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Breast CancerPhase 1NCT01256567

A Study of Ramucirumab (IMC-1121B) in Participants With Breast Cancer

A Phase 1 study testing Ramucirumab and Docetaxel in people with Breast Cancer and Metastatic Breast Cancer, run by Eli Lilly and Company at 4 sites in Japan.

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 primary objective of this study is to investigate the safety and tolerability of the anti-VEGFR-2 monoclonal antibody ramucirumab drug product in combination with docetaxel in Japanese participants with metastatic, or locally advanced breast cancer, with the aim of confirming the recommended dose of ramucirumab… Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Breast Cancer, Metastatic Breast Cancer
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
7 participants
Where
4 sitesJapan
Study dates
Dec 2010to Feb 2013
Phase
Phase 1
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 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant is Japanese
  • The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • The participant has a histopathologically or cytologically confirmed diagnosis of breast adenocarcinoma that is now metastatic or locally-recurrent and inoperable with curative intent
  • The participant has measurable and/or non-measurable disease
  • The participants' primary and/or metastatic tumor is Human Epidermal Growth Factor Receptor 2 (HER2) negative
  • The participant received neo adjuvant or adjuvant taxane therapy ≥ 6 months prior to the study
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  • The participant received neo adjuvant or adjuvant biologic therapy ≥ 6 weeks prior to the study
  • The participant completed all prior radiotherapy ≥ 3 weeks prior to the study registration date
  • The participant received prior hormonal therapy for breast cancer in the neo adjuvant, adjuvant,and/or the metastatic setting ≥ 2 weeks prior to the study registration date
  • The participant's left ventricular ejection fraction (LVEF) is within normal ranges
  • The participant has adequate hematologic, hepatic, and coagulation function.
  • Eligible participants of reproductive potential agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for 12 weeks after the last dose of study medication

Who cannot join

  • The participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non-melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. Participants with previous treatment of malignancy is eligible, provided that she has been disease free for >3 years
  • The participant has a known sensitivity to docetaxel
  • The participant has a known sensitivity to agents of similar biologic composition as ramucirumab
  • The participant has a history of chronic diarrheal disease within 6 months prior to the study registration date
  • The participant has received irradiation to a major bone marrow area within 30 days prior to the study registration date
  • The participant has received any experimental agents within 4 weeks prior to the study registration date
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  • The participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
  • The participant has Grade 3-4 bleeding within 3 months prior to the study registration date
  • The participant has an ongoing or active infection requiring antibiotic, antifungal, or antiviral therapy
  • The participant has uncontrolled hypertension, symptomatic congestive heart failure, psychiatric illness, or any other serious uncontrolled medical disorders
  • The participant has brain metastases
  • The participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness
  • The participant is pregnant or lactating
  • The participant has not fully recovered from effects of prior chemotherapy
  • The participant has undergone major surgery within 28 days prior to the study registration date

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

  • ImClone Investigational Site

    Hidaka, 350-1298

  • ImClone Investigational Site

    Matsuyama, 790-0007

  • Imclone Investigational Site

    Nagoya, 464-8681

  • ImClone Investigational Site

    Osaka, 540-0006

Other trials in Japan

About this study

Official title: A Phase 1b Study of Docetaxel in Combination With Ramucirumab (IMC-1121B) Drug Product in Patients With Locally Advanced or Metastatic Breast Cancer

The primary objective of this study is to investigate the safety and tolerability of the anti-VEGFR-2 monoclonal antibody ramucirumab drug product in combination with docetaxel in Japanese participants with metastatic, or locally advanced breast cancer, with the aim of confirming the recommended dose of ramucirumab drug product (DP) in combination with docetaxel.

Being tested
Ramucirumab, Docetaxel
Medical subject headings
Breast Neoplasms

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 administered as an intravenous (I.V.) infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks.

  • DocetaxelDrug

    Docetaxel administered by intravenous (I.V.) infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.

Study groups in NCT01256567
Study groupRoleWhat they receive
ramucirumab and docetaxel combinationExperimentalNot described
Receives: Biological: Ramucirumab; Drug: Docetaxel

What is being measured

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

  1. Number of Participants With Adverse Events

    Number participants with drug related dose-limiting toxicities (DLT) during Cycle 1; ramucirumab related: treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or higher TEAE, or TEAE leading to discontinuation or ramucirumab dose modification. DLT=G4 neutropenia >7days; G ≥3 neutropenia with fever ≥38.5°C requiring IV antibiotics or bacteriemia or sepsis; G4 thrombocytopenia; G ≥3 thrombocytopenia with bleeding requiring platelets; G≥3 prothrombin time and/or partial thromboplastin time in absence of anticoagulants; G≥2 hyperbilirubinemia ≥5 days; QTc >500 milliseconds (ms) or increase ≥100 ms or arrhythmia; G≥4 or uncontrollable hypertension; G≥3 nonhematologic toxicity (excluding G3: hypersensitivity, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea without loperamide therapy, nausea/vomiting without antiemetics, transient G3/4 elevation of aminotransferases); treatment delay >2 weeks due to toxicity.

    Measured: Baseline up to data cut off (approximately 48.3 weeks)

Secondary outcomes (6)

  1. Serum Anti-IMC-1121B Antibody Assessment (Immunogenicity)

    The number of participants with a positive anti-IMC-1121B titer at any point during the study.

    Measured: Baseline up to data cut off (approximately 48.3 weeks)

  2. Maximum Concentration (Cmax) of Ramucirumab

    Cmax (Cycle 1) and Cmax at steady state (Cmax,ss, Cycle 4) of ramucirumab are provided.

    Measured: Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)

  3. Area Under the Curve (AUC) of Ramucirumab

    AUC from time zero to infinity (AUC[0-inf], Cycle 1) and at steady state (AUC tau, Cycle 4) of ramucirumab are provided.

    Measured: Day 1 of Cycles 1 and 4 (cycle=21 days)

  4. Half Life (t 1/2) of Ramucirumab

    Measured: Day 1 of Cycles 1 and 4 (cycle=21 days)

  5. Clearance (Cl) of Ramucirumab

    Clearance (Cycle 1) and at steady state (Clss, Cycle 4) of ramucirumab are provided.

    Measured: Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)

  6. Steady State Volume of Distribution (Vss) of Ramucirumab

    Measured: Day 1 of Cycle 1 and 4 (cycle=21 days)

Timeline

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

  1. First posted8 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionNov 2012
  4. Study completionFeb 2013

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01256567
Sponsor's protocol ID
14200
Other IDs
CP12-1028, I4T-IE-JVBX
Status last verified
May 2014
First submitted
7 Dec 2010
Last updated
18 Jun 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ramucirumab and Docetaxel in people with Breast Cancer and Metastatic Breast Cancer, run by Eli Lilly and Company at 4 sites in Japan.

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 12 inclusion and 15 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 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Number of Participants With Adverse Events (time frame: Baseline up to data cut off (approximately 48.3 weeks)). 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 NCT01256567.

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 18 Jun 2014.

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