Description:
This is a phase I/II multi-center open-label proof of concept study, consisting of two parts.
Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the
combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant
(KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized
comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy
in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy
the progression free survival of patients with KRASm NSCLC will be doubled.
Title
- Brief Title: Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC
- Official Title: Phase I/II Study With the Combination of Dacomitinib and PD-0325901 in Metastatic KRAS Mutation Positive Non-small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
NL45985.031.13
- NCT ID:
NCT02039336
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Dacomitinib | | Dacomitinib + PD-0325901 |
PD-0325901 | | Dacomitinib + PD-0325901 |
Docetaxel | | Dacomitinib + PD-0325901 |
Purpose
This is a phase I/II multi-center open-label proof of concept study, consisting of two parts.
Part A of this study is designed to identify the recommended phase 2 dose (RP2D) of the
combination regimen of dacomitinib plus PD-0325901 in patients with advanced KRAS mutant
(KRASm) non-small cell lung cancer (NSCLC). Part B is designed to perform a randomized
comparison of the combination of dacomitinib and PD-0325901 versus standard of care therapy
in patients with advanced KRASm NSCLC. It is hypothesized that with this combination strategy
the progression free survival of patients with KRASm NSCLC will be doubled.
Trial Arms
Name | Type | Description | Interventions |
---|
Dacomitinib + PD-0325901 | Experimental | Dacomitinib: oral tablets PD-0325901: oral capsules | - Dacomitinib
- PD-0325901
- Docetaxel
|
Eligibility Criteria
Inclusion Criteria:
- Histological or cytological proof of advanced non-small cell lung cancer
- Written documentation of KRAS (exon 2, 3 or 4) mutation
- At least 18 years of age or older
- Able and willing to give written informed consent
- WHO performance status of 0 or 1
Exclusion Criteria:
- Symptomatic or untreated leptomeningeal disease
- Symptomatic brain metastasis
- Impairment of gastrointestinal function
- Uncontrolled infectious disease
- Left ventricular ejection fraction < 50%
- Retinal degenerative disease or with history of uveitis, retinal vein occlusion or
retinal detachment
Other protocol-defined inclusion/exclusion criteria may apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence rate of dose-limiting toxicities |
Time Frame: | 1.5 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Incidence and severity of adverse events |
Time Frame: | 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Plasma concentration |
Time Frame: | 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Overall response rate |
Time Frame: | 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Duration of response |
Time Frame: | 1.5 years |
Safety Issue: | |
Description: | |
Measure: | Time to response |
Time Frame: | 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Unknown status |
Lead Sponsor: | The Netherlands Cancer Institute |
Last Updated
August 27, 2018