BIBF 1120 in Combination With Pemetrexed in Advanced Non Small Cell Lung Cancer (NSCLC)

Phase 1

Terminated

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: BIBF 1120 M + Pemetrexed; Drug: BIBF 1120 RD + Pemetrexed; Drug: BIBF 1120 Placebo + Pemetrexed; Drug: BIBF 1120 H + Pemetrexed; Drug: BIBF 1120 L + Pemetrexed

• Registration Number: NCT00979576
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objectives of this trial are to estimate the following in Japanese patients with advanced NSCLC of stage IIIB/IV or with recurrence after failure of first-line chemotherapy.

Phase I part The objective of the phase I part is to define the Maximum Tolerated Dose (MTD) of BIBF 1120 at a dose level up to twice daily 200 mg with standard dose of pemetrexed (500 mg/m\^2) and to determine the Recommended Dose (RD) for the phase II part.

Phase II, to investigate the efficacy and safety of BIBF 1120 in combination with pemetrexed (500 mg/m\^2) as compared to pemetrexed (500 mg/m\^2) + placebo

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 First Submitted: 2009-09-17
• Study First Submitted QC: 2009-09-17
• Study First Posted: 2009-09-18
• Study Start: 2009-10
• Primary Completion: 2012-05
• Results First Submitted: 2014-11-14
• Results First Submitted QC: 2014-11-14
• Results First Posted: 2014-11-20
• Study Completion: 2015-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-11
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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 BID + Pemetrexed	BIBF 1120 M + Pemetrexed	Phase I part: Find MTD by using low, medium or high BIBF 1120 twice daily and 500mg/m\^2 pemetrexed once every 3 weeks
BIBF 1120 BID + Pemetrexed	BIBF 1120 H + Pemetrexed	Phase I part: Find MTD by using low, medium or high BIBF 1120 twice daily and 500mg/m\^2 pemetrexed once every 3 weeks
BIBF 1120 BID + Pemetrexed	BIBF 1120 L + Pemetrexed	Phase I part: Find MTD by using low, medium or high BIBF 1120 twice daily and 500mg/m\^2 pemetrexed once every 3 weeks
BIBF 1120 BID (RD) + Pemetrexed	BIBF 1120 RD + Pemetrexed	PHase II part: Study arm
BIBF 1120 BID(Placebo) + Pemetrexed	BIBF 1120 Placebo + Pemetrexed	Phase II part: Comparator arm

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities	During the first course, 21 days	Number of participants with dose limiting toxicity (DLT) in combination therapy of BIBF 1120 and pemetrexed during the first course
Adverse Events According to Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 for All Courses	Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days	Number of patients with adverse events according to worst Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 for all courses.; CTCAE grades are: 1 (mild AE), 2 (moderate AE), 3 (severe AE), 4 (life-threatening or disabling AE) or 5 (death related to AE).

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	Every 6 weeks after start of study treatment until end of treatment, up to 992 days	Number of participants with complete response (CR) or partial response (PR) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0
Disease Control Rate	Every 6 weeks after start of study treatment until end of treatment, up to 992 days	Number of participants with complete response (CR), partial response (PR) or stable disease (SD) according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.0
Duration of Disease Control	From first study drug administration until PD or death, up to 1003 days	Duration of disease control was defined as the time period from the first study drug administration to the progressive disease (PD) or death of patients, whichever occurred earlier.
Number of Participants With Clinically Relevant Abnormalities in Laboratory Parameters	Between first administration of pemetrexed and 28 days after last administration of pemetrexed and/or BIBF 1120, up to 1020 days	Number of participants with clinically relevant abnormalities in laboratory parameters reported as adverse events which occurred in \>= 20% of patients
AUC0-inf of Nintedanib	5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1	Area under the concentration-time curve of nintedanib in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Cmax of Nintedanib	5 minutes (min) before nintedanib administration and 1h, 2h, 3h, 4h, 6h, 7h, 10h and 23h 55min after nintedanib administration in cycle 1	Maximum measured concentration of nintedanib in plasma (Cmax)
AUC0-inf of Pemetrexed	5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2	Area under the concentration-time curve of pemetrexed in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Cmax of Pemetrexed	5 minutes (min) before pemetrexed administration and 10min, 40min, 1 hour (h), 2h, 4h, 6h, 23h 55min, 47h 55min after pemetrexed administration in cycles 1 and 2	Maximum measured concentration of pemetrexed in plasma (Cmax)

Trial Locations

Locations (3)

1199.28.003 Boehringer Ingelheim Investigational Site; 🇯🇵 Chiba,Kashiwa, Japan

1199.28.002 Boehringer Ingelheim Investigational Site; 🇯🇵 Miyakojima-ku, Osaka, Japan

1199.28.001 Boehringer Ingelheim Investigational Site; 🇯🇵 Osaka-Sayama, Osaka, Japan