M13DAP: Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

• Sponsor: The Netherlands Cancer Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02039336
• Collaborator: Pfizer (Industry)
• Enrollment: 35
• Locations: 3
• Arm: 1
• Duration (Months): 71
• Patients Per Site: 11.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: Dacomitinib; Drug: PD-0325901; Drug: Docetaxel	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Study With the Combination of Dacomitinib and PD-0325901 in Metastatic KRAS Mutation Positive Non-small Cell Lung Cancer
• Study Start Date: Jan 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2018
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dacomitinib + PD-0325901 Dacomitinib: oral tablets PD-0325901: oral capsules	Drug: Dacomitinib; Drug: PD-0325901; Drug: Docetaxel

Outcome Measures

Primary Outcome Measures

1. Incidence rate of dose-limiting toxicities [1.5 years]

2. Progression free survival [2.5 years]

Secondary Outcome Measures

1. Incidence and severity of adverse events [2.5 years]

2. Plasma concentration [2.5 years]

3. Overall response rate [2.5 years]

4. Duration of response [1.5 years]

5. Time to response [2.5 years]

6. Overall survival [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Netherlands Cancer Institute	Amsterdam		Netherlands	1066CX
2	Erasmus Medical Center Cancer Institute	Rotterdam		Netherlands	3015CE
3	University Medical Center Utrecht	Utrecht		Netherlands	3584CX

Sponsors and Collaborators

• The Netherlands Cancer Institute
• Pfizer

Investigators

• Study Director: f opdam, MD, PhD, The Netherlands Cancer Institute
• Principal Investigator: FALM Eskens, PhD, Erasmus Medical Centre Cancer Institute
• Principal Investigator: MPJK Lolkema, PhD, UMC Utrecht

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Netherlands Cancer Institute
• ClinicalTrials.gov Identifier: NCT02039336
• Other Study ID Numbers: NL45985.031.13
• First Posted: Jan 17, 2014
• Last Update Posted: Aug 27, 2018
• Last Verified: Aug 1, 2018

• Additional relevant MeSH terms: Colorectal Neoplasms; Docetaxel

Study Results

No Results Posted as of Aug 27, 2018