A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS

NCT03884829 | Terminated Phase 1 FDA Drug

• 1 other identifier: CYC140-01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I Pharmacologic Study of CYC140, a polo-like kinase 1 inhibitor, in Patients with Advanced Leukemias or Myelodysplastic Syndromes

Conditions

AML, Adult; Myelodysplastic Syndromes; ALL, Adult; CML, Refractory; CLL, Refractory

Keywords

AML, ALL, CLL, CML, MDS, advanced leukemias, leukemia

Outcome Measures

Primary Outcomes (1)

• Number of Patients who experience dose -limiting toxicity (DLT)

  At end of cycle 1 (each cycle is 21 days)

Secondary Outcomes (1)

• Pharmacokinetic measurement - area under the curve (AUC)

  At the end of cycle 1 (each cycle is 21 days)

Other Outcomes (1)

• Anti-tumor activity

  First dose of CYC140 to 4 weeks after the last dose of CYC140

Study Arms (1)

CYC140 single agent

EXPERIMENTAL

CYC140 will be administered as a single agent on Day 1 and Day 8 of each 3 week cycle

Drug: CYC140

Interventions

CYC140 DRUG

CYC140 single agent

CYC140 single agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyclacel Pharmaceuticals, Inc.: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Gautam Borthakur, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: March 21, 2019
• Study Start: March 25, 2019
• Primary Completion: November 29, 2021
• Study Completion: October 19, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)