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

NCT ID: NCT00804908

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2016-01-31

Brief Summary

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.

Conditions

Melanoma; Metastatic Melanoma; Skin Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo for ABT-888 BID + TMZ QD

Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.

Group Type: PLACEBO_COMPARATOR

temozolomide

Intervention Type: DRUG

temozolomide capsule administered orally once daily for 5 days every 28 days

Placebo

Intervention Type: OTHER

Placebo for ABT-888 capsule administered orally twice daily for 7 days every 28 days

ABT-888 20 mg BID + TMZ QD

ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.

Group Type: ACTIVE_COMPARATOR

temozolomide

Intervention Type: DRUG

temozolomide capsule administered orally once daily for 5 days every 28 days

ABT-888

Intervention Type: DRUG

ABT-888 capsule administered orally twice daily for 7 days every 28 days

ABT-888 40 mg BID + TMZ QD

ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.

Group Type: ACTIVE_COMPARATOR

temozolomide

Intervention Type: DRUG

temozolomide capsule administered orally once daily for 5 days every 28 days

ABT-888

Intervention Type: DRUG

ABT-888 capsule administered orally twice daily for 7 days every 28 days

Interventions

temozolomide

temozolomide capsule administered orally once daily for 5 days every 28 days

Intervention Type: DRUG

ABT-888

ABT-888 capsule administered orally twice daily for 7 days every 28 days

Intervention Type: DRUG

Placebo

Placebo for ABT-888 capsule administered orally twice daily for 7 days every 28 days

Intervention Type: OTHER

Other Intervention Names

Temodar; Temodal; veliparib

Eligibility Criteria

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 international normalized ratio (INR) < 1.5.
• Subject's with significant fluid retention may be allowed at the discretion of the investigator.
• 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 central nervous system metastases or leptomeningeal disease.
• Prior treatment with Dacarbazine (DTIC) or Temozolomide (TMZ).
• Prior DNA damaging agents or cytotoxic chemotherapy.
• Prior Whole Brain Radiation Therapy (with exceptions).
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc

Role: STUDY_DIRECTOR

AbbVie

References

Middleton MR, Friedlander P, Hamid O, Daud A, Plummer R, Falotico N, Chyla B, Jiang F, McKeegan E, Mostafa NM, Zhu M, Qian J, McKee M, Luo Y, Giranda VL, McArthur GA. Randomized phase II study evaluating veliparib (ABT-888) with temozolomide in patients with metastatic melanoma. Ann Oncol. 2015 Oct;26(10):2173-9. doi: 10.1093/annonc/mdv308. Epub 2015 Jul 22.

Reference Type: RESULT

PMID: 26202595 (View on PubMed)

Other Identifiers

2008-004941-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M10-440

Identifier Type: -

Identifier Source: org_study_id