A Study of Tasisulam Versus Paclitaxel as Treatment for Metastatic Melanoma (SUMMIT-1)

This study has been terminated.
(More possibly-related deaths on tasisulam arm; failed to pass futility hurdle)
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01006252
First received: October 30, 2009
Last updated: August 9, 2011
Last verified: March 2011
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014