Trial · NCT01196416
Gamma-secretase/Notch Signalling Pathway Inhibitor RO4929097 in Combination With Cisplatin, Vinblastine, and Temozolomide in Treating Patients With Recurrent or Metastatic Melanoma
NCT01196416, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-10-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Gamma-secretase/Notch Signalling Pathway Inhibitor RO4929097 in Combination With Cisplatin, Vinblastine, and Temozolomide in Treating Patients With Recurrent or Metastatic Melanoma. Trials, record NCT01196416. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01196416
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gamma-secretase/Notch Signalling Pathway Inhibitor RO4929097 in Combination With Cisplatin, Vinblastine, and Temozolomide in Treating Patients With Recurrent or Metastatic Melanoma
- NCT number
- NCT01196416
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Recurrent Melanoma, Stage IV Skin Melanoma
- Interventions
- Cisplatin, Gamma-Secretase Inhibitor RO4929097, Laboratory Biomarker Analysis, Pharmacological Study, Temozolomide, Vinblastine Sulfate
- First posted
- 2010-09-08
- Last updated
- 2019-11-18
- Results first posted
- 2017-10-18
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Objective Response | 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 | 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 |
| Primary | Maximum-tolerated Dose for Cisplatin, Vinblastine and TMZ | 21 days | 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. |
| Primary | Overall Survival (Phase II) | Up to 2 years | Overall response rate (complete \[CR\] or partial response \[PR\]) according to RECIST version 1.1 |
| Primary | Maximum Tolerated Dose for RO4929097 | 21 days | 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) |
| Secondary | Participants' Change in Protein Levels | Baseline up to 2 weeks | Participants' pre and post-treatment protein levels will be compared |
| Secondary | Cycle 1 AUC/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB) | Days 4 and 5 | |
| Secondary | Cycle 1 C Max/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB) | At Cycle 1 | |
| Secondary | Cycle 1 Mean Day 2 Trough/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB) | At Day 2 of Cycle 1 | |
| Secondary | Number of Participants With Presence or Absence of Markers of Notch Signalling Pathway Inhibition in Patient Tumors (Phase Ib) | 2 weeks | The association of response or clinical benefit with the presence or absence of markers of pathway inhibition in patient tumors will be tested using Fisher's exact test. |
| Secondary | Progression-free Survival (Phase II) | Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years | Progression-free survival curves will be generated using Kaplan-Meier methodology. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Objective Response | 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 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Maximum-tolerated Dose for Cisplatin, Vinblastine and TMZ | 21 days | mg/m2 | NUMBER | |
| PRIMARY | Overall Survival (Phase II) | Up to 2 years | participants | NUMBER | |
| PRIMARY | Maximum Tolerated Dose for RO4929097 | 21 days | mg/day | NUMBER | |
| SECONDARY | Participants' Change in Protein Levels | Baseline up to 2 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cycle 1 AUC/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB) | Days 4 and 5 | hr·ng/mL | MEAN | |
| SECONDARY | Cycle 1 C Max/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB) | At Cycle 1 | ng/mL | MEAN | |
| SECONDARY | Cycle 1 Mean Day 2 Trough/Pharmacokinetics of Gamma-secretase Inhibitor RO4929097 in Combination With Temozolomide (Phase IB) | At Day 2 of Cycle 1 | ng/mL | MEAN | |
| SECONDARY | Number of Participants With Presence or Absence of Markers of Notch Signalling Pathway Inhibition in Patient Tumors (Phase Ib) | 2 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (Phase II) | Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years | months | MEDIAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Objective Response | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | Partial Response (PR) | 3 | Participants | |
| Overall Objective Response | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | Stable Disease (SD) | 3 | Participants | |
| Overall Objective Response | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | Progression of Disease (POD) | 6 | Participants | |
| Maximum-tolerated Dose for Cisplatin, Vinblastine and TMZ | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | Cisplatin | 20 | mg/m2 | |
| Maximum-tolerated Dose for Cisplatin, Vinblastine and TMZ | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | Vinblastine | 1.2 | mg/m2 | |
| Maximum-tolerated Dose for Cisplatin, Vinblastine and TMZ | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | Temozolomide | 150 | mg/m2 | |
| Overall Survival (Phase II) | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | Partial Response | 3 | participants | |
| Overall Survival (Phase II) | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | Stable Disease | 5 | participants | |
| Overall Survival (Phase II) | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | Progression of Disease | 6 | participants | |
| Maximum Tolerated Dose for RO4929097 | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 15 | mg/day |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 14 | |
| Overall Study | COMPLETED | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 12 | |
| Overall Study | NOT COMPLETED | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 2 |
Source ClinicalTrials.gov
Adverse events49
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Blood and lymphatic system disorders | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 4 | 14 | |
| other | Alkaline phosphatase increased | Metabolism and nutrition disorders | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 2 | 14 | |
| other | Anemia | Blood and lymphatic system disorders | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 11 | 14 | |
| other | Anorexia | General disorders | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 1 | 14 | |
| other | Aspartate aminotransferase increased | Blood and lymphatic system disorders | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 2 | 14 | |
| other | Blood bilirubin increased | Metabolism and nutrition disorders | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 2 | 14 | |
| other | CPK increased | Blood and lymphatic system disorders | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 1 | 14 | |
| other | Constipation | Gastrointestinal disorders | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 1 | 14 | |
| other | Creatinine increased | Metabolism and nutrition disorders | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 4 | 14 | |
| other | Diarrhea | Gastrointestinal disorders | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 1 | 14 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | ||
| Total, other adverse events | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 13 | 14 |
| Total, serious adverse events | Treatment (RO4929097, Cisplatin, Vinblastine, Temozolomide) | 11 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA008748 | Cancer Center Support Grant | Rudin, Charles M. | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| U01CA069856 | Early Clinical Trials of New Anti-Cancer Agents with Phase 1 Emphasis | SPRIGGS, DAVID R | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1995 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01196416
GET https://conductscience.org/api/trials/v1/NCT01196416/events?page=2