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ON 01910.Na and irinotecan

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Traws Pharma, Inc.|Last Updated: Jun 23, 2017

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

ON 01910.Na and irinotecan · 1 trial · 1 indication

Phase 1 1
NCT00861328Safety Study of ON 01910.Na in Combination With Irinotecan or OxaliplatinAdvanced Solid Tumors
COMPLETED18 Analytics
PHASE1COMPLETED
Safety Study of ON 01910.Na in Combination With Irinotecan or Oxaliplatin
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

maximum tolerated dose
1 - 3 months

Secondary Endpoints

Pharmacokinetic parameters
1 month
tumor measurements
1 - 3 months
tumor markers
1 - 3 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTALTreatment of escalating doses of ON 01910.Na in combination with irinotecan
BEXPERIMENTALTreatment of escalating doses of ON 01910.Na in combination with oxaliplatin

Interventions

NameTypeDescription
ON 01910.Na and irinotecanDRUGON 01910.Na will be administered by IV infusion over 24 hours once per week in a 6-week cycle (6 doses per cycle). The dose of ON 01910.Na will start at 250 mg/m2 and will proceed to higher dose levels after safety evaluation. The suggested starting dose of Irinotecan is 180 mg/m2 administered by intravenous (IV) infusion over 90 minutes every 2 weeks of a 6-week cycle (3 doses per cycle). Reductions in the starting doses according to recommendations of current approved prescribing information may be considered after review of patients' medical histories and potential tolerances to treatment with the chemotherapy agent.
ON 01910.Na and oxaliplatinDRUGON 01910.Na will be administered by IV infusion over 24 hours once per week in a 6-week cycle (6 doses per cycle). The dose of ON 01910.Na will start at 250 mg/m2 and will proceed to higher dose levels after safety review of the combination regimen in the previous cohort. The suggested starting dose of Oxaliplatin is 85 mg/m2 administered by IV infusion over 120 minutes every 2 weeks of a 6-week cycle (3 doses per cycle). Reductions in the starting doses according to recommendations of current approved prescribing information may be considered after review of patients' medical histories and potential tolerances to treatment with the chemotherapy agent.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male and female patients ≥18 years of age with histologically or cytologically confirmed solid tumors that are metastatic or progressive, for whom no standard therapy holds curative potential and for whom irinotecan or oxaliplatin are reasonable treatment options. * Patients m...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Frequently asked questions about ON 01910.Na and irinotecan

What is ON 01910.Na used for?

ON 01910.Na is an investigational small molecule being studied for the treatment of myelodysplastic syndromes, acute myelocytic leukemia, metastatic pancreatic adenocarcinoma, malignant neoplasms, and advanced solid tumors. It is being developed by Traws Pharma, Inc. for oncology indications.

Who makes ON 01910.Na?

ON 01910.Na is being developed by Traws Pharma, Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol TRAW.

What phase is ON 01910.Na in?

ON 01910.Na has completed Phase 1 and Phase 3 clinical trials. It is an investigational drug that has not been approved by the FDA. The completed trials include Phase 1 studies in leukemia and solid tumors, and Phase 3 studies in myelodysplastic syndromes and pancreatic cancer.

What clinical trials is ON 01910.Na in?

ON 01910.Na has been studied in three completed clinical trials. NCT00854646 was a Phase 1 study in refractory leukemia or myelodysplastic syndrome. NCT01125891 was a Phase 1 dose escalation study with gemcitabine in solid tumors. NCT01241500 was a Phase 3 study in refractory myelodysplastic syndrome patients with excess blasts.

Is ON 01910.Na the same as rigosertib?

ON 01910.Na is also known as rigosertib. It is a small molecule being developed by Traws Pharma, Inc. for oncology indications including myelodysplastic syndromes and pancreatic cancer.