Study of Itacitinib in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer

Conditions

• NSCLC (Non-small Cell Lung Carcinoma)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Itacitinib — DRUG
  Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.
• docetaxel — DRUG
  Administered as an intravenous infusion in the clinic at 75 mg/m\^2 Q3W for Part 1 of the study.

Study Details

The primary objectives of this study were to evaluate the safety and tolerability of itacitinib in combination with docetaxel and to select doses for further evaluation (Part 1, safety run-in portion), and to evaluate and compare the overall survival of subjects with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) when treated with itacitinib in combination with docetaxel versus docetaxel alone (Part 2, randomized portion).

Key Dates

Start date

Sep 24, 2014

Status verified

Apr 2026

Primary completion

Feb 29, 2016

Completion

Apr 5, 2016

Study Design

Enrollment

9 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Itacitinib plus docetaxel
  Itacitinib 400 mg QD administered orally in combination with docetaxel 75 mg/m\^2 once every 3 weeks (q3w) administered intravenously

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through 21 days; the end of cycle 1. ]

Locations (16)

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