Phase I Trial of Tanibirumab in Advanced or Metastatic Cancer

NCT01660360 | Completed Phase 1

• 1 other identifier: PMC1101-TAAC01
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

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

Conditions

Advanced Cancer; Metastatic Cancer

Keywords

Tanibirumab Phase I trial

Outcome Measures

Primary Outcomes (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.

  28days

Secondary Outcomes (2)

• Pharmacokinetics

  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.

• Efficacy

  completion of 2 and more cycle

Study Arms (1)

Tanibirumab

EXPERIMENTAL

The 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.

Biological: Tanibirumab

Interventions

Tanibirumab BIOLOGICAL

Tanibirumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• PharmAbcine: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-230, South Korea

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

olinvacimab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Young Seok Park, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 8, 2012
• Study Start: November 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

KR (1)