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Completed

NCT Number: NCT02552953

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

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

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

CYC065

Drug

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)

Sponsors and collaborators

Lead sponsor

Cyclacel Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2023
First posted
Sep 17, 2015
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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