Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Cc-486

Tubulin Modulators

Antimitotic Agents

Abraxane 150- mg/m² IV on Days 1, 8, and 15 of a 28-day cycle

Abraxane

Abraxane 150 mg/m\^2 intravenously on Days 1, 8, and 15 of a 28-day cycle

Kirsten Hege, MD

A phase 2, open-label randomized, multicenter trial to compare CC-486 in combination with Abraxane administered weekly with respect to overall survival, objective tumor response rate and Progression-Free Survival (PFS) in participants diagnosed with metastatic malignant melanoma.

The study will consist of the following phases:

* Screening (Baseline) Assessments: Performed within 21 days of randomization.
* Randomization: Subjects will be randomized within 21 days of starting their Baseline assessments.
* Treatment: Therapy may continue in the absence of clinically significant disease progression and unacceptable toxicity.
* Response Assessments: Subjects will be evaluated by investigators for CR, PR, stable or progressive disease every 6 weeks from the start of treatment until progressive disease is documented.

Responders and subjects with stable disease (SD) should continue on study unless they develop unacceptable toxicity, they start a new anticancer therapy, withdrawal of consent, physician decision or death.

* End of Study (EOS)/Treatment Evaluation: At the time subjects are removed from study, laboratory and clinical evaluations will be performed.
* Follow-up for Disease Progression:

  - Subjects who stop treatment prior to developing disease progression should be followed without further treatment until progressive disease is documented or until the treating physician feels additional treatment is required.
* Follow-up for Survival:

  * Post study, subject survival status will be monitored on a monthly basis for 6 months from discontinuation from the study and every 3 months thereafter, until death or study termination in all subjects.

Study to Determine Efficacy and Safety of CC-486 With Nab-Paclitaxel Versus Nab-Paclitaxel in Patients With Chemotherapy naïve Metastatic Melanoma

A Randomized, Open Label, Multi-center Phase 2 Study of Nab-Paclitaxel Versus Epigenetic Modifying Therapy of CC-4386 With Nab-Paclitaxel in Subjects With Chemotherapy naïve Metastatic Melanoma

PFS is defined as the time from randomization date to disease progression according to RECIST response guideline

OS is defined as the time from the date of randomization to the date of death.

PFS based on investigator assessment; PFS is defined as the time from randomization date to disease progression according to RECIST response guideline

Number (%) of subject who achieve an objective complete or partial response.

Number (%) of subject with Stable Disease (SD) ≥ for 18 weeks or complete or partial response.

Incidence and severity of Adverse events (AE) will be analyzed in terms of treatment-emergent AEs defined to be any AE that begin or worsen in severity after study drug initiation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study to Determine Efficacy and Safety of CC-486 With Nab-Paclitaxel Versus Nab-Paclitaxel in Patients With Chemotherapy naïve Metastatic Melanoma	NCT01933061	Metastatic Mela...	Abraxane Abraxane	18 Years -	Celgene
Study to Determine Efficacy and Safety of CC-486 With Nab-Paclitaxel Versus Nab-Paclitaxel in Patients With Chemotherapy naïve Metastatic Melanoma	NCT01933061	Metastatic Mela...	Abraxane Abraxane	18 Years -	Celgene

Spots Global Cancer Trial Database for skin cancer, melanoma