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Head and Neck NeoplasmsPhase 1NCT02555644

A Study of Prexasertib (LY2606368) With Chemotherapy and Radiation in Participants With Head and Neck Cancer

A Phase 1 study testing Prexasertib, Cisplatin and Cetuximab in people with Head and Neck Neoplasms, run by Eli Lilly and Company at 4 sites in 2 countries.

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

The main purpose of this study is to investigate the safety of prexasertib in combination with other anti-cancer drugs (cisplatin or cetuximab) and radiation therapy in participants with locally advanced head and neck cancer. The study has two parts (A and B). Participants will only enroll in one part. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Neoplasms
What is being tested?
Prexasertib, Cisplatin and Cetuximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
4 sitesin 2 countries
Study dates
24 Feb 2016to 14 Jan 2019
Phase
Phase 1
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

  • Must be able to comply with the treatment plan and follow-up schedule
  • Must have diagnosis of head and neck squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls), hypopharynx, or larynx
  • Have adequate organ function
  • If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for six months following the last dose of study drug
  • If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding

Who cannot join

  • Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment
  • Must not have received any of the following prior therapies or treatments: systemic therapy for the study cancer, radiation therapy to the head and neck region, or curative-intent surgery in the head and neck region
  • Have evidence of a distant metastatic disease
  • Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C
  • Must not have a serious heart condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last three months
  • Must not have a family history of long corrected QT interval (QTc) syndrome
  • Must not have known allergic reaction against any of the components of the study treatment

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States2 sites

  • University of Alabama at Birmingham Medical Center

    Birmingham, Alabama, 35249

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

France2 sites

  • Centre Leon Berard

    Lyon, 69008

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: A Phase 1b Trial of LY2606368 in Combination With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Cancer

The main purpose of this study is to investigate the safety of prexasertib in combination with other anti-cancer drugs (cisplatin or cetuximab) and radiation therapy in participants with locally advanced head and neck cancer. The study has two parts (A and B). Participants will only enroll in one part.

Read the detailed description

The primary purpose of Parts A and B of this study is to determine a recommended dose level of prexasertib (an inhibitor of checkpoint kinase 1[Chk-1]) in combination with cisplatin and radiation therapy (Part A) or cetuximab and radiation therapy (Part B) in participants with locally advanced head and neck cancer.

Being tested
Prexasertib, Cisplatin, Cetuximab, Intensity Modulated Radiation Therapy
Keywords
cancer
Medical subject headings
Head and Neck Neoplasms, Neoplasms

What participants receive

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

  • PrexasertibDrug

    Also called LY2606368

    Administered IV

  • CisplatinDrug

    Administered IV

  • CetuximabDrug

    Also called Erbitux, LY2939777

    Administered IV

  • Intensity Modulated Radiation TherapyRadiation

Study groups in NCT02555644
Study groupRoleWhat they receive
Prexasertib + Cisplatin + Radiation Therapy (Part A)ExperimentalPrexasertib administered intravenously (IV) every 14 days over an approximately 49-day treatment period. Cisplatin administered IV every 7 days over an approximately 49-day treatment period. Intensity modulated radiation therapy administered 5 days per week over an approximately 49-day treatment period. Participants may remain on treatment until completion of the treatment period.
Receives: Drug: Prexasertib; Drug: Cisplatin; Radiation: Intensity Modulated Radiation Therapy
Prexasertib + Cetuximab + Radiation Therapy (Part B)ExperimentalPrexasertib administered IV every 14 days over an approximately 56-day treatment period. Cetuximab administered IV every 7 days over an approximately 56-day treatment period. Intensity modulated radiation therapy administered 5 days per week over an approximately 56-day treatment period (starting at Week 2). Participants may remain on treatment until completion of the treatment period.
Receives: Drug: Prexasertib; Drug: Cetuximab; Radiation: Intensity Modulated Radiation Therapy

What is being measured

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

  1. Part A: Maximum Tolerated Dose of Prexasertib in Combination with Cisplatin and Radiation Therapy

    Measured: First Dose through Last Dose (Estimated up to 7 Weeks)

  2. Part B: Maximum Tolerated Dose of Prexasertib in Combination with Cetuximab and Radiation Therapy

    Measured: First Dose through Last Dose (Estimated up to 8 Weeks)

Secondary outcomes (3)

  1. Pharmacokinetics (PK): Maximum Concentration of Prexasertib, Cisplatin and Cetuximab

    Measured: First Dose through Last Dose (Estimated up to 8 Weeks)

  2. PK: Area Under the Concentration Curve (AUC) of Prexasertib

    Measured: First Dose through Last Dose (Estimated up to 8 Weeks)

  3. Locoregional Control Rate

    Measured: Baseline through One Year (Estimated as up to 52 Weeks) or Death from Any Cause

Timeline

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

  1. First posted21 Sep 2015 (estimated)
  2. Study start24 Feb 2016
  3. Primary completion14 Jan 2019
  4. Study completion14 Jan 2019

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02555644
Sponsor's protocol ID
16016
Other IDs
I4D-MC-JTJI, 2015-001215-12, 2015
Status last verified
1 Feb 2019
First submitted
18 Sep 2015
Last updated
15 Feb 2019
Results posted
No
Data monitoring committee
No

Publications

  • Zeng L, Nikolaev A, Xing C, Della Manna DL, Yang ES. CHK1/2 Inhibitor Prexasertib Suppresses NOTCH Signaling and Enhances Cytotoxicity of Cisplatin and Radiation in Head and Neck Squamous Cell Carcinoma. Mol Cancer Ther. 2020 Jun;19(6):1279-1288. doi: 10.1158/1535-7163.MCT-19-0946. Epub 2020 May 5.

    PubMed 32371584

  • Zeng L, Beggs RR, Cooper TS, Weaver AN, Yang ES. Combining Chk1/2 Inhibition with Cetuximab and Radiation Enhances In Vitro and In Vivo Cytotoxicity in Head and Neck Squamous Cell Carcinoma. Mol Cancer Ther. 2017 Apr;16(4):591-600. doi: 10.1158/1535-7163.MCT-16-0352. Epub 2017 Jan 30.

    PubMed 28138028

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Prexasertib, Cisplatin and Cetuximab in people with Head and Neck Neoplasms, run by Eli Lilly and Company at 4 sites in 2 countries.

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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, France. 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 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.

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?

Part A: Maximum Tolerated Dose of Prexasertib in Combination with Cisplatin and Radiation Therapy (time frame: First Dose through Last Dose (Estimated up to 7 Weeks)). 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 NCT02555644, which also lists 2 linked publications.

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 15 Feb 2019.

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