Description:
This is an open-label, single arm, dose escalation study in patients with advanced cancers.
Title
- Brief Title: A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers
- Official Title: A Phase I Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers
Clinical Trial IDs
- ORG STUDY ID:
CYC065-01
- NCT ID:
NCT02552953
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| CYC065 | | CYC065 - 1 hour infusion (Part 2 - ongoing) |
Purpose
This is an open-label, single arm, dose escalation study in patients with advanced cancers.
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| CYC065 - 4 hour infusion (Part 1 completed) | Experimental | CYC065 will be administered by 4 -hour infusion every 3 weeks. | |
| CYC065 - 1 hour infusion (Part 2 - ongoing) | Experimental | CYC065 will be administered by 1 - hour infusion on Days 1, 2, 8, and 9 every 3 weeks | |
| CYC065 - Oral (Part 3 - ongoing) | Experimental | CYC065 will be administered orally on Days 1, 2, 8 and 9 every 3 weeks | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of patients who experience dose-limiting toxicities |
| Time Frame: | cycle 1(each cycle is 21 -28 days) |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Plasma concentrations |
| Time Frame: | cycle 1(each cycle is 21 -28 days) |
| Safety Issue: | |
| Description: | |
| Measure: | Half-life of CYC065 |
| Time Frame: | cycle 1(each cycle is 21 -28 days) |
| Safety Issue: | |
| Description: | |
| Measure: | changes in certain protein levels in peripheral white blood cells by western blots |
| Time Frame: | cycle 1(each cycle is 21 -28 days) |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Cyclacel Pharmaceuticals, Inc. |
Last Updated
August 26, 2019
