A Study of Ramucirumab and Docetaxel in Participants With Solid Tumors

NCT01567163 | Completed Phase 2 Results

• 3 other identifiers: 14434CP12-0713I4T-IE-JVCC
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Malignant Solid Tumor

Keywords

Advanced Malignant Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  Cycle 2: 0, 1, 1.5, 2, 3, 5, 7, 24, 48 and 72 hours post docetaxel infusion

Secondary Outcomes (3)

• Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies

  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

  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

  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

Study Arms (1)

ramucirumab (IMC-1121B) and docetaxel

EXPERIMENTAL

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

Interventions

Ramucirumab BIOLOGICAL

ramucirumab 10 milligrams/kilogram (mg/kg) intravenous infusion, administered on Day 1 of 3-week cycle

Also known as: IMC-1121B, LY3009806

ramucirumab (IMC-1121B) and docetaxel

Docetaxel DRUG

docetaxel 75 milligrams/square meter (mg/m\^2) intravenous infusion administered on Day 1 of each 3-week cycle

ramucirumab (IMC-1121B) and docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has histologic or cytologic documentation of a malignant solid tumor
• Participant has an advanced solid tumor that is resistant to standard therapy or for which no standard therapy is available
• Participant 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.
• Participant has resolution to Grade ≤ 1 (except where otherwise stated in this eligibility criteria) by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v 4.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy
• Participant has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
• Participant has adequate hematologic function (absolute neutrophil count \[ANC\] ≥ 1500 cells/liter (cells/L), hemoglobin ≥ 10 grams/deciliter (g/dL), and platelet count ≥ 100,000 cells/microliter (cells/mcL)\]. Blood transfusion is allowed but must be completed 48 hours before study drug administration.
• Participant has adequate hepatic function (bilirubin ≤ 1.5 times the upper limit of normal \[x ULN\], aspartate transaminase \[AST\] and alanine transaminase \[ALT\] ≤ 1.5 x ULN)
• Participant has serum creatinine ≤ 1.5 x ULN. If serum creatinine \> 1.5 x ULN, the calculated creatinine clearance \[CrCl\] should be ≥ 40 milliliters/minute (mL/min)
• Participant's urinary protein is \<2+ on dipstick or routine urinalysis (UA) at study entry
• Participant 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
• Women with childbearing potential must have a negative serum or urine pregnancy test. Eligible participants of reproductive potential (both sexes) agree to use adequate method of contraception during the study period and for 12 weeks after the last dose of study medication.

You may not qualify if:

• Has a known allergy or hypersensitivity to any of the treatment components
• 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 therapeutic 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 prior to first dose of study medication
• Is receiving concurrent treatment with another anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy (except for androgen deprivation therapy for prostate cancer), 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (6)

ImClone Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

ImClone Investigational Site

Detroit, Michigan, 48202, United States

Location

ImClone Investigational Site

New Brunswick, New Jersey, 08901, United States

Location

ImClone Investigational Site

Huntersville, North Carolina, 28078, United States

Location

ImClone Investigational Site

Cleveland, Ohio, 44195, United States

Location

ImClone Investigational Site

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Ramucirumab; Docetaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: March 30, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2014
• Last Updated: October 16, 2014
• Results First Posted: June 18, 2014

Record last verified: 2014-10

Locations

US (6)