Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Nintedanib

Tubulin Modulators

Antimitotic Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

patients to receive backbone chemotherapy and nintedanib

Boehringer Ingelheim

To determine the appropriateness of the dose of nintedanib 200 mg b.i.d. plus docetaxel 75 mg/m2 as starting dose by evaluating the safety in Japanese patients with body surface area (BSA) \<1.5 m2 and locally advanced or metastatic adenocarcinoma subtype non-small cell lung cancer (NSCLC) after failure of first line platinum- based chemotherapy

Nintedanib Plus Docetaxel in Japanese Patients With Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy

An Open Label Phase I Safety run-in Trial of Oral Nintedanib Plus Docetaxel Therapy in Japanese Patients With Locally Advanced or Metastatic Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of Platinum-based First Line Chemotherapy

DLT was defined as any of the following study drug related adverse events (AEs):

* Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 non-haematological toxicity except transient electrolyte abnormality and isolated increase of gamma-glutamyltransferase (GGT); gastrointestinal toxicity, despite adequate supportive care
* CTCAE grade 4 haematological toxicity; Neutrophil count decreased or white blood cell count (not associated with fever) for \>7 days despite adequate supportive treatment
* CTCAE grade 4 febrile neutropenia with fever ≥38.5 degrees
* CTCAE grade ≥2 alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) increase in conjunction with CTCAE grade ≥2 total bilirubin increase
* Inability to resume nintedanib dosing within 14 days after stopping Investigators judged clinically as DLT after dose reduction and severity medically notable (CTCAE, version 3). Sponsor with safety review committee was allowed to confirm the adequacy of this judgment.

This outcome measure presents the maximum measured concentration (Cmax) of nintedanib in plasma in cycle 1.

This outcome measure presents the Cmax of docetaxel in plasma in cycles 1 and 2.

This outcome measure presents the area under the concentration-time curve of nintedanib over the time interval from 0 to time of the last quantifiable concentration in plasma (AUC0-tz) in cycle 1.

This outcome measure presents AUC0-tz of docetaxel in plasma in cycles 1 and 2.

This outcome measure presents the Area under the concentration-time curve of nintedanib over the time interval from 0 extrapolated to infinity in plasma (AUC0-infinity) in cycle 1.

This outcome measure presents the AUC0-infinity of docetaxel in plasma in cycles 1 and 2.

The patient received 200 mg of nintedanib b.i.d. (orally) and once every 21 days 75 mg/m² of docetaxel was administered intravenous.

Nintedanib Plus Docetaxel

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Treated set included all patients who were dispensed study medication and were documented to have taken at least one dose of study treatment (docetaxel or nintedanib).

Boehringer Ingelheim, Call Center

Total with DLTs - all grades

Total with DLTs - grade 1/2

Total with DLTs - grade 3/4/5

Hepatobiliary disorders (hep. dis.) - all grades

Hep. dis. - grade 1/2

Hep. dis. - grade 3/4/5

Hep. dis. - hyperbilirubinaemia - all grades

Hep. dis. - hyperbilirubinaemia - grade 1/2

Hep. dis. - hyperbilirubinaemia - grades 3/4/5

Investigations (inv.) - all grades

Inv. - grade 1/2

Inv. - grade 3/4/5

Inv. - ALT increased - all grades

Inv. - ALT increased - grades 1/2

Inv. - ALT increased - grades 3/4/5

Inv. - AST increased - all grades

Inv. - AST increased - grades 1/2

Inv. - AST increased - grades 3/4/5

Treated set 2 included all patients who were dispensed study medication and were documented to have taken at least one dose of study treatment, except replaced patients according to the trial clinical protocol.

Number of Patients Experiencing Dose Limiting Toxicity (DLT) in Cycle 1

Pharmacokinetic set (PKS) included all patients in treated set who had at least one valid drug plasma concentration available. This patient set was used for the analysis of pharmacokinetics.

Maximum Measured Concentration (Cmax) of Nintedanib

Cycle 1

Cycle 2

Cmax of Docetaxel

Area Under the Concentration-time Curve of Nintedanib Over the Time Interval From 0 to Time of the Last Quantifiable Concentration (AUC0-tz)

AUC0-tz of Docetaxel

Area Under the Concentration-time Curve of Nintedanib Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity)

AUC0-infinity of Docetaxel

The patient received 2\*100 milligram (mg) twice daily (b.i.d.) of nintedanib. Nintedanib was administered orally in a soft gelatine capsule. It was allowed to reduce the daily dose to 150 mg b.i.d. or 100 mg b.i.d. No dose increase was allowed after a dose reduction.

Once every 21 days 75 milligram (mg)/ square meters (m²) of docetaxel was administered intravenous (over one hour). It was also allowed to reduce the dose of this intravenous infusion to 60 mg/m² or 50 mg/m². Thereafter it was not allowed to increase the dose again.

Nintedanib Plus Docetaxel (Patient Disposition for Nintedanib)

The patient received 2\*100 milligram (mg) b.i.d. of nintedanib. Nintedanib was administered orally in a soft gelatine capsule. It was allowed to reduce the daily dose to 150 mg b.i.d. or 100 mg b.i.d. No dose increase was allowed after a dose reduction.

Once every 21 days 75 milligram (mg)/ square meters (m²) of docetaxel was administered intravenous (over one hour). It was also allowed to reduce the dose of this intravenous infusion to 60 mg/m² or 50 mg/m². Thereafter it was not allowed to increase the dose again.

Nintedanib Plus Docetaxel (Patient Disposition for Docetaxel)

Disposition for Nintedanib

Disposition for Docetaxel

Spots Global Cancer Trial Database for Nintedanib Plus Docetaxel in Japanese Patients With Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy

Trial Identification

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Study Description

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