A Study of Tasisulam Versus Paclitaxel as Treatment for Metastatic Melanoma - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01006252

Purpose

The primary purpose of this study is to see how tasisulam affects metastatic melanoma when compared against paclitaxel as measured by overall survival.

Condition	Intervention	Phase
Melanoma	Drug: Tasisulam Drug: Paclitaxel	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Phase 3 Study of Tasisulam Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle vs. Paclitaxel as Second-Line Treatment in Patients With Metastatic Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Overall survival [ Time Frame: Randomization to date of death from any cause, (assessed at every cycle and every 60 days following treatment discontinuation) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Progression free survival [ Time Frame: Randomization to date of objectively determined progressive disease or death from any cause, (assessed at every cycle and every 60 days following treatment discontinuation) ] [ Designated as safety issue: No ]
Proportion of randomized patients having a confirmed best response of Partial Response (PR) or Complete Response (CR) [ Time Frame: First date that that RECIST criteria are met for CR or PR (whichever status occurs first) until the first date of documented progressive disease or death due to any cause, (assessed every other cycle) ] [ Designated as safety issue: No ]
Duration of response for patients having an objective response of Partial response (PR) and Complete Response(CR) [ Time Frame: First date that that RECIST criteria are met for CR or PR (whichever status occurs first) until the first date of documented progressive disease or death due to any cause, (assessed every other cycle) ] [ Designated as safety issue: No ]
Proportion of randomized patients having a confirmed best overall response of Partial Response (PR) or Complete Response (CR) plus patients with an overall response of Stable Disease (SD) [ Time Frame: First date that that RECIST criteria are met for CR, PR, or SD until the first date of documented progressive disease or death due to any cause, (assessed every other cycle) ] [ Designated as safety issue: Yes ]
Time to deterioration in the Functional Assessment of Cancer Therapy- Melanoma trial outcome index score (FACT-M TOI) [ Time Frame: Randomization to the first date of deterioration in the (FACT-M TOI) or of death from any cause, (assessed every cycle and up to 30 days following treatment discontinuation) ] [ Designated as safety issue: Yes ]
Change in Functional Assessment of Cancer Therapy - Melanoma (FACT-M) from baseline to 30 days following treatment discontinuation [ Time Frame: Baseline to every cycle, and up to 30 days following treatment discontinuation ] [ Designated as safety issue: Yes ]
Change in EuroQol-5 Dimensions (EQ-5D) from baseline to 30 days following treatment discontinuation [ Time Frame: Baseline to every cycle, and up to 30 days following treatment discontinuation ] [ Designated as safety issue: Yes ]
Pharmacokinetics Cmax [ Time Frame: Cycle 1 (day 1, 8, & 15), Cycle 2 (day 1), Cycle 3 (day 1) ] [ Designated as safety issue: No ]

Enrollment:	323
Study Start Date:	December 2009
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tasisulam	Drug: Tasisulam Individualized dose dependent on patient's height, weight, and gender and is adjusted to target a specific exposure based on a patient's laboratory parameters, administered intravenously on day 1 of 28 day cycle, until disease progression. Other Name: LY573636
Active Comparator: Paclitaxel	Drug: Paclitaxel 80 mg/m2 administered intravenously on days 1, 8, and 15 of 28 day cycle, until disease progression

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have a histologic and/or cytologic diagnosis of metastatic melanoma (Stage IV)
Have the presence of evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0)
Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group(ECOG) Scale
Have progressed after 1 previous systemic treatment containing dacarbazine or temozolomide for metastatic melanoma
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days (6 weeks for mitomycin-C or nitrosoureas) before study enrollment and recovered from the acute effects of therapy (except alopecia)
Have a serum albumin level greater than or equal to 3.0 g/dL or greater than or equal to 30 g/L

Exclusion Criteria:

Have received greater than or equal to 2 previous chemotherapy-containing systemic treatment regimens for metastatic melanoma. An immunotherapy or antibody-based regimen [including biologic agents and vaccination-based treatments], or treatment with a targeted agent (e.g BRAF or c-Kit inhibitor, is not counted as a prior treatment regimen for determining study eligibility, unless either was combined with a cytotoxic drug).
Have active central nervous system (CNS) or leptomeningeal metastasis (brain metastasis) at the time of study entry. Patients with signs or symptoms of neurological compromise should have appropriate radiographic imaging performed before study entry to rule out occult brain metastasis. Patients with a history of a solitary CNS metastasis previously treated with curative intent (e.g., stereotactic radiation or surgery) and not requiring steroids are eligible.
Are receiving warfarin
Have primary ocular or mucosal melanoma
Any previous treatment with paclitaxel or a paclitaxel-containing regimen for metastatic melanoma
Have serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator)
Have previously completed or withdrawn from this study or any other study investigating tasisulam
Have a known hypersensitivity to paclitaxel or Cremophor EL (polyoxyethylated castor oil)
Are pregnant or lactating
Have received a recent (within 30 days before enrollment) or are receiving concurrent yellow fever vaccination
Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb)
Are unable to withhold dosing of non-steroidal anti-inflammatory drugs (NSAIDs) or proton-pump inhibitors (PPIs) for at least 72 hours before and after treatment with tasisulam.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006252

Show 122 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT01006252 History of Changes
Other Study ID Numbers:	13101, H8K-MC-JZAO
Study First Received:	October 30, 2009
Last Updated:	August 9, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

metastatic
second-line

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Paclitaxel

Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012