Cancer Clinical Trial
Official title:
Phase I Dose Escalation Study of ON 01910.Na by 3-day Continuous Infusion in Patients With Advanced Cancer
The primary objective of this study is to determine the largest dose of ON 01910.Na (rigosertib sodium) that can be given safely as a 3-day continuous infusion once every 2 weeks (2-week cycle) in patients with advanced cancer.
This was an open-label, single-center, dose-escalating Phase I study to determine the
Dose-Limiting Toxicities (DLTs) and Recommended Phase 2 Dose (RPTD) of ON 01910.Na
(rigosertib sodium) administered as a 3 day continuous intravenous (CIV) infusion every 2
weeks (2-week cycles) to up to 28 patients with advanced cancer (12 to 16 in the dose
escalation phase and up to 12 additional patients in the dose confirmation phase). The
dosing of rigosertib was based on body surface area (BSA), with a starting dose of 50
mg/m2/24 hour for 3 consecutive days.
In the absence of toxicity after at least a 3-week observation period, rigosertib doses were
escalated following a Fibonacci scheme with an initial accelerated dose-escalation phase in
which 1-patient cohorts received rigosertib for 3 weeks until drug-related Grade 2 toxicity
(according to Common Toxicity Criteria for Adverse Events [CTCAE] v.3), excluding alopecia,
occurred, at which time 2 additional patients were added to subsequent cohorts. If none of
the 3 patients in the cohort experienced DLTs, the dose was escalated by a half-Fibonacci
step. If a DLT was seen in the first patient of a cohort, dosing went back a half-step. The
next dose level occurred if no DLT was reported in the 3 patients or if no more than 1 DLT
occurred in an expanded cohort of 6 patients. If a DLT was seen in 1 of the 3 patients, 3
additional patients were enrolled in the cohort. If DLTs were seen in 2 of 6 patients in a
cohort, dose escalation was stopped.
Once the maximum administered dose (MAD) was attained and the RPTD was determined, the dose
escalation phase was considered complete. Up to 12 additional patients with histologically
confirmed malignant tumors were tested at the RPTD dose to confirm its appropriateness.
Secondary objectives were to determine the qualitative and quantitative toxicity and
reversibility of toxicity of rigosertib administered in this fashion; to investigate the
clinical pharmacology of rigosertib when administered in this fashion, including plasma
pharmacokinetics at each dose level; to confirm the appropriateness of the RPTD; to document
any observed antitumor activity of rigosertib; and, to evaluate the biological effect of
rigosertib in biomarkers in serum and/or peripheral blood mononuclear cells.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
| Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
| Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
| Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
| Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
| Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
| Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
| Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
| Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
| Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
| Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
| Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
| Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
| Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
| Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
| Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
| Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
| Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|