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CompletedNCT02552953Updated May 31, 2024

A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers

A Phase 1 interventional study of CYC065 in Cancer, sponsored by Cyclacel Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-31.

Sponsored by Cyclacel Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is an open-label, single arm, dose escalation study in patients with advanced cancers.

Read the detailed description

This is an open-label, single arm, dose escalation study in patients with advanced cancers. Treatment will be administered on an outpatient basis.

02

Conditions studied

  • Cancer

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03

In context

Neoplasms

9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 7,432 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Cyclacel Pharmaceuticals, Inc. is the lead sponsor of 17 studies on the registry; 2 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histologically or cytologically confirmed solid tumors or lymphomas that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
  • 18 years or older
  • ECOG performance status 0-1
  • Life expectancy ≥ 3 months
  • Evaluable disease
  • Adequate organ functions
  • 4 weeks from prior chemotherapy ( 6 weeks for mitomycin C and nitrosourea) , immunotherapy, investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
  • At least 4 weeks from major surgery
  • Agree to practice effective contraception
  • Agree to follow protocol required evaluations
  • Ability to understand and willingness to sign the informed consent form

Exclusion criteria

Exclusion Criteria:

  • Previously untreated CNS metastasis or progressive CNS metastasis
  • Currently receiving radiotherapy, biological therapy, or any other investigational agents
  • Uncontrolled intercurrent illness
  • Pregnant or lactating women
  • Known to be HIV-positive
  • Known active hepatitis B and/or hepatitis C infection
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    CYC065 - 4 hour infusion (Part 1 completed)

    CYC065 will be administered by 4 -hour infusion every 3 weeks.

    Drug: CYC065

  • Experimental
    CYC065 - 1 hour infusion (Part 2 - ongoing)

    CYC065 will be administered by 1 - hour infusion on Days 1, 2, 8, and 9 every 3 weeks

    Drug: CYC065

  • Experimental
    CYC065 - Oral (Part 3 - ongoing)

    CYC065 will be administered orally on Days 1, 2, 8 and 9 every 3 weeks

    Drug: CYC065

Interventions

06

What researchers measure

Primary outcomes

  1. Number of patients who experience dose-limiting toxicities

    Time frame: cycle 1(each cycle is 21 -28 days)

Secondary outcomes

  1. Plasma concentrations

    Time frame: cycle 1(each cycle is 21 -28 days)

  2. Half-life of CYC065

    Time frame: cycle 1(each cycle is 21 -28 days)

  3. changes in certain protein levels in peripheral white blood cells by western blots

    Time frame: cycle 1(each cycle is 21 -28 days)

07

Study locations

1 site
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02552953
Lead sponsor
Cyclacel Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Sep 17, 2015
Start date
Sep 28, 2015
Primary completion
Oct 4, 2022
Completion
Aug 25, 2023
Last update
May 31, 2024

Study contacts

Geoffrey Shapiro, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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