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A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy of ABT-888 in Combination With Temozolomide Versus Temozolomide Alone in Subjects With Metastatic Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma, Metastatic Melanoma, Skin Cancer

Thank you

Trial Information

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating the Efficacy of ABT-888 in Combination With Temozolomide Versus Temozolomide Alone in Subjects With Metastatic Melanoma


Inclusion Criteria:



- Histologically (or cytologically) confirmed metastatic melanoma.

- Unresectable Stage III or Stage IV metastatic melanoma.

- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

- Subjects with no history of brain metastases demonstrated by a baseline MRI,or
subjects with a history of previously treated brain metastases who have history of
operable/SRS treatable brain metastases and completed surgical resection/stereotactic
radiosurgery with or without adjuvant whole brain radiation at least 28 days prior to
Day 1.

- have baseline MRI that shows no evidence of active intercranial disease

- have discontinued taking medications for symptom management of brain metastases at
least 7 days prior to Day 1

- 28 days since prior anti-cancer therapy.

- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.

- Adequate hematologic, renal and hepatic function.

- Partial Thromboplastin Time (PTT) is <= 1.5 x upper normal limit of institution's
normal range and INR < 1.5.

- Subject's with significant fluid retention may be allowed at the discretion of the
PI.

- Life expectancy > 12 weeks.

- Females must not be pregnant.

- Voluntarily signed informed consent.

Exclusion Criteria:

- Lactate Dehydrogenase (LDH) > 2 x Upper Limit of Normal (ULN).

- Ocular malignant melanoma.

- History of CNS metastases or leptomeningeal disease.

- Prior treatment with Dacarbazine (DTIC) or Temozolomide (TMZ).

- Prior DNA damaging agents or cytotoxic chemotherapy.

- Prior Whole Brain Radiation Therapy.

- Received an investigational agent within 28 days of study.

- History of seizure disorder and/or taking medication for seizure disorder.

- Active malignancy within the past 5 years, except cervical cancer in situ, in situ
carcinoma of the bladder or non-melanoma carcinoma of the skin.

- Medical condition that would cause a high risk for toxicities.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival

Outcome Time Frame:

Radiographic evaluation every 2 months, clinical evaluation monthly

Safety Issue:

No

Principal Investigator

Mark McKee, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

United States: Food and Drug Administration

Study ID:

M10-440

NCT ID:

NCT00804908

Start Date:

February 2009

Completion Date:

September 2013

Related Keywords:

  • Melanoma
  • Metastatic Melanoma
  • Skin Cancer
  • ABT-888
  • Skin cancer
  • MM
  • Temozolomide
  • Melanoma
  • Metastatic Melanoma
  • Skin Neoplasms
  • Melanoma

Name

Location

Site Reference ID/Investigator# 18801 Birmingham, Alabama  35243
Site Reference ID/Investigator# 14609 La Jolla, California  92093-0820
Site Reference ID/Investigator# 14612 Los Angeles, California  90025
Site Reference ID/Investigator# 14618 San Francisco, California  94115
Site Reference ID/Investigator# 13861 San Francisco, California  94115
Site Reference ID/Investigator# 14615 Aurora, Colorado  80045
Site Reference ID/Investigator# 14623 Lakeland, Florida  33805
Site Reference ID/Investigator# 13822 Orlando, Florida  32806
Site Reference ID/Investigator# 13862 Park Ridge, Illinois  60068
Site Reference ID/Investigator# 20963 Indianapolis, Indiana  46202
Site Reference ID/Investigator# 14631 Baltimore, Maryland  21237
Site Reference ID/Investigator# 14626 Lutherville, Maryland  21093
Site Reference ID/Investigator# 14610 Boston, Massachusetts  02215
Site Reference ID/Investigator# 21462 Boston, Massachusetts  02215
Site Reference ID/Investigator# 21461 Boston, Massachusetts  02215
Site Reference ID/Investigator# 14616 St. Louis, Missouri  63110
Site Reference ID/Investigator# 13682 Lebanon, New Hampshire  03756-0001
Site Reference ID/Investigator# 14632 Morristown, New Jersey  07962
Site Reference ID/Investigator# 14633 Buffalo, New York  14263
Site Reference ID/Investigator# 14620 New York, New York  10016
Site Reference ID/Investigator# 14602 Charlotte, North Carolina  28204
Site Reference ID/Investigator# 14628 Cleveland, Ohio  44195
Site Reference ID/Investigator# 20965 Columbus, Ohio  43219
Site Reference ID/Investigator# 14625 Philadelphia, Pennsylvania  19107
Site Reference ID/Investigator# 14622 Nashville, Tennessee  37232-6307
Site Reference ID/Investigator# 14606 Houston, Texas  77024
Site Reference ID/Investigator# 21901 Houston, Texas  77030
Site Reference ID/Investigator# 14603 Madison, Wisconsin  53792