A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS
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ClinicalTrials.gov Identifier: NCT03884829 |
Recruitment Status :
Recruiting
First Posted : March 21, 2019
Last Update Posted : April 25, 2022
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Condition or disease | Intervention/treatment | Phase |
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AML, Adult Myelodysplastic Syndromes ALL, Adult CML, Refractory CLL, Refractory | Drug: CYC140 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention 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) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Pharmacologic Study of CYC140, a Polo-like Kinase 1 Inhibitor, in Patients With Advanced Leukemias or Myelodysplastic Syndromes |
Actual Study Start Date : | March 25, 2019 |
Estimated Primary Completion Date : | April 2023 |
Estimated Study Completion Date : | September 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: CYC140 single agent
CYC140 will be administered as a single agent on Day 1 and Day 8 of each 3 week cycle
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Drug: CYC140
CYC140 single agent |
- Number of Patients who experience dose -limiting toxicity (DLT) [ Time Frame: At end of cycle 1 (each cycle is 21 days) ]
- Pharmacokinetic measurement - area under the curve (AUC) [ Time Frame: At the end of cycle 1 (each cycle is 21 days) ]plasma drug exposure area under the curve (AUC)
- Anti-tumor activity [ Time Frame: First dose of CYC140 to 4 weeks after the last dose of CYC140 ]complete remission, partial remission

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884829
Contact: Mark Kirschbaum, MD | 6263163394 | mkirschbaum@cyclacel.com |
United States, Texas | |
MD Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Hind Alazzawi 713-794-4823 halazzawi@mdanderson.org |
Principal Investigator: | Gautam Borthakur, MD | M.D. Anderson Cancer Center |
Responsible Party: | Cyclacel Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT03884829 |
Other Study ID Numbers: |
CYC140-01 |
First Posted: | March 21, 2019 Key Record Dates |
Last Update Posted: | April 25, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
AML, ALL, CLL, CML, MDS, advanced leukemias, leukemia |
Leukemia Preleukemia Myelodysplastic Syndromes Syndrome Disease Pathologic Processes |
Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |