Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC
NCT02039336
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
0031205122446
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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Advanced Information
| Descriptive Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC | |||||||||
| Official Title ICMJE | Phase I/II Study With the Combination of Dacomitinib and PD-0325901 in Metastatic KRAS Mutation Positive Non-small Cell Lung Cancer | |||||||||
| 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. | |||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 1 Phase 2 | |||||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||||||||
| Condition ICMJE | Colorectal Cancer | |||||||||
| Intervention ICMJE |
| |||||||||
| Study Arms ICMJE | Experimental: Dacomitinib + PD-0325901
Dacomitinib: oral tablets PD-0325901: oral capsules Interventions:
| |||||||||
| Publications * | van Geel RMJM, van Brummelen EMJ, Eskens FALM, Huijberts SCFA, de Vos FYFL, Lolkema MPJK, Devriese LA, Opdam FL, Marchetti S, Steeghs N, Monkhorst K, Thijssen B, Rosing H, Huitema ADR, Beijnen JH, Bernards R, Schellens JHM. Phase 1 study of the pan-HER inhibitor dacomitinib plus the MEK1/2 inhibitor PD-0325901 in patients with KRAS-mutation-positive colorectal, non-small-cell lung and pancreatic cancer. Br J Cancer. 2020 Apr;122(8):1166-1174. doi: 10.1038/s41416-020-0776-z. Epub 2020 Mar 9. | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Unknown status | |||||||||
| Estimated Enrollment ICMJE | 35 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | December 2019 | |||||||||
| Estimated Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply | |||||||||
| Sex/Gender ICMJE |
| |||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Netherlands | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT02039336 | |||||||||
| Other Study ID Numbers ICMJE | NL45985.031.13 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | The Netherlands Cancer Institute | |||||||||
| Study Sponsor ICMJE | The Netherlands Cancer Institute | |||||||||
| Collaborators ICMJE | Pfizer | |||||||||
| Investigators ICMJE |
| |||||||||
| PRS Account | The Netherlands Cancer Institute | |||||||||
| Verification Date | August 2018 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||