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

NOT ENROLLING
Protocol # :
15-281
Conditions
Cancer
Phase
I
Disease Sites
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Other Endocrine System
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Multiple Myeloma
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Shapiro, Geoffrey, I.
Site Research Nurses
Amweg, Laura, N.
Anderson, Adrienne
Baylies, Rosemarie
Beardslee, Brian
Bell, Tracy
Caramella, Anne
Caramella, Anne
Carey, Margaret, M.
Carrier, Amy
DeGonge, Danielle
Gillen Mckay, Christine, A.
Grimes, Hayley
Harran, John
Hart, Kayla
Hassinger, Faith
Hassinger, Faith
Hedglin, Jennifer
Hewes, Julia
Mackoul, Anna
McCarthy, Elizabeth, Ann
Morse, Linda, K.
O’Neill, Kailene
Patchel, Rachel, Alexandra
Powers, Allison
QUINN, NICHOLAS
Rang, Bethany
Rowan, Jennifer, M.
Sze, Cameron

Trial Description

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

Eligibility Requirements

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

15-281