A Dose-escalation Study of BIBF 1120 in Japanese Patients With Advanced Solid Tumours

NCT02182128 | Completed Phase 1

• 1 other identifier: 1199.19
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Confirmation of BIBF 1120 administered from 150 mg twice daily (b.i.d.) to 250 mg b.i.d. as safe and tolerable treatment in Japanese patients with advanced solid tumours, overall safety, pharmacokinetic parameters, biomarkers, and efficacy of BIBF 1120.

Conditions

Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose Limiting Toxicities (DLT) associated with increasing doses of BIBF 1120

  Up to 36 months

• Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTCAE Version 3.0) associated with increasing doses of BIBF 1120

  up to 36 months

Secondary Outcomes (28)

• maximum tolerated dose (MTD) of BIBF 1120

  Up to 36 months

• Objective tumour response according to the response evaluation criteria in solid tumours (RECIST)

  Up to 36 months

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 12 hours after single dose administration (AUC0-12)

  before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours after the first drug administration

• Change from baseline in peripheral blood biomarkers

  Baseline, day 2, day 8, day 30

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24hours after single dose administration (AUC0-24)

  before and 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours after the first drug administration

Study Arms (1)

BIBF 1120

EXPERIMENTAL

Drug: BIBF 1120

Interventions

BIBF 1120 DRUG

BIBF 1120

Eligibility Criteria

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

You may qualify if:

• Male or female patients with a confirmed diagnosis of an advanced, non resectable and/or metastatic solid tumour (except for malignant lymphoma)
• Patients who have not responded to conventional treatment, or for whom no therapy of proven efficacy was available, or who were not amenable to established forms of treatment
• Patients recovered from any therapy-related toxicities from previous chemo-, hormone-, immuno-, or radio-therapies (except for epilation) at least over the following periods of time:
• four weeks after chemotherapy (at least 2 weeks after receiving antimetabolite or at least 6 weeks after nitrosourea or mitomycin C)
• two weeks after receiving hormone therapy
• four weeks after receiving radiation therapy (2 weeks after radiation for symptom control)
• two weeks after receiving immunotherapy
• four weeks after surgical procedures
• Age 20 years or older
• Life expectancy of at least 3 months
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2
• Patients retaining a significant physiological compensatory function and without manifest marked disorders of the hematopoietic system, heart, lung, liver, kidneys, etc., i.e., patients with sufficient baseline organ function
• An absolute neutrophil count more than 1500/mm3
• A platelet count more than 100000/mm3
• A haemoglobin count more than 9.0 g/dL

You may not qualify if:

• Brain tumour, and/or brain metastases requiring therapy
• History of obvious pulmonary fibrosis or interstitial pneumonitis in chest X-ray including pneumoconiosis or radiation-induced pulmonary fibrosis expanding out of radiation field
• Patients with difficulty in swallowing study medication
• Gastrointestinal disorders that might interfere with the absorption of the study drug (Crohn's disease, ulcerative colitis, broad resection of the stomach)
• Patients with diarrhoea greater than CTCAE grade 2
• Patients within 4 weeks after major surgical procedures or patients with active ulcers or with injuries with incomplete wound healing
• History of autoimmune disease
• History of serious drug hypersensitivity
• History of cardiac infarction or congested heart failure of New York Heart Association Classification (NYHA) II or greater within previous 6 months
• Serious illness or concomitant non-oncological disease difficult to be controled by medication, such as active infectious disease, hepatic failure, renal failure, pulmonary fibrosis, interstitial pneumonitis, hemorrhagic tendency, heart disease (congested heart failure, angina, arrhythmia, etc.), uncontrolled, severe hypertension, and diabetes
• Pregnancy or breastfeeding
• Women and men who are sexually active and unwilling to use a medically acceptable method of contraception until 4 weeks after the last trial visit
• Patients positive in tests of hepatitis B (HBs) antigen, hepatitis C (HCV)antibody, or HIV antibody
• Alcohol or drug abuse
• Patient not suitable for participation in this clinical trial in the opinion of the investigator

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Neoplasms

Interventions

nintedanib

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: July 2, 2014
• First Posted: July 8, 2014
• Study Start: June 1, 2006
• Primary Completion: June 1, 2009
• Last Updated: July 18, 2014

Record last verified: 2014-07