Phase 1
N=10
Vorinostat (MK-0683) Phase I Study in Cutaneous T-Cell Lymphoma (CTCL) Patients (MK-0683-089 EXT1)
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00771472 ↗Enrolled (actual)
10
Serious AEs
30.0%
Results posted
Jul 2012
Primary outcome: Primary: Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE) — 10; 6 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- vorinostat (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE) |
10; 6 | — |
| PRIMARY Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT) |
1 | — |
| SECONDARY Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours]) |
4.59; 5.59 | — |
| SECONDARY Part I: Maximum Drug Concentration (Cmax) |
0.83; 1.17 | — |
| SECONDARY Part I: Time at Which Cmax Occurs (Tmax) |
2.91; 3.73 | — |
| SECONDARY Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2) |
1.94; 2.30 | — |
Summary
Part I evaluates the safety, tolerability and pharmacokinetics (PK) of vorinostat in Japanese patients with relapsed or refractory CTCL. Part II evaluates the safety of vorinostat in Japanese pts. with relapsed or refractory CTCL. Relapsed or refractory CTCL patients will be newly enrolled in Part II.
Eligibility Criteria
Inclusion Criteria (Parts I & II):
- Patients With CTCL Who Have Progressive, Persistent Or Recurrent Disease Subsequent To At Least One Prior Therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status Must Be 0-2
- Patients Have Adequate Bone Marrow, Liver Function And Renal Function
Exclusion Criteria (Parts I & II):
- Patients Had Prior Therapy Within 3 Weeks Before Registration, Or Have Not Recovered From Toxicities Of Prior Therapy
- Patients Have Uncontrolled Intercurrent Illness
- Pregnant Or Women Have A Will To Be Pregnant And Lactating Woman
Data sourced from ClinicalTrials.gov (NCT00771472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.