Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668393
• Other study ID #: 1199.224
• Secondary ID: 2015-000317-52
• Status: Completed
• Phase: Phase 1
• Start date: March 7, 2016
• Est. completion date: November 27, 2019

Study information

• Verified date: January 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 27, 2019
• Est. primary completion date: November 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

-Patients with histologically/ cytologically confirmed locally advanced (Stage IIIB) or metastatic (Stage IV) lung adeno carcinoma after failure of first line platinum - based chemotherapy (patients with non-target lesion only are eligible). First line chemotherapy may include continuation or switch maintenance therapy. One prior adjuvant and/or neoadjuvant chemotherapy line is accepted. Prior immunotherapy is allowed.

• ECOG inferior or equal to 1 at screening.
• Further inclusion criteria apply

Exclusion criteria:

• Patients who have received more than one prior line of chemotherapy (i.e. second or third line chemotherapy) for advanced or metastatic NSCLC.
• Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or patients known to be positive for ALK translocation
• Further exclusion criteria apply.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Docetaxel

• Nintedanib
Low Dose
• Nintedanib
Medium dose
• Nintedanib
High dose
• Nintedanib
Continuous high dose

Locations

Country	Name	City	State
France	HOP d'Angers	Angers
France	HOP Jean Minjoz	Besançon
Germany	Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH	Großhansdorf
Germany	Krankenhaus Martha-Maria Halle-Dölau gGmbH	Halle/Saale

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) of Nintedanib Administered in Combination With Docetaxel	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.	First treatment cycle, the first 28 days following the start of trial medication.
Primary	Number of Participants With Dose-limiting Toxicity (DLT) During the First Treatment Cycle	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.	First treatment cycle, the first 28 days following the start of trial medication.

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