Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Leukemia and Lymphoma Society | OTHER |
| Therapeutics, Inc. | INDUSTRY |
| Veristat, Inc. | OTHER |
| PPD Development, LP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo for SHAPE (SHP-141) | Placebo Comparator | placebo for SHAPE (SHHP-141) topical gelled solution |
|
| SHAPE (SHP-141) 0.1%BID | Experimental | SHAPE (SHP-141) topical gelled solution at 0.1% concentration twice weekly |
|
| SHAPE (SHP-141) 0.5% BID | Experimental | SHAPE (SHP-141) topical gelled solution at 0.5% concentration twice weekly |
|
| SHAPE (SHP-141) 1.0% BID | Experimental | SHAPE (SHP-141) topical gelled solution at 1.0% concentration twice weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo for SHAPE (SHP-141) | Drug | topical gelled solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joan Guitart, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| Northwestern University Dept of Dermatology |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo for SHAPE (SHP-141) | placebo for SHAPE (SHP-141): topical gelled solution |
| FG001 | SHAPE (SHP-141) 0.1% BID | SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| INDUSTRY |
Not provided
Not provided
Not provided
Not provided
| SHAPE (SHP-141) 0.1% BID |
| Drug |
topical gelled solution |
|
| SHAPE (SHP-141) 0.5% BID | Drug | topical gelled solution |
|
| SHAPE (SHP-141) 1.0% BID | Drug | topical gelled solution |
|
| Chicago |
| Illinois |
| 60611 |
| United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Gahanna | Ohio | 43230 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| FG002 | SHAPE (SHP-141) 0.5% BID | SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily |
| FG003 | SHAPE (SHP-141) 1.0% BID | SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo for SHAPE (SHP-141) | placebo for SHAPE (SHP-141): topical gel |
| BG001 | SHAPE (SHP-141) 0.1% BID | SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily |
| BG002 | SHAPE (SHP-141) 0.5% BID | SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily |
| BG003 | SHAPE (SHP-141) 1.0% BID | SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of participants | Weekly through day 28 (days 1, 7, 14, 21, 28) and again day 42 |
|
|
|
42 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo for SHAPE (SHP-141) | placebo for SHAPE (SHP-141): topical gelled solution | 0 | 3 | 2 | 3 | ||
| EG001 | SHAPE (SHP-141) 0.1% BID | SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily | 0 | 5 | 5 | 5 | ||
| EG002 | SHAPE (SHP-141) 0.5% BID | SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily | 0 | 5 | 4 | 5 | ||
| EG003 | SHAPE (SHP-141) 1.0% BID | SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily | 0 | 5 | 4 | 5 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA 15 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| GGT increased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA 15 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15 | Systematic Assessment |
| |
| Incision site blister | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 15 | Systematic Assessment |
| |
| Applications site warmth | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 15 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 15 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 15 | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA 15 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 15 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Research | TetraLogic Pharmaceuticals | 610-889-9900 | jeffrey.skolnik@tetralogicpharma.com |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C494814 | BID protein, human |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|