Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Adenocarcinoma of Lung

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Lung Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Nintedanib

Tubulin Modulators

Antimitotic Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Nintedanib continuous high dose with docetaxel

Boehringer Ingelheim

Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel in patients with locally advanced or metastatic lung adenocarcinoma after failure of platinum-based first line chemotherapy.

Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

An Open Label Phase I of Oral Nintedanib Plus Weekly Docetaxel Therapy in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma After Failure of Platinum -Based First Line Chemotherapy

Maximum tolerated dose (MTD) of nintedanib administered in combination with docetaxel. The MTD was defined as the highest dose combination studied for which the incidence of DLTs was no more than 1 out of 6 subjects experiencing a DLT during the first treatment cycle i.e. the incidence of DLTs was no more than 17%. In case dose escalation reached dose level 3 (200 mg bid nintedanib administered without interruption on days of docetaxel infusion) and no more than 1 out of 6 subjects experienced a DLT during the first 28-day cycle at this dose level, dose level 3 was considered the MTD.

Number of participants with DLT occurring during the first treatment cycle. DLT was defined as any of the following adverse events related to nintedanib:

* Non-haematological drug-related Common Terminology Criteria for AEs (CTCAE) grade 3 or greater
* diarrhoea CTCAE grade 2 for \>7 days despite supportive care
* nausea CTCAE grade 3 or greater despite supportive care
* vomiting CTCAE grade 2 or greater despite supportive care
* increase in Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) to CTCAE grade 3 or greater
* A increase in ALT and/or AST to CTCAE grade 2 or greater in conjunction with
* total bilirubin increase of CTCAE grade 1 or greater
* Platelets \<50 000/mm3 with bleeding (CTCAE ≥3)
* neutropenia of any grade or duration accompanied by fever \>38.5°C
* neutropenia grade 4 without fever of \>7 days duration
* Inability to resume nintedanib dosing within 21 days after stopping due to toxicity.

Treated set (TS): all subjects who received at least one dose of study medication. The TS was used for all safety and efficacy analyses.

In a treatment cycle of 28 days, 150 milligram (mg) nintedanib was administered orally twice a day with a dose interval of 12 hours with 250 milliliter (mL) of water after food intake except on the days of docetaxel infusion. Docetaxel (35 mg per square meter of body surface (mg/m2)) was administrated as a intravenous infusion over 60 minutes on Days 1, 8 and 15. The 28-day treatment cycles could be repeated until disease progression. In case of nintedanib-related adverse events, the dose of nintedanib was to be reduced to 100 mg twice a day, a second dose reduction was not allowed.

150 mg Nintedanib + Docetaxel

In a treatment cycle of 28 days, 200 milligram (mg) nintedanib was administered orally twice a day with a dose interval of 12 hours with 250 milliliter (mL) of water after food intake except on the days of docetaxel infusion. Docetaxel (35 mg per square meter of body surface (mg/m2)) was administrated as a intravenous infusion over 60 minutes on Days 1, 8 and 15. The 28-day treatment cycles could be repeated until disease progression. In case of nintedanib-related adverse events, the dose of nintedanib was to be reduced to 150 mg twice a day with a possible second dose reduction to 100 mg twice a day.

200 mg Nintedanib + Docetaxel

Total

Age, Continuous

Sex: Female, Male

White

Not reported due to local law restrictions

Race/Ethnicity, Customized

Not Hispanic or Latino

Treated set (TS): all subjects who received at least one dose of study medication. The TS was used for all safety and efficacy analyses

Recruitment was prematurely discontinued after dose level 2 (200 milligram) due to difficulties in recruiting subjects.

Boehringer Ingelheim, Call Center

Comprises all dose cohorts during the dose escalation phase. In a treatment cycle of 28 days, 150 milligram (mg) nintedanib was taken orally twice a day with a dose interval of 12 hours with 250 milliliter (mL) of water after food intake except on the days of docetaxel infusion. Docetaxel (35 mg per square meter of body surface (mg/m2)) was administrated as a intravenous infusion over 60 minutes on Days 1, 8 and 15. The 28-day treatment cycles could be repeated until disease progression.

Nintedanib + Docetaxel

Maximum tolerated dose (MTD) Evaluation Set: All subjects who received at least one dose of study medication and were evaluable for MTD determination.

Spots Global Cancer Trial Database for Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

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