TriangleNCT00091559 · CITED IN SOURCE DOCUMENTS
Oral SAHA (Suberoylanilide Hydroxamic Acid) in Advanced Cutaneous T-cell Lymphoma (0683-001)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2017-04-05
A study for patients diagnosed with advanced cutaneous T-cell lymphoma (stage 1B or higher) who have progressive, persistent, or recurrent disease on or following 2 other therapies, one of which must have contained Targretin (bexarotene)or for patients who are not candidates or could not tolerate Targretin therapy.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Patients with Cutaneous T-cell Lymphoma (Stage 1B or higher) * Age: over 18 years of age * Have the ability to swallow capsules. * You must be at least 3 weeks from any prior chemotherapy or anticancer therapy treatment and have recovered from any side effects of that treatment. * Patients also require adequate heart, liver, and kidney function. Exclusion Criteria: * Pregnant and nursing women and those with known allergy to the study drug are excluded from this study. * Patients are excluded if they are currently receiving chemotherapy, radiation therapy, or other investigational anti-cancer therapy. * Patients diagnosed with HIV, active hepatitis or who require intravenous antibiotics or antifungal agents are not permitted.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- interventions
- name
- MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months
- type
- DRUG
Study design
- allocation
- NON_RANDOMIZED
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 74
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Objective response rate in patients with progressive, persistent, or recurrent disease.
- secondary Outcomes
- measure
- Response duration, relief of pruritis, time to progression, time to objective response, safety & tolerability in this population.
Full study description
- brief Summary
- A study for patients diagnosed with advanced cutaneous T-cell lymphoma (stage 1B or higher) who have progressive, persistent, or recurrent disease on or following 2 other therapies, one of which must have contained Targretin (bexarotene)or for patients who are not candidates or could not tolerate Targretin therapy.
Source references
- avail Ipds
- type
- CSR Snyopsis Links
- references
- citation
- Olsen EA, Kim YH, Kuzel TM, Pacheco TR, Foss FM, Parker S, Frankel SR, Chen C, Ricker JL, Arduino JM, Duvic M. Phase IIb multicenter trial of vorinostat in patients with persistent, progressive, or treatment refractory cutaneous T-cell lymphoma. J Clin Oncol. 2007 Jul 20;25(21):3109-15. doi: 10.1200/JCO.2006.10.2434. Epub 2007 Jun 18.
- pmid
- 17577020
- type
- BACKGROUND
- citation
- Fantin VR, Loboda A, Paweletz CP, Hendrickson RC, Pierce JW, Roth JA, Li L, Gooden F, Korenchuk S, Hou XS, Harrington EA, Randolph S, Reilly JF, Ware CM, Kadin ME, Frankel SR, Richon VM. Constitutive activation of signal transducers and activators of transcription predicts vorinostat resistance in cutaneous T-cell lymphoma. Cancer Res. 2008 May 15;68(10):3785-94. doi: 10.1158/0008-5472.CAN-07-6091.
- pmid
- 18483262
- type
- BACKGROUND
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-ce39805ba4bfb8dffe2e
- requested nct id
- NCT00091559
- primary nct id
- NCT00091559
- source kind
- fda_spl_label
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- payload
- application numbers
- NDA021991
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-ce39805ba4bfb8dffe2e
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT00091559
- occurrences
- context exact
- both studies, patients were treated until disease progression or intolerable toxicity. Study 1 In an open-label, single-arm, multicenter non-randomized study (NCT00091559), 74 patients with advanced CTCL were treated with ZOLINZA at a dose of 400 mg once daily. The primary endpoint was response rate to oral ZOLINZA in the treatm
- end
- 445
- exact text
- NCT00091559
- start
- 434
- offset unit
- unicode_code_points
- source file
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- source file sha256
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- source json pointer
- /results/40/clinical_studies/0
- source kind
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- source string sha256
- c94934ab3fc38a9df19ab12c2371eafd3afb7263ef70b1a8a1590d5c745f3226
- spl effective time
- 20241112
- spl set id
- cd86ee78-2781-468b-930c-3c4677bcc092
Preserved source evidence · Not medical advice