Advanced CancerPhase 1NCT02860780
A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic Cancer
A Phase 1 study testing prexasertib and ralimetinib in people with Advanced Cancer and Metastatic Cancer, run by Eli Lilly and Company at 3 sites in 2 countries.
Trial summary
The main purpose of this study is to evaluate the safety of the study drug prexasertib in combination with ralimetinib in participants with advanced or metastatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Cancer, Colorectal Cancer
- What is being tested?
- prexasertib and ralimetinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Aug 2016to 15 May 2017
- 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
- Advanced or metastatic cancer.
- Able to swallow tablets.
- For Part B, you will need to have colon cancer or non-small cell lung (NSCLC) cancer with KRAS and/or BRAF mutations.
- Discontinued all previous treatments for cancer and recovered from the acute effects from the therapy.
Who cannot join
- Active infection (fungal, viral, or bacterial).
- Active cancer in your brain or spinal cord.
- Acute or chronic leukemia.
- Serious heart condition.
- Disease that requires immunosuppressant therapy.
- Diagnosis of inflammatory bowel disease.
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- Major small bowel resection that interferes with your body's ability to absorb the oral medicine.
- Participated in other clinical trials investigating prexasertib or ralimetinib.
- Pregnant or breastfeeding.
- Other pre-existing conditions or medical history which your doctor will explain to you.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Carolinas Medical Center
Charlotte, North Carolina, 28204
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, 37203
Germany1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cologne, 50937
About this study
Official title: A Phase 1 Dose-Escalation Study of LY2606368 in Combination With Ralimetinib in Patients With Advanced or Metastatic Cancer
The main purpose of this study is to evaluate the safety of the study drug prexasertib in combination with ralimetinib in participants with advanced or metastatic cancer.
- Being tested
- prexasertib, ralimetinib
- Medical subject headings
- Neoplasm Metastasis, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung
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
ralimetinibDrug
Also called LY2228820
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part A: prexasertib + ralimetinib | Experimental | Cohort 1: 60 milligrams (mg) prexasertib (LY2606368) given intravenously (IV) and 100 mg ralimetinib given orally.
Cohort 2: 60 mg prexasertib (LY2606368) given intravenously (IV) and 200 mg ralimetinib given orally. Receives: Drug: prexasertib; Drug: ralimetinib |
| Part B1: prexasertib + ralimetinib (colorectal cancer) | Experimental | 60 mg prexasertib (LY2696368) given IV and 200 mg ralimetinib given orally. Participants receive prexasertib IV on Days 1 and 15 and ralimetinib every 12 hours (Q12H) Days 1 and 14 of a 28 day cycle. Receives: Drug: prexasertib; Drug: ralimetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib
Measured: Cycle 1 (28 Days)
Secondary outcomes (8)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib
Measured: Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles)
PK: Area Under the Curve (AUC) of Prexasertib
Measured: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: Cmax of Ralimetinib
Measured: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of Ralimetinib
Measured: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Best Overall Response (BOR): Percentage of Participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE)
Measured: Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Estimated up to 32 Weeks)
Disease Control Rate (DCR): Percentage of Participants who Exhibit SD, CR or PR
Measured: Baseline through Measured Progressive Disease (Estimated up to 32 Weeks)
Duration of Response (DOR)
Measured: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 32 Weeks)
Progression Free Survival (PFS)
Measured: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 32 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start10 Aug 2016
- Primary completion15 May 2017
- Study completion15 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860780
- Sponsor's protocol ID
- 16379
- Other IDs
- I4D-MC-JTJL, 2015-005611-33, 2015
- Status last verified
- Nov 2017
- First submitted
- 5 Aug 2016
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose-Escalation Study of LY2606368 in Combination With Ralimetinib in Patients With Advanced or Metastatic Cancer
- ClinicalTrials.gov ID
- NCT02860780
- Acronym / sponsor ID
- 16379
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the safety of the study drug prexasertib in combination with ralimetinib in participants with advanced or metastatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: prexasertib + ralimetinib | Experimental | Drug: prexasertib, Drug: ralimetinibCohort 1: 60 milligrams (mg) prexasertib (LY2606368) given intravenously (IV) and 100 mg ralimetinib given orally. Cohort 2: 60 mg prexasertib (LY2606368) given intravenously (IV) and 200 mg ralimetinib given orally. |
| Part B1: prexasertib + ralimetinib (colorectal cancer) | Experimental | Drug: prexasertib, Drug: ralimetinib60 mg prexasertib (LY2696368) given IV and 200 mg ralimetinib given orally. Participants receive prexasertib IV on Days 1 and 15 and ralimetinib every 12 hours (Q12H) Days 1 and 14 of a 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced or metastatic cancer.
- Able to swallow tablets.
- For Part B, you will need to have colon cancer or non-small cell lung (NSCLC) cancer with KRAS and/or BRAF mutations.
- Discontinued all previous treatments for cancer and recovered from the acute effects from the therapy.
Key exclusion criteria (10 listed)
- Active infection (fungal, viral, or bacterial).
- Active cancer in your brain or spinal cord.
- Acute or chronic leukemia.
- Serious heart condition.
- Disease that requires immunosuppressant therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prexasertibAlso: LY2606368Administered IV | Drug | Part A: prexasertib + ralimetinib, Part B1: prexasertib + ralimetinib (colorectal cancer) |
| ralimetinibAlso: LY2228820Administered orally | Drug | Part A: prexasertib + ralimetinib, Part B1: prexasertib + ralimetinib (colorectal cancer) |
Primary outcome
Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib
Time frame: Cycle 1 (28 Days)
8 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Prexasertib
Time frame: Cycle 1 Day 1 through Cycle 3 Day 1 (28 Day Cycles)
PK: Area Under the Curve (AUC) of Prexasertib
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: Cmax of Ralimetinib
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
PK: AUC of Ralimetinib
Time frame: Cycle 1 Day 1 through Cycle 2 Day 1 (28 Day Cycles)
Best Overall Response (BOR): Percentage of Participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), or Not Evaluable (NE)
Time frame: Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Estimated up to 32 Weeks)
Disease Control Rate (DCR): Percentage of Participants who Exhibit SD, CR or PR
Time frame: Baseline through Measured Progressive Disease (Estimated up to 32 Weeks)
Duration of Response (DOR)
Time frame: Date of CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 32 Weeks)
Progression Free Survival (PFS)
Time frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated Up to 32 Weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Click here for more information about this study: A Study of Prexasertib (LY2606368) in Combination With Ralimetinib in Participants With Advanced or Metastatic CancerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing prexasertib and ralimetinib in people with Advanced Cancer and Metastatic Cancer, run by Eli Lilly and Company at 3 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 4 inclusion and 10 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 14 Dec 2018. 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 United States, Germany. 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?
Maximum Tolerated Dose (MTD) of Prexasertib and Ralimetinib (time frame: Cycle 1 (28 Days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2018.