Clinical trial · Interventional
A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers
A Phase I Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers
NCT02552953CI-TRIAL-00077637completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, single arm, dose escalation study in patients with advanced cancers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CYC065 | Drug | Fadraciclib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- CYC065 - 4 hour infusion (Part 1 completed)
- description
- CYC065 will be administered by 4 -hour infusion every 3 weeks.
- interventionNames
- Drug: CYC065
- type
- EXPERIMENTAL
- label
- CYC065 - 1 hour infusion (Part 2 - ongoing)
- description
- CYC065 will be administered by 1 - hour infusion on Days 1, 2, 8, and 9 every 3 weeks
- interventionNames
- Drug: CYC065
- type
- EXPERIMENTAL
- label
- CYC065 - Oral (Part 3 - ongoing)
- description
- CYC065 will be administered orally on Days 1, 2, 8 and 9 every 3 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.