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

Cyclacel Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: CYC065

Study type: Interventional

Funder types: Industry

Identifiers

NCT02552953

CYC065-01

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

CYC065 - 4 hour infusion (Part 1 completed)

Experimental group

Description:

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

Treatment:

Drug: CYC065

CYC065 - 1 hour infusion (Part 2 - ongoing)

Experimental group

Description:

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

Treatment:

Drug: CYC065

CYC065 - Oral (Part 3 - ongoing)

Experimental group

Description:

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

Treatment:

Drug: CYC065