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

Phase 1

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: 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

• Registration Number: NCT00876460
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-03
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Primary Completion: 2012-09
• Results First Submitted: 2014-11-14
• Results First Submitted QC: 2014-11-28
• Results First Posted: 2014-12-04
• Study Completion: 2015-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIBF 1120 + docetaxel	BIBF 1120 H + docetaxel M	Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks
BIBF 1120 + docetaxel	BIBF 1120 M + docetaxel H	Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks
BIBF 1120 + docetaxel	BIBF 1120 L + docetaxel M	Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks
BIBF 1120 + docetaxel	BIBF 1120 H + docetaxel H	Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks
BIBF 1120 + docetaxel	BIBF 1120 M + docetaxel M	Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks

Primary Outcome Measures

Name	Time	Method
Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses	Between the first administration of docetaxel and 28 days after last administration of docetaxel and/or nintedanib, up to 1367 days	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).
Number of Participants Who Experienced Dose Limited Toxicity in Combination Therapy of Nintedanib and Docetaxel	During the first treatment course, up to 3 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)	For participants with known date of progression or death (of any cause): PFS \[days\] = earlier of date of progression or death - date the study treatment started + 1.; For participants known to be alive without progression by the end of trial or follow-up visit: PFS (censored) \[days\] = date of last imaging when the participant is known to be progression-free and alive - date the study treatment started + 1.; Progression is assessed according to RECIST version 1.0.
AUC0-inf of Nintedanib in Course 1	-0:05 hours (h) before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1	AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of nintedanib in course 1
Objective Tumor Response	Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)	Number of participants with objective response defined as complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0
Disease Control	Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)	Number of participants with disease control, defined as complete response (CR) or partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0
Time to Treatment Failure (TTF)	Pre-treatment, every 6 weeks from treatment course 3, end of treatment (up to 1367 days)	For participants with known date of discontinuation of the study treatment (or progression \[not necessarily confirmed by tumour imaging; can also be based on any clinical sign of tumour progression\] or death): TTF \[days\] = earlier of date of discontinuation of the study treatment, progression, or death - date the study treatment started + 1.; For participants known to be alive without progression by the end of trial or follow-up visit: TTF (censored) \[days\] = date when the patient is known to be progression-free and alive - date the study treatment started + 1.; Progression is assessed according to RECIST version 1.0.
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	Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events
Cmax of Docetaxel in Course 1	-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration	Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 1
AUC0-inf of Docetaxel in Course 2	-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration	AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 2.; Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol.
Cmax of Nintedanib in Course 1	-0:05h before drug administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23:55h after drug administration in course 1	Cmax (maximum measured plasma concentration) after the first administration of nintedanib in course 1
AUC0-inf of Docetaxel in Course 1	-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration	AUC0-inf (area under the plasma concentration-time curve over the time interval from 0 extrapolated to infinity) after the first administration of docetaxel in course 1
Cmax of Docetaxel in Course 2	-0:05h before drug administration and 1h, 1.5h, 2h, 3h, 4h, 7h, 23:55h and 47:55h after drug administration	Cmax (maximum measured plasma concentration) after the first administration of docetaxel in course 2.; Docetaxel 50 mg/m2 patients were assigned to Docetaxel 60 mg/m2 in Cycle 1, but the dose was reduced to 50 mg/m2 in Cycle 2 as defined in the Clinical Trial Protocol.

Trial Locations

Locations (2)

1199.29.002 Boehringer Ingelheim Investigational Site; 🇯🇵 Fukuoka, Fukuoka, Japan

1199.29.001 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka-Sayamashi, Osaka, Japan