Clinical TrialID 7242
Gamma-secretase/Notch Signalling Pathway Inhibitor RO4929097 in Combination With Cisplatin, Vinblastine, and Temozolomide in Treating Patients With Recurrent or Metastatic Melanoma
NCT01196416
Recurrent Melanoma|Stage IV Skin Melanoma
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7242
- Evidence Id
- 7242
- Core Evidence Id
- 7242
- Source Clinical Trial Id
- 7232
- Herb2 Clinical Trial Id
- HBCT007232
- Nct Id
- NCT01196416
- Title
- Gamma-secretase/Notch Signalling Pathway Inhibitor RO4929097 in Combination With Cisplatin, Vinblastine, and Temozolomide in Treating Patients With Recurrent or Metastatic Melanoma
- Status
- Completed
- Phase
- Phase 1|Phase 2
- Study Result
- Yes
- Study Condition
- Recurrent Melanoma|Stage IV Skin Melanoma
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Cisplatin|DRUG: Gamma-Secretase Inhibitor RO4929097|OTHER: Laboratory Biomarker Analysis|OTHER: Pharmacological Study|DRUG: Temozolomide|DRUG: Vinblastine Sulfate
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 14
- Outcome Measure
- Overall Objective Response, Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years|Maximum-tolerated Dose for Cisplatin, Vinblastine and TMZ, based on the incidence of dose-limiting toxicity as assessed the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase IB) Data is not yet available, as it's currently being analyzed., 21 days|Overall Survival (Phase II), Overall response rate (complete \[CR\] or partial response \[PR\]) according to RECIST version 1.1, Up to 2 years|Maximum Tolerated Dose for RO4929097, based on the incidence of dose-limiting toxicity as assessed the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase IB), 21 days
- Sponsor Collaborator
- National Cancer Institute (NCI)
- Funded By
- NIH
- Location
- Memorial Sloan-Kettering Cancer Center, New York, New York, 10065, United States
- Other Id
- NCI-2011-02524|NCI-2011-02524|CDR0000684220|10-085|8491|N01CM62206|P30CA008748|U01CA069856
- Start Date
- 2010-08
- Primary Completion Date
- 2015-08
- Completion Date
- 2015-08
- First Posted
- 2010-09-08
- Results First Posted
- 2017-10-18
- Last Update Posted
- 2019-11-18
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01196416
- Title Cn
- Title En
- Gamma-secretase/Notch Signalling Pathway Inhibitor RO4929097 in Combination With Cisplatin, Vinblastine, and Temozolomide in Treating Patients With Recurrent or Metastatic Melanoma
- Bilingual Status
- semi_complete