-based Therapy

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.

Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels \[if tumor markers were initially above the upper limit of normal (ULN)\]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)\*100.

The duration of response was measured from the time measurement criteria were first met for a CR or PR (whichever was first recorded) until the first date of objectively documented progressive disease (taking as a reference for progressive disease the smallest measurement recorded since randomization) or the date of death, whichever occurred first. Data for participants who did not relapse or die were censored at the day of their last adequate tumor assessment. Duration of response was estimated by the Kaplan-Meier method.

A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Number of participants with at least one positive titer treatment emergent antibody positive neutralizing antibody detecting. A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals.

A sample will be considered positive for anti-Icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-IMC-Icrucumab antibody level seen in healthy untreated individuals.

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab DP: Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Docetaxel + Ramucirumab DP

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Docetaxel + Icrucumab

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Ramucirumab (DP): 10 mg/kg IV on day 1 of each 21-day cycle

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on day 1 and Day 8 of each 21-day cycle

Canada

United States

Region of Enrollment

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

All randomized participants who received at least one dose of study drug. Participants censored: docetaxel arm = 40; docetaxel and ramucirumab arm = 34; docetaxel and Icrucumab arm = 41.

All randomized participants who received one dose of study drug.

Percentage of Participants Achieving Objective Response Rate (ORR)

All randomized participants received one dose of study drug and had CR or PR.

Duration of Response

Any AE

Number of Participants With Adverse Events (AEs)

Cycle 1

Cycle 2

Cycle 3

Cycle 4

Cycle 6

All randomized participants who received at least one dose of study drug and had evaluable PK data for Ramucirumab and there was no PK data for Docetaxel arm.

Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab

PK: Minimum Concentration (Cmin) Ramucirumab

Cycle 1 Cmax

Cycle 3 Cmax

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 mg/m2 on Day 1 of each 21-day cycle

Icrucumab: 12 mg/kg IV on Day 1 and Day 8 of each 21-day cycle

All randomized participants who received at least one dose of study drug and had evaluable PK data for Icrucumab and there was no PK data for Docetaxel arm.

PK: Cmax Icrucumab

Day 1 Cycle 2

Day 1 Cycle 3

PK: Cmin Icrucumab

All randomized participants who received at least one dose of study drug and had baseline and post baseline anti-ramucirumab antibodies.

Number of Participants With Serum Anti-Ramucirumab Antibody Assessment

Zero participants analyzed. Data not collected.

Number of Participants With Serum Anti-Icrucumab Antibody Assessment

Pharmacodynamics (PD): Change in Circulating Levels of Placental Growth Factor (PlGF)

PD: Change in Circulating Levels of Vascular Endothelial Growth Factor-A (VEGF-A)

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle

PD: Change in Circulating Levels of Vascular Endothelial Growth Factor-B (VEGF-B)

PD: Change in Circulating Levels of Soluble Vascular Endothelial Growth Factor-1 (VEGFR-1)

PD: Change in Circulating Levels of Soluble Vascular Endothelial Growth Factor-2 (VEGFR-2)

Cycles repeat every 3 weeks until disease Progression, unacceptable toxicity, or withdrawal.

Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Ramucirumab or Icrucumab in Colorectal Cancer	NCT01111604	Colon Cancer Rectal Cancer	Ramucirumab Icrucumab mFOLFOX-6	18 Years -	Eli Lilly and Company
A Study of Ramucirumab or Icrucumab in Colorectal Cancer	NCT01111604	Colon Cancer Rectal Cancer	Ramucirumab Icrucumab mFOLFOX-6	18 Years -	Eli Lilly and Company
A Study of Ramucirumab or Icrucumab in Colorectal Cancer	NCT01111604	Colon Cancer Rectal Cancer	Ramucirumab Icrucumab mFOLFOX-6	18 Years -	Eli Lilly and Company
Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma	NCT01282463	Carcinoma of Ur... Urethral Carcin... Carcinoma of Ur... Carcinoma of Re...	Docetaxel Ramucirumab DP Icrucumab	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for icrucumab

Every month we try and update this database with for icrucumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for icrucumab

Every month we try and update this database with for icrucumab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for icrucumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.