Clinical Research Details
Title:
A Randomized, Double-blind, Placebo-controlled, Phase Two Study Evaluating the Efficacy of ABT-888 in Combination With Temozolomide Versus Temozolomide Alone in Subjects With Metastatic Melanoma.
Purpose:
The primary objective of the study is to assess if the addition of ABT-888 to temozolomide (TMZ) can prolong PFS compared to TMZ alone in subjects with metastatic melanoma (MM).
The secondary objectives of the study will be to determine overall survival, one-year survival rate, six-month progression-free survival rate, response rate, disease control rate, duration of overall response, quality of life, safety and tolerability and time to neurological/brain progression.
Study Number:
202150091609
Number of Patients:
300
Elgibility:
1. Subject must be = 18 years of age.
2. Histologically (or cytologically) confirmed metastatic melanoma
3. Unresectable Stage III or Stage IV metastatic melanoma
4. Subject has measurable disease, defined as at least one unidimensionally measurable lesion on a CT scan as defined by RECIST.
5. Subjects with no history of brain metastases as demonstrated by a baseline MRI that shows no evidence of intercranial disease, or subjects with a history of previously treated brain metastases who:
• Have a history of operable/SRS treatable brain metastases and have completed any surgical resection/stereotactic radiosurgery with or without adjuvant whole brain radiation at least 28 days prior to Day 1;
• Have a baseline MRI that shows no evidence of active intercranial disease and have discontinued taking any medications for symptom management of brain metastases (e.g., steroids) at least seven days prior to Day 1;
• Have a baseline MRI that shows no evidence of active intercranial disease and have discontinued taking any medications for symptom management of brain metastases (e.g., steroids) at least seven days prior to Day 1.
Treatment:
If you decide to be in this study, you will be randomized to one of three treatment groups. This means you will be assigned by chance (similar to a flip of a coin) to receive one of the following treatments: • A combination of temozolomide and 20 mg twice-a-day of ABT-888 • A combination of temozolomide and 40 mg twice-a-day of ABT-888 • A combination of temozolomide and a twice-a-day placebo (a pill that does not contain any active drug).
You will receive the same treatment for the entire study. About one-third of the patients will receive 20 mg twice a day of ABT-888, one third of the patients will receive 40 mg twice a day of ABT-888 and one third will receive a placebo. The study is double-blinded, which means you and your doctor will not know if you are taking ABT-888 or placebo. However, the study doctor can find this information out in case of an emergency.
You will take temozolomide orally (by mouth) once a day in the morning under fasting conditions (no food or drink for two hours prior to taking your study medication to reduce the chance of nausea and vomiting) for five days in a row followed by 23 days off temozolomide. Your doctor will tell you how many capsules you must take each time.
You will take ABT-888 or a placebo orally (by mouth) twice a day. One dose of ABT-888 or a placebo will be taken in the morning with the temozolomide under fasting and one dose approximately 12 hours later (no fasting required) for seven days in a row followed by 21 days off ABT-888 or a placebo. Your doctor will tell you how many capsules you must take each time.
Principal Investigator:
Enrollment Phone:
(708) 327-3221