AML, AdultPhase 1NCT03884829
A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS
A Phase 1 study testing CYC140 in people with AML, Adult and Myelodysplastic Syndromes, run by Cyclacel Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
A Phase I Pharmacologic Study of CYC140, a polo-like kinase 1 inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Adult, Myelodysplastic Syndromes, ALL, Adult
- What is being tested?
- CYC140
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 19 Oct 2023
- 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
- Diagnosis of relapsed or refractory advanced leukemias or MDS
- ECOG 0-2
- Adequate renal function
- Adequate liver function
- ≥ 2 weeks from prior chemotherapy, radiation therapy or major surgery
- ≥ 4 weeks from other investigational anticancer therapy
- Agree to practice effective contraception
Who cannot join
- Known CNS involvement by leukemia
- Currently receiving radiotherapy, biological therapy, or any other investigational agents
- Uncontrolled intercurrent illness
- Pregnant or lactating
- Known to be HIV-positive
- Known active hepatitis B and/ or hepatitis C infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Pharmacologic Study of CYC140, a Polo-like Kinase 1 Inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes
A Phase I Pharmacologic Study of CYC140, a polo-like kinase 1 inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes
Read the detailed description
This is a First in Human, open-label, single arm, dose escalation study in patients with advanced leukemias or myelodysplastic syndromes. Patients will receive CYC140 as a 1 hr infusion once a week for 2 weeks followed by 1 week of rest on an outpatient basis. One treatment cycle is 3 weeks.
- Being tested
- CYC140
- Keywords
- AML, ALL, CLL, CML, MDS, advanced leukemias, leukemia
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYC140Drug
CYC140 single agent
| Study group | Role | What they receive |
|---|---|---|
| CYC140 single agent | Experimental | CYC140 will be administered as a single agent on Day 1 and Day 8 of each 3 week cycle Receives: Drug: CYC140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients who experience dose -limiting toxicity (DLT)
Measured: At end of cycle 1 (each cycle is 21 days)
Secondary outcomes (1)
Pharmacokinetic measurement - area under the curve (AUC)
plasma drug exposure area under the curve (AUC)
Measured: At the end of cycle 1 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start25 Mar 2019
- Primary completion29 Nov 2021
- Study completion19 Oct 2023
Why it stopped: Switch to oral formulation of CYC140 (plogosertib)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- One to three patients will be entered at a given dose level of CYC140. During the first cycle, all patients will be evaluated for DLTs. If DLT occurs, additional patients (up to 3) will be dosed at that dose. If no additional DLTs observed, dose escalation will continue per protocol. If a DLT does occur, dose escalation will be stopped. At least 6 patients will be treated at the RD to confirm its tolerability.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Gautam Borthakur, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884829
- Sponsor's protocol ID
- CYC140-01
- Status last verified
- Sep 2024
- First submitted
- 28 Oct 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pharmacologic Study of CYC140, a Polo-like Kinase 1 Inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT03884829
- Acronym / sponsor ID
- CYC140-01
- Keywords
- AML, ALL, CLL, CML, MDS, advanced leukemias, leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Switch to oral formulation of CYC140 (plogosertib)
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 21 Mar 2019 (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.
A Phase I Pharmacologic Study of CYC140, a polo-like kinase 1 inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes
Detailed description
This is a First in Human, open-label, single arm, dose escalation study in patients with advanced leukemias or myelodysplastic syndromes. Patients will receive CYC140 as a 1 hr infusion once a week for 2 weeks followed by 1 week of rest on an outpatient basis. One treatment cycle is 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One to three patients will be entered at a given dose level of CYC140. During the first cycle, all patients will be evaluated for DLTs. If DLT occurs, additional patients (up to 3) will be dosed at that dose. If no additional DLTs observed, dose escalation will continue per protocol. If a DLT does occur, dose escalation will be stopped. At least 6 patients will be treated at the RD to confirm its tolerability.
| Arm | Type | Receives |
|---|---|---|
| CYC140 single agent | Experimental | Drug: CYC140CYC140 will be administered as a single agent on Day 1 and Day 8 of each 3 week cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of relapsed or refractory advanced leukemias or MDS
- ECOG 0-2
- Adequate renal function
- Adequate liver function
- ≥ 2 weeks from prior chemotherapy, radiation therapy or major surgery
Key exclusion criteria (6 listed)
- Known CNS involvement by leukemia
- Currently receiving radiotherapy, biological therapy, or any other investigational agents
- Uncontrolled intercurrent illness
- Pregnant or lactating
- Known to be HIV-positive
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 |
|---|---|---|
| CYC140CYC140 single agent | Drug | CYC140 single agent |
Primary outcome
Number of Patients who experience dose -limiting toxicity (DLT)
Time frame: At end of cycle 1 (each cycle is 21 days)
1 secondary outcome
Pharmacokinetic measurement - area under the curve (AUC)
Time frame: At the end of cycle 1 (each cycle is 21 days)
Results and safety
The study was stopped early (reason given: Switch to oral formulation of CYC140 (plogosertib)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Gautam Borthakur, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CYC140 in people with AML, Adult and Myelodysplastic Syndromes, run by Cyclacel Pharmaceuticals, Inc. at 1 site in United States.
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 7 inclusion and 6 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: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 was stopped early (reason given: Switch to oral formulation of CYC140 (plogosertib)). Results are not available in the source record.
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?
Number of Patients who experience dose -limiting toxicity (DLT) (time frame: At end of cycle 1 (each cycle is 21 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 19 Sep 2024.