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ClinicalTrial.gov Identifier : NCT00804908

A Study Evaluating Efficacy of ABT-888 in Combination With Temozolomide in Metastatic Melanoma

    Status Completed
    Related Conditions

Enrollment Details

346 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type II phase trial.

Protocol ID
M10-440

Brief summary

Top

The purpose of this study is to evaluate the efficacy of ABT-888 in combination with temozolomide versus temozolomide alone in subjects with metastatic melanoma.

Participant Attributes :
  • Male and Female
  • Ages 18 Years to 99 Years

Canada: 7

0
Calgary, AB
1
Edmonton, AB
2
Hamilton, ON
3
Montreal, QC
4
Toronto, ON
5
Montreal, QC
6
Montreal, QC
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Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
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    Allocation

    Randomized

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
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    Endpoint Classification

    Efficacy Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Parallel Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

    • 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.
    • 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.

More on this trial

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