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

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

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

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

Conditions
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Cancer

Intervention / Treatment
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* Drug: CYC065


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CYC065 - 4 hour infusion (Part 1 completed)<br>CYC065 will be administered by 4 -hour infusion every 3 weeks. | Drug: CYC065<br> <br> |
| Experimental: CYC065 - 1 hour infusion (Part 2 - ongoing)<br>CYC065 will be administered by 1 - hour infusion on Days 1, 2, 8, and 9 every 3 weeks | Drug: CYC065<br> <br> |
| Experimental: CYC065 - Oral (Part 3 - ongoing)<br>CYC065 will be administered orally on Days 1, 2, 8 and 9 every 3 weeks | Drug: CYC065<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who experience dose-limiting toxicities |  | cycle 1(each cycle is 21 -28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations |  | cycle 1(each cycle is 21 -28 days) | 
| Half-life of CYC065 |  | cycle 1(each cycle is 21 -28 days) | 
| changes in certain protein levels in peripheral white blood cells by western blots |  | cycle 1(each cycle is 21 -28 days) |