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



Status:Completed
Conditions:Skin Cancer, Skin Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:February 2009
End Date:January 2016

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
25
sites
1654
mi
from 91732
Madison, WI
Click here to add this to my saved trials
825
mi
from 91732
Aurora, CO
Click here to add this to my saved trials
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
7198
mi
from 91732
Brisbane,
Click here to add this to my saved trials
2180
mi
from 91732
Buffalo, NY
Click here to add this to my saved trials
Charlotte, North Carolina 28207
2102
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
2032
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
1959
mi
from 91732
Columbus, OH
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
1793
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
99
mi
from 91732
La Jolla, CA
Click here to add this to my saved trials
2162
mi
from 91732
Lakeland, FL
Click here to add this to my saved trials
2515
mi
from 91732
Lebanon, NH
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from 91732
Lutherville, MD
Click here to add this to my saved trials
2407
mi
from 91732
Morristown, NJ
Click here to add this to my saved trials
1763
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
2182
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
1720
mi
from 91732
Park Ridge, IL
Click here to add this to my saved trials
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
355
mi
from 91732
San Francisco, CA
Click here to add this to my saved trials
1572
mi
from 91732
St. Louis, MO
Click here to add this to my saved trials