Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT02065466
Brief Summary:
1.1. Primary Objectives
1\. To determine if nab-paclitaxel and temozolomide can be combined with full dose of bevacizumab for the therapy of patients with newly diagnosed brain metastases of metastatic malignant melanoma.
* To define the MTD of the combination (Phase I component).
* To determine progression free survival (Phase II component). 1.2. Secondary Objectives
1. To separately evaluate the response rate and duration of both the brain and extra-cranial systemic metastases.
2. To define the toxicity of the regimen.
3. To tabulate the toxicity of the radiotherapy to the brain and compare with known toxicities of radiotherapy to the brain in melanoma and brain metastases.
4. To use the data generated to plan definitive controlled clinical trials of the combination.
5. To determine the overall response rate (Phase II component).
Study:
NCT02065466
Study Brief:
Protocol Section:
NCT02065466