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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Randomization to date of death from any cause, (assessed at every cycle and every 60 days following treatment discontinuation)

Safety Issue:

Yes

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

13101

NCT ID:

NCT01006252

Start Date:

December 2009

Completion Date:

March 2011

Related Keywords:

  • Melanoma
  • metastatic
  • second-line
  • Melanoma

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Iowa City, Iowa  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Durham, North Carolina  
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Birmingham, Alabama  35294
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Phoenix, Arizona  85012
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Greenbrae, California  94904
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Minneapolis, Minnesota  55404
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.St Joseph, Missouri  64507
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Cincinnati, Ohio  45267
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Dunmore, Pennsylvania  18512
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