Phase 2
Completed N=130
A Study of Tasisulam in Treating Participants With Malignant Melanoma
Source: ClinicalTrials.gov NCT00383292 ↗Enrolled (actual)
130
Serious AEs
36.9%
Results posted
Jun 2018
Primary outcomePrimary: Percentage of Participants Achieving Objective Response Rate (ORR) (Complete Response + Partial Response) — 10; 6; 7 Percentage of Participants
Summary
The primary purpose of this study is to determine the objective response rate (complete and partial response) for participants who receive tasisulam after one prior systemic treatment for unresectable or metastatic melanoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Objective Response Rate (ORR) (Complete Response + Partial Response) |
10; 6; 7 | — |
| SECONDARY Progression-Free Survival (PFS) |
2.8; 2.8; 3.5 | — |
| SECONDARY Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Response Rate) |
47; 47; 50 | — |
| SECONDARY Pharmacokinetics: Plasma Clearance Rate of Tasisulam |
0.0275 | — |
| SECONDARY Overall Survival (OS) Time |
10.5; 11.9; 20.1 | — |
| SECONDARY Duration of Overall Objective Response |
5.6; 7.2; 4.1 | — |
| SECONDARY Duration of Stable Disease (SD) |
6.9; 6.4; 5.7 | — |
| SECONDARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (Safety: Adverse Events) |
13; 6; 6 | — |
| SECONDARY Health-Related Quality of Life: Functional Assessment of Cancer Therapy-General (FACT-G) Score |
80.76 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of malignant melanoma that is unresectable or metastatic (Stage III or IV)
- Have received 1 previous systemic treatment regimen for unresectable or metastatic melanoma. An immunotherapy or antibody-based regimen (including vaccination-based treatments) is not counted as a prior treatment regimen for determining study eligibility, unless it was combined with a chemotherapeutic or targeted anti-cancer drug.
- Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days
Exclusion Criteria
- Serious pre-existing medical conditions
- Have received two or more previous treatment regimens for unresectable or metastatic melanoma
- Have a second primary cancer (unless disease-free to more than 2 years)
- Active treatment with Warfarin (Coumadin)
- Primary ocular or mucosal melanoma
Data sourced from ClinicalTrials.gov (NCT00383292). 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. Informational only — not medical advice.