Conditions

Metastatic Melanoma

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Achieving Objective Response Rate (ORR) (Complete Response + Partial Response)
Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date.
Baseline to Measured Progressive Disease (up to 60 Months)

Secondary Outcomes (8)

Progression-Free Survival (PFS)
Baseline to Measured Progressive Disease or Death from Any Cause (up to 42 Months)
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Response Rate)
Baseline to Progressive Disease or Death Due to Any Cause (up to 60 Months)
Pharmacokinetics: Plasma Clearance Rate of Tasisulam
Cycle 1-3, Day 1, 8 and 15: Predose, End of Infusion, and Postinfusion
Overall Survival (OS) Time
Baseline to Death from Any Cause (up to 42 Months)
Duration of Overall Objective Response
Date of Response to Date of Measured PD (up to 1 Year)
+3 more secondary outcomes

Study Arms (1)

Tasisulam

EXPERIMENTAL

Drug: tasisulam

Interventions

tasisulamDRUG

Tasisulam dose is dependent on participant's height, weight, and gender and is adjusted to target a specific Cmax based on participant laboratory parameters. Tasisulam is administered intravenously every 28 days until disease progression or other criteria for participant discontinuation are met.

Also known as: LY573636

Tasisulam

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.