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Malignant Solid TumorPhase 2NCT01567163

A Study of Ramucirumab and Docetaxel in Participants With Solid Tumors

A Phase 2 study testing Ramucirumab and Docetaxel in people with Malignant Solid Tumor, run by Eli Lilly and Company at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Solid Tumor
What is being tested?
Ramucirumab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
6 sitesUnited States
Study dates
Jul 2012to Mar 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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 despite standard medical management
  • Has symptomatic congestive heart failure, symptomatic or poorly controlled cardiac arrhythmia, or any other serious, uncontrolled medical disorders, which in the opinion of the investigator would make the participant ineligible for participation in the study
  • Has known brain or leptomeningeal metastases
  • Has known positive status for human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome-related illness
  • Has known active drug or alcohol abuse
  • 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 the primary cancer is non-small-cell lung cancer (NSCLC), there is radiographic evidence of intratumor cavitation, major blood vessel invasion or encasement by cancer, or proximity of cancer to major airways
  • Has received prior ramucirumab (IMC-1121B) therapy
  • Is receiving concomitant therapy with clinically relevant inhibitors or inducers of cytochrome P450 3A4 and 3A5 and/or isoenzymes
  • Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis and a history of hepatic encephalopathy, or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • ImClone Investigational Site

    Ann Arbor, Michigan, 48109

  • ImClone Investigational Site

    Cleveland, Ohio, 44195

  • ImClone Investigational Site

    Detroit, Michigan, 48202

  • ImClone Investigational Site

    Huntersville, North Carolina, 28078

  • ImClone Investigational Site

    New Brunswick, New Jersey, 08901

  • ImClone Investigational Site

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Study to Evaluate the Potential of Concomitant Ramucirumab to Affect the Pharmacokinetics of Docetaxel in Patients With Advanced Malignant Solid Tumors

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.

Being tested
Ramucirumab, Docetaxel
Keywords
Advanced Malignant Solid Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RamucirumabBiological

    Also called IMC-1121B, LY3009806

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

  • DocetaxelDrug

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

Study groups in NCT01567163
Study groupRoleWhat they receive
ramucirumab (IMC-1121B) and docetaxelExperimentalCycle 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
Receives: Biological: Ramucirumab; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

  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

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

  3. Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 1

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

  4. Pharmacokinetics: Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Docetaxel in Cycle 2

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

Secondary outcomes (3)

  1. 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).

    Measured: Cycle 1, Day 1 through Cycle 2, Day 1 and 30 days after last dose of study drug

  2. Pharmacokinetics: Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Docetaxel

    Measured: 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

  3. Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Docetaxel

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionDec 2012
  4. Study completionMar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01567163
Sponsor's protocol ID
14434
Other IDs
CP12-0713, I4T-IE-JVCC
Status last verified
Oct 2014
First submitted
28 Mar 2012
Last updated
16 Oct 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ramucirumab and Docetaxel in people with Malignant Solid Tumor, run by Eli Lilly and Company at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01567163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2014.

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