Lymphoma, T-Cell, CutaneousPhase 1NCT01433731
Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL)
A Phase 1 study testing SHAPE (SHP-141) 0.1% BID, SHAPE (SHP-141) 0.5% BID and SHAPE (SHP-141) 1.0% BID in people with Lymphoma, T-Cell, Cutaneous, run by TetraLogic Pharmaceuticals at 6 sites in United States.
Trial summary
The purpose of this study is to investigate the safety and tolerability of topical SHP141 applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Cutaneous
- What is being tested?
- SHAPE (SHP-141) 0.1% BID, SHAPE (SHP-141) 0.5% BID and SHAPE (SHP-141) 1.0% BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2011to Sep 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically confirmed CTCL; a documented verifiable biopsy report is required.
- Documented clinical Stage IA, IB, or IIA CTCL.
- Skin lesion involvement of at least 3% of BSA accessible for topical application of study drug and biopsy.
- ECOG performance status of 0-2.
Who cannot join
- CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL.
- Severe pruritus requiring systemic or topical treatment.
- Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and has been designated as Stage IA-IIA disease).
- Coexistent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix (CIN 3), papillary or follicular thyroid cancer that has been treated curatively, or prostate cancer that has been treated curatively).
- Any prior history of a hematologic malignancy (other than CTCL).
- History of or current major renal, hepatic, gastrointestinal, pulmonary, cardiovascular, genito-urinary or hematological disease, CNS disorders, infectious disease or coagulation disorders as determined by the Investigator.
- Evidence of active Hepatitis B or C or HIV.
- Circulating atypical cells >5%
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Northwestern University Dept of Dermatology
Chicago, Illinois, 60611
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University
Gahanna, Ohio, 43230
MD Anderson Cancer Center
Houston, Texas, 77030
Stanford University
Stanford, California, 94305
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase 1b Study to Assess the Safety, Pharmacodynamics and Pharmacokinetics of SHP 141, A Histone Deacetylase Inhibitor, Administered Topically Up to 28 Days to Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma
The purpose of this study is to investigate the safety and tolerability of topical SHP141 applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL.
- Conditions
- Lymphoma, T-Cell, Cutaneous
- Being tested
- placebo for SHAPE (SHP-141), SHAPE (SHP-141) 0.1% BID, SHAPE (SHP-141) 0.5% BID, SHAPE (SHP-141) 1.0% BID
- Keywords
- CTCL, Cutaneous T-Cell Lymphoma
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo for SHAPE (SHP-141)Drug
topical gelled solution
SHAPE (SHP-141) 0.1% BIDDrug
topical gelled solution
SHAPE (SHP-141) 0.5% BIDDrug
topical gelled solution
SHAPE (SHP-141) 1.0% BIDDrug
topical gelled solution
| Study group | Role | What they receive |
|---|---|---|
| placebo for SHAPE (SHP-141) | Placebo comparator | placebo for SHAPE (SHHP-141) topical gelled solution Receives: Drug: placebo for SHAPE (SHP-141) |
| SHAPE (SHP-141) 0.1%BID | Experimental | SHAPE (SHP-141) topical gelled solution at 0.1% concentration twice weekly Receives: Drug: SHAPE (SHP-141) 0.1% BID |
| SHAPE (SHP-141) 0.5% BID | Experimental | SHAPE (SHP-141) topical gelled solution at 0.5% concentration twice weekly Receives: Drug: SHAPE (SHP-141) 0.5% BID |
| SHAPE (SHP-141) 1.0% BID | Experimental | SHAPE (SHP-141) topical gelled solution at 1.0% concentration twice weekly Receives: Drug: SHAPE (SHP-141) 1.0% BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity)
Response assessed by change in lesion severity using Composite Assessment of Index Lesion Severity (CAILS) Assessment Tool which measures clinical signs of CTCL by erythema; scaling; plaque elevation; hypo- or hyperpigmentation, each on a scale of 0-8; and lesion size (cm2), on a scale of 0 (no lesion; 0 cm2) to 18 (300 cm2). Up to five index lesions are each scored, and a subtotal CAILS score is provided for each index lesion. A total score is calculated by summing these subtotals. Response criteria measure the change in CAILS score from baseline to follow-up as follows: Complete Response (CR): 100% decrease in CAILS score; Partial Response (PR): 50% - 99% decrease in CAILS score; Stable Disease (SD): < 25% increase to < 50% decrease in CAILS score; Progressive Disease (PD) ≥ 25% increase in CAILS score.
Measured: Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lymphoma, T-Cell, CutaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- TetraLogic Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Leukemia and Lymphoma Society, Therapeutics, Inc., Veristat, Inc., PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Joan Guitart, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433731
- Sponsor's protocol ID
- SHP-141-001
- Status last verified
- Jan 2016
- First submitted
- 9 Sep 2011
- Last updated
- 24 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Phase 1b Study to Assess the Safety, Pharmacodynamics and Pharmacokinetics of SHP 141, A Histone Deacetylase Inhibitor, Administered Topically Up to 28 Days to Patients With Stage IA, IB or IIA Cutaneous T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01433731
- Acronym / sponsor ID
- SHP-141-001
- Conditions
- Lymphoma, T-Cell, Cutaneous
- Keywords
- CTCL, Cutaneous T-Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- TetraLogic PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- The Leukemia and Lymphoma Society, Therapeutics, Inc., Veristat, Inc., PPD Development, LP
- Study start
- Nov 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Posted 24 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety and tolerability of topical SHP141 applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo for SHAPE (SHP-141) | Placebo comparator | Drug: placebo for SHAPE (SHP-141)placebo for SHAPE (SHHP-141) topical gelled solution |
| SHAPE (SHP-141) 0.1%BID | Experimental | Drug: SHAPE (SHP-141) 0.1% BIDSHAPE (SHP-141) topical gelled solution at 0.1% concentration twice weekly |
| SHAPE (SHP-141) 0.5% BID | Experimental | Drug: SHAPE (SHP-141) 0.5% BIDSHAPE (SHP-141) topical gelled solution at 0.5% concentration twice weekly |
| SHAPE (SHP-141) 1.0% BID | Experimental | Drug: SHAPE (SHP-141) 1.0% BIDSHAPE (SHP-141) topical gelled solution at 1.0% concentration twice weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histopathologically confirmed CTCL; a documented verifiable biopsy report is required.
- Documented clinical Stage IA, IB, or IIA CTCL.
- Skin lesion involvement of at least 3% of BSA accessible for topical application of study drug and biopsy.
- ECOG performance status of 0-2.
Key exclusion criteria (8 listed)
- CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL.
- Severe pruritus requiring systemic or topical treatment.
- Palpable lymph node ≥1.5 cm in diameter (unless the lymph node has been biopsied and has been designated as Stage IA-IIA disease).
- Coexistent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix (CIN 3), papillary or follicular thyroid cancer that has been treated curatively, or prostate cancer that has been treated curatively).
- Any prior history of a hematologic malignancy (other than CTCL).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo for SHAPE (SHP-141)topical gelled solution | Drug | placebo for SHAPE (SHP-141) |
| SHAPE (SHP-141) 0.1% BIDtopical gelled solution | Drug | SHAPE (SHP-141) 0.1%BID |
| SHAPE (SHP-141) 0.5% BIDtopical gelled solution | Drug | SHAPE (SHP-141) 0.5% BID |
| SHAPE (SHP-141) 1.0% BIDtopical gelled solution | Drug | SHAPE (SHP-141) 1.0% BID |
Primary outcome
Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity)
Time frame: Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42
Response assessed by change in lesion severity using Composite Assessment of Index Lesion Severity (CAILS) Assessment Tool which measures clinical signs of CTCL by erythema; scaling; plaque elevation; hypo- or hyperpigmentation, each on a scale of 0-8; and lesion size (cm2), on a scale of 0 (no lesion; 0 cm2) to 18 (300 cm2). Up to five index lesions are each scored, and a subtotal CAILS score is provided for each index lesion. A total score is calculated by summing these subtotals. Response criteria measure the change in CAILS score from baseline to follow-up as follows: Complete Response (CR): 100% decrease in CAILS score; Partial Response (PR): 50% - 99% decrease in CAILS score; Stable Disease (SD): < 25% increase to < 50% decrease in CAILS score; Progressive Disease (PD) ≥ 25% increase in CAILS score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Guitart, MD principal investigator
Northwestern University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHAPE (SHP-141) 0.1% BID, SHAPE (SHP-141) 0.5% BID and SHAPE (SHP-141) 1.0% BID in people with Lymphoma, T-Cell, Cutaneous, run by TetraLogic Pharmaceuticals at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Complete or Partial Response as Measured by Change in Lesion Severity Using CAILS (Composite Assessment of Index Lesion Severity) (time frame: Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.