Colorectal CancerPhase 1NCT03096054
A Phase I Trial of LY3143921 Hydrate in Solid Tumours
A Phase 1 study testing LY3143921 hydrate in people with Colorectal Cancer and High Grade Serous Ovarian Cancer, run by Cancer Research UK at 4 sites in United Kingdom.
Trial summary
This clinical study looked at a drug called LY3143921 hydrate (a Cdc7 inhibitor) in adult patients with advanced solid tumours. The main aims were to find out the maximum dose of LY3143921 hydrate that could be given safely to patients, and to assess the potential side effects and how they could be treated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, High Grade Serous Ovarian Cancer, Non Small-cell Lung Cancer (Squamous Cell Variant)
- What is being tested?
- LY3143921 hydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 21 Jun 2017to 9 Apr 2025
- 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
- Histologically proven advanced or metastatic solid tumours, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient.
- For Phase I Part 1 (dose escalation): Enriched for patients with tumours commonly associated with p53 mutation or loss of function:
- Colorectal cancer (CRC)
- High grade serous ovarian cancer
- Non small-cell lung cancer (NSCLC, squamous variant)
- Squamous carcinoma of the oesophagus
Show all 30Show fewer
- Squamous carcinoma of the head and neck (HPV negative)
- Urothelial cancer
- Breast cancer (triple negative type)
- Pancreatic cancer
- For Phase I Part 2 (expansion cohorts): Cohort 1: patients with metastatic CRC; Cohort 2: patients with squamous NSCLC and Cohort 3: patients with solid tumours commonly associated with p53 mutation or loss of function (as described above for the Phase 1 Part 1 part of the trial).
- Consent for pre-treatment and post-treatment fresh tumour biopsy samples in a minimum of six patients in expansion Cohorts 1 and 3, optional for all other patients.
- Consent for pre and post treatment skin punch biopsy in a minimum of six patients in each dose expansion cohort; optional in all remaining patients.
- Life expectancy of at least 12 weeks.
- Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
- World Health Organization performance status of 0 or 1
- Haematological and biochemical indices within the ranges shown below:
- Haemoglobin ≥9.0 g/dL (no prior transfusion within last 4 weeks) or ≥10.0 g/dL (transfusion within last 4 weeks)
- Absolute neutrophil count ≥1.5 x 10^9/L
- Platelet count ≥100 x 10^9/L
- Serum bilirubin ≤1.5 x upper limit of normal (ULN)
- Alanine aminotransferase and aspartate aminotransferase
- 2.5 x (ULN) (or ≤5 x ULN in the presence of liver metastasis)
- Calculated creatinine clearance (using the Wright or Cockcroft-Gault formula) ≥50 mL/min
- Prothrombin time and activated partial thromboplastin time** ≤1.5 x ULN
- Albumin ≥80% of the lower limit of normal
- Therapeutic International Normalised Ratio values (2.0 - 3.0) are acceptable to confirm eligibility for patients who are taking concomitant warfarin or other anticoagulants.
- Age 18 years or over.
- Consent must be given for use of archived tumour samples for all patients.
- Disease must be either evaluable or measurable using RECIST version 1.1 criteria.
Who cannot join
- Systemic anti-cancer therapy (with the exception of life-long hormone suppression such as luteinising hormone-releasing hormone agents in prostate cancer) or another investigational agent during the previous 4 weeks (6 weeks for nitrosureas, Mitomycin-C) is not permitted. Previous use of radiotherapy is permitted except where there has been a large volume of bone marrow irradiated or where the irradiated lesion is the only one suitable for RECIST measurability.
- Ongoing toxic manifestations of previous treatments (Grade 2 or greater according to NCI-CTCAE version 4.02) with the exception of alopecia or certain Grade 2 toxicities, which in the opinion of the investigator and Sponsor should not exclude the patient - these should be discussed on a case by case basis.
- Symptomatic brain metastases or spinal cord compression.
- Significant baseline hypotension or symptomatic hypotension at any level of BP (<90 mmgHg systolic or <50 mmHg diastolic).
- Uncontrolled hypertension (>160 mmHg/100 mmHg).
- Patients with a known left ventricular ejection fraction <50%. An echocardiogram must be performed in all patients.
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- Women of child-bearing potential (or who are already pregnant or lactating). However, those patients who meet the following points are considered eligible:
- Have a negative serum or urine pregnancy test before enrolment and;
- Agree to use two forms of contraception (one effective form plus a barrier method [oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom]) or agree to sexual abstinence, effective from the first administration of LY3143921 hydrate, throughout the trial and for 6 months afterwards.
- Male patients with partners of child-bearing potential. However, those patients who meet the following points are considered eligible:
- Agree to take measures not to father children by using a barrier method of contraception [condom plus spermicide] or to sexual abstinence effective from the first administration of LY3143921 hydrate, throughout the trial and for 6 months afterwards.
- Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intra-uterine device, diaphragm with spermicidal gel or sexual abstinence.
- Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate.
- No major surgery within 4 weeks prior to the patient receiving Cycle 1 Day -7 (for dose escalation) or Cycle 1 Day 1 (for dose expansion). If minor surgery has been performed within 2 weeks of the start of trial treatment then patients must have recovered, and the sponsor and Chief Investigator should be notified of the nature of this and agree to patient inclusion.
- At high medical risk because of non-malignant systemic disease including active uncontrolled infection.
- Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (mandatory testing not required).
- Significant cardiovascular disease as defined by:
- History of congestive heart failure requiring therapy
- History of unstable angina pectoris or myocardial infarction up to 6 months prior to trial entry
- Presence of severe valvular heart disease
- Presence of a ventricular arrhythmia requiring treatment
- Past history of corneal ulceration, dry eye syndrome, glaucoma. Contact lenses should also be avoided during participation in the trial.
- Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this Phase I study of LY3143921 hydrate. Participation in an observational trial or interventional clinical trial which does not involve administration of an IMP and which would not place an unacceptable burden on the patient in the opinion of the Investigator and Sponsor's Medical Advisor would be acceptable.
- Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Northern Ireland Cancer Centre
Belfast, BT9 7JL
Western General Hospital
Edinburgh, EH4 2XU
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Northern Centre for Cancer Care
Newcastle upon Tyne, NE7 7DN
About this study
Official title: A Cancer Research UK Phase I Trial of LY3143921 Hydrate (a Cdc7 Inhibitor) Given Orally in Adult Patients With Advanced Solid Tumours
This clinical study looked at a drug called LY3143921 hydrate (a Cdc7 inhibitor) in adult patients with advanced solid tumours. The main aims were to find out the maximum dose of LY3143921 hydrate that could be given safely to patients, and to assess the potential side effects and how they could be treated.
Read the detailed description
This clinical study looked at a drug called LY3143921 hydrate, which is a Cdc7 inhibitor. Cdc7 helps our cells replicate correctly. Cdc7 is usually found at a low level in normal cells but can reach higher levels in cancer cells. This is often the case in certain types of solid tumour cancers, which we focused on in this study. It was thought that giving LY3143921 hydrate would block the function of Cdc7 and would affect cancer cells by stopping their replication and causing them to die. LY3143921 hydrate looked promising in laboratory studies and studies in animals.
This clinical study had two parts:
Part 1 - a 'dose escalation' phase where groups of patients received increasing doses of LY3143921 hydrate to find a safe dose and a dose that best targeted the cancer cells.
Part 2 - an 'expansion' phase where a larger group of patients received the highest dose of LY3143921 hydrate considered to be safe from Part 1, to find out more about how the drug was working.
- Conditions
- Colorectal Cancer, High Grade Serous Ovarian Cancer, Non Small-cell Lung Cancer (Squamous Cell Variant), Urothelial Cancer, Breast Cancer (Triple Negative Type), Pancreatic Cancer
- Being tested
- LY3143921 hydrate
- Medical subject headings
- Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Pancreatic Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3143921 hydrateDrug
LY3143921 hydrate was administered orally on a daily schedule. Each cycle of treatment consisted of 21 days, and patients may have initially received up to 12 cycles. If the patient was benefitting, they may have continued beyond 12 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 a dose escalation | Experimental | Phase where groups of patients received increasing doses of LY3143921 hydrate to find a safe dose and a dose that best targeted the cancer cells. Receives: Drug: LY3143921 hydrate |
| Part 2 an expansion | Experimental | Phase where a larger group of patients received the highest dose of LY3143921 hydrate considered to be safe from Part 1, to find out more about how the drug worked. Receives: Drug: LY3143921 hydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the maximum tolerated dose (MTD)
The maximal dose was determined as the dose at which no more than one patient out of up to six patients at the same dose level experienced a highly probable or probable drug-related dose-limiting toxicity (DLT), and the schedule of administration at which the maximum tolerated dose (MTD) was established was determined.
Measured: 28 days from first administration of LY3143921 hydrate in the dose escalation cohort, including the single dose on Cycle 1 Day -7.
Determination of adverse event (AE) causality and grade
The causality of each AE and grade to LY3143921 hydrate was determined according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.02.
Measured: From first administration of LY3143921 hydrate until last patient's last visit (LPLV).
Secondary outcomes (8)
Determine the maximum observed plasma concentration (Cmax) of LY3143921
Plasma samples were analysed to determine the Cmax of LY3143921 following oral administration of LY3143921 hydrate, using liquid chromatography mass spectrometry (LCMS) according to agreed standard operating procedures (SOPs) and validate methods. Not all participants were analysed at all time points.
Measured: Up to 10 time points per patient per visit.
Determine the time to reach Cmax for LY3143921 (Tmax)
Plasma samples were analysed to determine the Tmax of LY3143921 following oral administration of LY3143921 hydrate, using LCMS according to agreed SOPs and validate methods. Not all participants were analysed at all time points.
Measured: Up to 10 time points per patient per visit.
Determine under the plasma-concentration time curve for LY3143921
Plasma samples were analysed to determine under the plasma-concentration time curve for LY3143921 following oral administration of LY3143921 hydrate, using LCMS according to agreed SOPs and validate methods. Not all participants were analysed at all time points.
Measured: Up to 10 time points per patient per visit.
Determine the plasma half-life of LY3143921
Plasma samples were analysed to determine the plasma half-life of LY3143921 following oral administration of LY3143921 hydrate, using LCMS according to agreed SOPs and validate methods. Not all participants were analysed at all time points.
Measured: Up to 10 time points per patient per visit.
Determine the volume of distribution for LY3143921
Plasma samples were analysed to determine the volume of distribution for LY3143921 following oral administration of LY3143921 hydrate, using LCMS according to agreed SOPs and validate methods. Not all participants were analysed at all time points.
Measured: Up to 10 time points per patient per visit.
Determine the clearance of LY3143921
Plasma samples were analysed to determine the clearance of LY3143921 following oral administration of LY3143921 hydrate, using LCMS according to agreed SOPs and validate methods. Not all participants were analysed at all time points.
Measured: Up to 10 time points per patient per visit.
Determine the overall response rate
The ratio of participants with any response to the total number of participants in the response population. A participant is considered a responder if assessed according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 as having either a complete response or partial response.
Measured: Tumour assessments at end of Cycle 2, then every 2 cycles (or more frequently) up to Cycle 70; thereafter every 8 cycles (±14 days) or more frequently until withdrawal.
Determine the median progression-free survival
The median (range) number of days from first administration of LY3143921 hydrate to documented disease progression measured according to RECIST version 1.1. Participants lost to follow-up or who withdrew consent for follow-up were censored at the time of last recorded disease assessment. Participants who started a new treatment were not censored.
Measured: Tumour assessments at end of Cycle 2, then every 2 cycles (or more frequently) up to Cycle 70; thereafter every 8 cycles (±14 days) or more frequently until withdrawal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start21 Jun 2017
- Primary completion9 Apr 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096054
- Sponsor's protocol ID
- CRUKD/17/004
- Other IDs
- 2016-001245-80, ISRCTN84044406, 2016
- Status last verified
- Aug 2026
- First submitted
- 15 Mar 2017
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cancer Research UK Phase I Trial of LY3143921 Hydrate (a Cdc7 Inhibitor) Given Orally in Adult Patients With Advanced Solid Tumours
- ClinicalTrials.gov ID
- NCT03096054
- Acronym / sponsor ID
- CRUKD/17/004
- Conditions
- Colorectal Cancer, High Grade Serous Ovarian Cancer, Non Small-cell Lung Cancer (Squamous Cell Variant), Urothelial Cancer, Breast Cancer (Triple Negative Type), Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 30 Mar 2017 (actual)
- 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.
This clinical study looked at a drug called LY3143921 hydrate (a Cdc7 inhibitor) in adult patients with advanced solid tumours. The main aims were to find out the maximum dose of LY3143921 hydrate that could be given safely to patients, and to assess the potential side effects and how they could be treated.
Detailed description
This clinical study looked at a drug called LY3143921 hydrate, which is a Cdc7 inhibitor. Cdc7 helps our cells replicate correctly. Cdc7 is usually found at a low level in normal cells but can reach higher levels in cancer cells. This is often the case in certain types of solid tumour cancers, which we focused on in this study. It was thought that giving LY3143921 hydrate would block the function of Cdc7 and would affect cancer cells by stopping their replication and causing them to die. LY3143921 hydrate looked promising in laboratory studies and studies in animals.
This clinical study had two parts:
Part 1 - a 'dose escalation' phase where groups of patients received increasing doses of LY3143921 hydrate to find a safe dose and a dose that best targeted the cancer cells.
Part 2 - an 'expansion' phase where a larger group of patients received the highest dose of LY3143921 hydrate considered to be safe from Part 1, to find out more about how the drug was working.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 a dose escalation | Experimental | Drug: LY3143921 hydratePhase where groups of patients received increasing doses of LY3143921 hydrate to find a safe dose and a dose that best targeted the cancer cells. |
| Part 2 an expansion | Experimental | Drug: LY3143921 hydratePhase where a larger group of patients received the highest dose of LY3143921 hydrate considered to be safe from Part 1, to find out more about how the drug worked. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Histologically proven advanced or metastatic solid tumours, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient.
- For Phase I Part 1 (dose escalation): Enriched for patients with tumours commonly associated with p53 mutation or loss of function:
- For Phase I Part 2 (expansion cohorts): Cohort 1: patients with metastatic CRC; Cohort 2: patients with squamous NSCLC and Cohort 3: patients with solid tumours commonly associated with p53 mutation or loss of function (as described above for the Phase 1 Part 1 part of the trial).
- Life expectancy of at least 12 weeks.
- Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
Key exclusion criteria (24 listed)
- Systemic anti-cancer therapy (with the exception of life-long hormone suppression such as luteinising hormone-releasing hormone agents in prostate cancer) or another investigational agent during the previous 4 weeks (6 weeks for nitrosureas, Mitomycin-C) is not permitted. Previous use of radiotherapy is permitted except where there has been a large volume of bone marrow irradiated or where the irradiated lesion is the only one suitable for RECIST measurability.
- Ongoing toxic manifestations of previous treatments (Grade 2 or greater according to NCI-CTCAE version 4.02) with the exception of alopecia or certain Grade 2 toxicities, which in the opinion of the investigator and Sponsor should not exclude the patient - these should be discussed on a case by case basis.
- Symptomatic brain metastases or spinal cord compression.
- Significant baseline hypotension or symptomatic hypotension at any level of BP (<90 mmgHg systolic or <50 mmHg diastolic).
- Uncontrolled hypertension (>160 mmHg/100 mmHg).
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 |
|---|---|---|
| LY3143921 hydrateLY3143921 hydrate was administered orally on a daily schedule. Each cycle of treatment consisted of 21 days, and patients may have initially received up to 12 cycles. If the patient was benefitting, they may have continued beyond 12 cycles. | Drug | Part 1 a dose escalation, Part 2 an expansion |
Primary outcome
Determination of the maximum tolerated dose (MTD)
Time frame: 28 days from first administration of LY3143921 hydrate in the dose escalation cohort, including the single dose on Cycle 1 Day -7.
The maximal dose was determined as the dose at which no more than one patient out of up to six patients at the same dose level experienced a highly probable or probable drug-related dose-limiting toxicity (DLT), and the schedule of administration at which the maximum tolerated dose (MTD) was established was determined.
Determination of adverse event (AE) causality and grade
Time frame: From first administration of LY3143921 hydrate until last patient's last visit (LPLV).
The causality of each AE and grade to LY3143921 hydrate was determined according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.02.
8 secondary outcomes
Determine the maximum observed plasma concentration (Cmax) of LY3143921
Time frame: Up to 10 time points per patient per visit.
Determine the time to reach Cmax for LY3143921 (Tmax)
Time frame: Up to 10 time points per patient per visit.
Determine under the plasma-concentration time curve for LY3143921
Time frame: Up to 10 time points per patient per visit.
Determine the plasma half-life of LY3143921
Time frame: Up to 10 time points per patient per visit.
Determine the volume of distribution for LY3143921
Time frame: Up to 10 time points per patient per visit.
Determine the clearance of LY3143921
Time frame: Up to 10 time points per patient per visit.
Determine the overall response rate
Time frame: Tumour assessments at end of Cycle 2, then every 2 cycles (or more frequently) up to Cycle 70; thereafter every 8 cycles (±14 days) or more frequently until withdrawal.
Determine the median progression-free survival
Time frame: Tumour assessments at end of Cycle 2, then every 2 cycles (or more frequently) up to Cycle 70; thereafter every 8 cycles (±14 days) or more frequently until withdrawal.
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 18 Aug 2026.
- LY3143921 ISRCTN Record (including basic results)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3143921 hydrate in people with Colorectal Cancer and High Grade Serous Ovarian Cancer, run by Cancer Research UK at 4 sites in United Kingdom.
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 30 inclusion and 24 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 18 Aug 2026. 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 Kingdom. 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?
Determination of the maximum tolerated dose (MTD) (time frame: 28 days from first administration of LY3143921 hydrate in the dose escalation cohort, including the single dose on Cycle 1 Day -7.). 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?
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 18 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.