BIBF 1120 + Docetaxel (Japan) in Patients With Advanced Non-small-cell Lung Cancer, Phase I

NCT00876460 | Completed Phase 1 Results

• 1 other identifier: 1199.29
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 2

Brief Summary

To confirm the safety of BIBF 1120 at a dose level up to 200 mg x 2/day (i.e., overseas recommended Phase III dose for combination treatment) with standard therapy of docetaxel (60 mg/m2 and 75 mg/m2) in Japanese advanced non small cell lung cancer (NSCLC) patients with stage IIIB/IV or recurrent after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experienced Dose Limited Toxicity in Combination Therapy of Nintedanib and Docetaxel

  Number of participants experienced Dose Limited Toxicity (DLT) in combination therapy of nintedanib and docetaxel. Maximum tolerated dose (MTD) of nintedanib combination with docetaxel were to be determined separately in the patient groups of body surface area (BSA) \<1.5 m2 and BSA ≥1.5 m2. The MTD were to be determined as a combination of a dose equal to or less than 200 mg b.i.d. of nintedanib and 60 mg/m2 and 75 mg/m2 every 3 weeks of docetaxel at which either 0 out of 3, 1 out of 6, or 2 out of 6 patients experienced DLT.

  During the first treatment course, up to 3 weeks

• Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses

  Number of participants with adverse events according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses. The CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).

  Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days

Secondary Outcomes (11)

• Objective Tumor Response

  Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)

• Disease Control

  Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)

• Progression-Free Survival (PFS)

  Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)

• Time to Treatment Failure (TTF)

  Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)

• Clinical Relevant Abnormalities in Laboratory Parameters

  Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days

Study Arms (1)

BIBF 1120 + docetaxel

EXPERIMENTAL

Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks

Drug: BIBF 1120 M + docetaxel M; Drug: BIBF 1120 M + docetaxel H; Drug: BIBF 1120 H + docetaxel H; Drug: BIBF 1120 L + docetaxel M; Drug: BIBF 1120 H + docetaxel M

Interventions

BIBF 1120 M + docetaxel M DRUG

BIBF 1120 Medium dose bid + docetaxel 60 mg/m2

BIBF 1120 + docetaxel

BIBF 1120 M + docetaxel H DRUG

BIBF 1120 Medium dose bid + docetaxel 75mg/m2

BIBF 1120 + docetaxel

BIBF 1120 H + docetaxel H DRUG

BIBF 1120 HIgh dose bid + docetaxel 75 mg/m2

BIBF 1120 + docetaxel

BIBF 1120 L + docetaxel M DRUG

BIBF 1120 Low dose bid + docetaxel 60 mg/m2

BIBF 1120 + docetaxel

BIBF 1120 H + docetaxel M DRUG

BIBF 1120 HIgh dose bid + docetaxel 60 mg/m2

BIBF 1120 + docetaxel

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically/cytologically confirmed, locally advanced/metastatic NSCLC of stage IIIB/IV or recurrent NSCLC (all histologies. Existence or nonexistence of measurable lesion according to RECIST is no object.)
• Patients with one prior chemotherapy regimen including platinum-containing drug.
• In case of recurrent disease, one additional prior regimen is allowed for adjuvant and/or neoadjuvant therapy. However monotherapy of EGFR-TKI (i.e. erlotinib/Tarceva® and gefitinib/Iressa®) is not counted as 'one regimen'.
• Male or female patients age \>=20 years and =\<74 years at the enrolment.
• Life expectancy of at least three (3) months after the start of administration of the investigational drug.
• Eastern Cooperative Oncology Group (ECOG) \[R01-0787\] performance Score 0 or 1.
• Patients retaining a significant physiological compensatory function and patients with sufficient baseline organ function as follows:
• Haemoglobin count more than 9.0g/dL
• Absolute neutrophil count more than 1500/mm3
• Platelet count more than 100 000/mm3
• Serum creatinine less than or equal to1.5x upper limit of normal range at the investigator site
• Aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT) less than or equal to 1.5x upper limit of normal range at the investigator site (It is the same if patients have liver metastases)
• PaO2 or SpO2 more than 60torr or 92%
• Written informed consent that is consistent with ICH-GCP guidelines.

You may not qualify if:

• Patients who have received chemotherapy (including other investigational drug), hormonal therapy and immune therapy =\<4 weeks prior to registration or who have not recovered from side effects of such therapy.
• Patients who have received radiotherapy =\<4 weeks (limited field (e.g brain or bone metastasis) radiation =\<2 weeks) prior to registration.
• Patients who have active brain metastases. (Patients who have no symptoms and is not needed to receive therapy in the registration may participate in this trial)
• Patients with active double cancer. (Patients who have skin cancer that is not malignant melanoma and carcinoma in situ of uterine cervix may participate in this trial)
• Patients with distinct / suspected pulmonary fibrosis or interstitial lung disease by the chest radiographic findings, or patients with a previous history of.
• History of clinically significant haemoptysis within the past 3 months (more than one tea spoon of fresh blood per day)
• Therapeutic anticoagulation (except low dose heparin and/or heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except for chronic low-dose therapy with acetylsalicylic acid =\<325 mg per day)
• History of major thrombotic or clinically relevant major bleeding event in the past 6 months prior to registration.
• Known inherited predisposition to bleeding or thrombosis.
• Significant cardiovascular diseases. (i.e. hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 6 months, congestive heart failure \> NYHA II, serious cardiac arrhythmia, pericardial effusion)
• Significant weight loss (\> 10 %) within the past 6 weeks prior to registration in the this trial
• Current peripheral neuropathy \>= CTCAE grade 2 except due to trauma.
• Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment
• Major injuries and/or surgery within the past 10 days prior to registration with incomplete wound healing.
• Serious infections requiring systemic antibiotic (e.g antiviral, antimicrobial, antifungal) therapy.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

1199.29.002 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

Location

1199.29.001 Boehringer Ingelheim Investigational Site

Osaka-Sayamashi, Osaka, Japan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: April 6, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: July 1, 2015
• Last Updated: November 17, 2016
• Results First Posted: December 4, 2014

Record last verified: 2016-09

Locations

JP (2)