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Advanced CancerPhase 1NCT01660360

Phase I Trial of Tanibirumab in Advanced or Metastatic Cancer

A Phase 1 study testing Tanibirumab in people with Advanced Cancer and Metastatic Cancer, run by PharmAbcine at 1 site in South Korea.

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 assess the safety, tolerability, and maximum tolerated dose (MTD) of Tanibirumab in patients with advanced or metastatic cancer who are refractory or for whom there are no standard therapeutic option. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Advanced Cancer, Metastatic Cancer
What is being tested?
Tanibirumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteSouth Korea
Study dates
Nov 2011to Sep 2013
Phase
Phase 1
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 20 years
  • Signed informed consent
  • Histologically documented, incurable, locally advanced or metastatic cancers that have failed to respond to at least one prior regimen or for which there is no standard therapy.
  • Disease that is measurable or evaluable by RECIST 1.1 criteria (for Solid Tumors)
  • ECOG performance status 0-2
  • Documented negative pregnancy test for women of childbearing potential and use of an effective means of contraception for both men and women while enrolled in the study
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  • Granulocyte count ≥ 1,500/㎣, platelet count ≥ 100,000/㎣, and hemoglobin ≥ 9 g/dL
  • Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)(≤ 3 x ULN if liver metastatic cancer)
  • Alkline phosphatase, AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN if liver metastatic cancer)
  • Serum creatinine ≤ 1.5 mg/dL
  • INR (international normalized ratio) ≤ 1.3, and aPTT (activated partial thromboplastin time) ≤ 1.5 x ULN
  • Subject had to have a projected life expectancy of at least 3 months
  • Bazetts correction QTc < 450 msec in ECG at Screening

Who cannot join

  • Less than 4 weeks since last chemotherapy (including biologic unless previous Avastin treatment, experimental, and hormonal therapy), radiation therapy, or major surgical procedure
  • All incisions from any procedure must be fully healed and sutures removed prior to infusion on Day 1
  • Pleural effusions, ascites, or leptomeningeal disease as the only manifestation of the current malignancy
  • Subjects that have hypertension that is remained uncontrolled, despite drug regimen.
  • Subjects with grade III or IV hemorrhage/bleeding and who have experienced pulmonary hemorrhage/hemoptysis (exceed size of 2.5 mL of erythrocyte) or who have experienced grade III/IV hemorrhage/bleeding.
  • The presence of gastrointestinal perforation
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  • The presence of tracheoesophageal fistula or grade Ⅳ fistula
  • Subjects with grade Ⅳ proteinuria (nephritic syndrome)
  • The presence of arterial thromboembolic events
  • Subjects who have history of life threatening (grade Ⅳ) pulmonary embolism
  • Subjects with a known hypersensitivity to CHO cell product or other recombined human or humanized antibody
  • Subjects with mental illness
  • Subjects with a known hypersensitivity to any of the ingredients/substrates in investigational product of this study
  • Subjects who given any investigational drug within longer period between 30 days and 5 times of half life before participation in this study
  • Active infection requiring IV antibiotics
  • Active autoimmune disease that is not controlled by drugs
  • Clinically important history of liver disease, including viral or other active hepatitis, current alcohol abuse, or cirrhosis
  • Known human immunodeficiency virus (HIV) infection
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the subjects at high risk from treatment complications
  • Significant traumatic injury within 3 weeks of Day 1
  • Inability to comply with study and follow-up procedures

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul, 135-230

Other trials in South Korea

About this study

Official title: A Phase I Study of the Safety and Pharmacokinetics of a Fully Human Monoclonal Antibody to the Vascular Endothelial Growth Factor Receptor2 (Tanibirumab) in Patients With Advanced Cancers or Metastatic Cancer

The primary objective of this study is to assess the safety, tolerability, and maximum tolerated dose (MTD) of Tanibirumab in patients with advanced or metastatic cancer who are refractory or for whom there are no standard therapeutic option.

  • To evaluate the pharmacokinetics of Tanibirumab in such patients
  • To determine a recommended phase II dose (RP2D) of Tanibirumab based on above assessments
Read the detailed description

This is a Phase I, first-in-human, open-label, non-randomized, dose-escalating study of Tanibirumab which is a fully human monoclonal antibody to vascular endothelial growth factor receptor 2 (VEGFR2/KDR). This study will enroll patients with advanced or metastatic cancer who are refractory or for whom there are no standard therapeutic options. Tanibirumab will be administered intravenously to such patients over 60 minutes on Day 1, 8, and 15 (subject to change pending PK and toxicity data). Each treatment cycle will be a minimum of 28 days in length. The dose escalation study employing a 3 + 3 design is designed to identify the RP2D which will be based on safety, tolerability and PK of the RP2D. This study is expected to enroll a total of approximately 18-24 patients.

Being tested
Tanibirumab
Keywords
Tanibirumab Phase I trial
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • TanibirumabBiological

Study groups in NCT01660360
Study groupRoleWhat they receive
TanibirumabExperimentalThe total dose of Tanibirumab for each patient will depend on dose level assignment and the patient's weight. Dose levels to be potentially tested in Phase I include: 1 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, 12 mg/kg, 16 mg/kg, and 20 mg/kg.
Receives: Biological: Tanibirumab

What is being measured

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

  1. Safety and tolerability

    The safety and tolerability of Tanibirumab will be assessed using the following measures: frequency and nature of dose-limiting toxicities (DLTs); nature, severity, and relatedness of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v4.0; changes in vital signs; and changes in clinical laboratory parameters.

    Measured: 28days

Secondary outcomes (2)

  1. Pharmacokinetics

    The following PK parameters will be derived from the serum concentration-time profile of Tanibirumab following administration: serum total exposure (AUC), Cmax, clearance, volume of distribution (central compartment Vc and at steady state Vss), and half-life (t½).

    Measured: Cycle 1 : predose, 0.5, 2, 4, 24 and 72 hours after 1st dose, predose and 0.5 hours after 2nd dose, predose, 0.5, 2, 4, 24, 72, 168 and 336 hours after 3rd dose. After cycle 2: predose of 1st dose and 0.5 hour after 3rd dose.

  2. Efficacy

    The following activity outcome measures will be assessed: objective response, defined as a complete or partial response confirmed 4 weeks after initial documentation; duration of objective response; and progression-free survival. Objective response and disease progression will be determined using RECIST 1.1

    Measured: completion of 2 and more cycle

Timeline

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

  1. First posted8 Aug 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionSep 2013
  4. Study completionSep 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
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01660360
Sponsor's protocol ID
PMC1101-TAAC01
Status last verified
Jan 2014
First submitted
6 Aug 2012
Last updated
29 Jan 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tanibirumab in people with Advanced Cancer and Metastatic Cancer, run by PharmAbcine at 1 site in South Korea.

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 13 inclusion and 21 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 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and tolerability (time frame: 28days). 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 NCT01660360.

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 29 Jan 2014.

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