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Colorectal CancerPhase 1/2M13DAPNCT02039336

Dacomitinib Plus PD-0325901 in Advanced KRAS Mutant NSCLC

A Phase 1/2 study testing Dacomitinib, PD-0325901 and Docetaxel in people with Colorectal Cancer, run by The Netherlands Cancer Institute at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Dacomitinib, PD-0325901 and Docetaxel
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
3 sitesNetherlands
Study dates
2 Apr 2014to 7 Aug 2018
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • The Netherlands Cancer Institute

    Amsterdam, 1066CX

  • Erasmus Medical Center Cancer Institute

    Rotterdam, 3015CE

  • University Medical Center Utrecht

    Utrecht, 3584CX

Other trials in Netherlands

About this study

Official title: Phase I/II Study With the Combination of Dacomitinib and PD-0325901 in Metastatic KRAS Mutation Positive Non-small Cell Lung Cancer

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.

Being tested
Dacomitinib, PD-0325901, Docetaxel
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02039336
Study groupRoleWhat they receive
Dacomitinib + PD-0325901ExperimentalDacomitinib: oral tablets PD-0325901: oral capsules
Receives: Drug: Dacomitinib; Drug: PD-0325901; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of dose-limiting toxicities

    Measured: 1.5 years

  2. Progression free survival

    Measured: 2.5 years

Secondary outcomes (6)

  1. Incidence and severity of adverse events

    Measured: 2.5 years

  2. Plasma concentration

    Measured: 2.5 years

  3. Overall response rate

    Measured: 2.5 years

  4. Duration of response

    Measured: 1.5 years

  5. Time to response

    Measured: 2.5 years

  6. Overall survival

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2014 (estimated)
  2. Study start2 Apr 2014
  3. Primary completion7 Aug 2018
  4. Study completion7 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02039336
Sponsor's protocol ID
NL45985.031.13
Acronym
M13DAP
Status last verified
Jul 2025
First submitted
15 Jan 2014
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No

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.

    PubMed 32147669

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dacomitinib, PD-0325901 and Docetaxel in people with Colorectal Cancer, run by The Netherlands Cancer Institute at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of dose-limiting toxicities (time frame: 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02039336, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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