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Phase I Dose Escalation Study of ON 01910.Na by 24 Hour Continuous Infusion Per Week in Patients With Advanced Cancer

Phase 1
18 Years
Not Enrolling
Solid Tumors, Advanced Cancer, Cancer, Neoplasms

Thank you

Trial Information

Phase I Dose Escalation Study of ON 01910.Na by 24 Hour Continuous Infusion Per Week in Patients With Advanced Cancer

This is an open-label, dose-escalating Phase I study of ON 01910.Na in patients with
advanced cancers, who have satisfied the inclusion/exclusion criteria enumerated in this
protocol. Patients will receive ON 01910.Na intravenously by 24 hour continuous infusion
once every week (3 weeks per cycle), until evidence of disease progression, intolerable
adverse events, or withdrawal of patient consent. Safety monitoring will be done for at
least 3 weeks before escalation to the next dose level. As of Amendment 7, up to 6 patients
with gynecological malignancies will be enrolled at the 2400 mg/m2 dose level to determine
the appropriateness of this dose as the Recommended Phase Two Dose (RPTD).

Inclusion Criteria:

- Must have histologically confirmed solid tumor (leukemias and lymphomas excluded)
malignancy that is incurable and for which standard (FDA approved or established
standard clinical practice), curative, or palliative measures do not exist or are no
longer effective.

- Patients with disease amenable to sequential biopsies will be requested to undergo
two tumor biopsies and two normal skin biopsies, but patients may decline and still
be eligible for enrollment during this escalation stage.

- At least 3 weeks since the last dose of other potentially myelosuppressive treatment
(at least 6 weeks since last dose of nitrosoureas or mitomycin C) and recovery from
manifestations of reversible drug toxicity (alopecia, stable residual neuropathy, and
residual hand and foot syndrome are excluded). Patients with prior doxorubicin
chemotherapy must have total cumulative dose of no more than 450 mg/m2.

- Patients with prior radiotherapy are eligible provided a minimum of 4 weeks have
passed and the maximal area of hematopoietic active bone marrow treated was less than

- ECOG performance status ≤2.

- Patients must have nearly normal organ and marrow function as defined below:

- Hgb > 9 gm/dl (must not require transfusional support but erythropoietin therapy is

- WBC > 4,000 per microliter

- Absolute neutrophil count > 1,500 per microliter

- Platelets ≥ 100,000 per microliter

- Total bilirubin within 1.5 times institutional upper normal limit

- AST(SGOT)/ALT(SGPT) ≤ 2.5 x institutional upper normal limit. (If liver function
abnormalities are due to metastatic disease, patients are eligible provided the
transaminases are < 5 times institutional upper normal limit. Patients with primary
liver disease with these parameters will be ineligible.)

- Serum creatinine within normal institutional limits or estimated creatinine clearance
>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry.

- Ability to understand and the willingness to sign a written informed consent

- All ethnic groups are eligible for this trial.

Inclusion Criteria - Dose Confirmation Phase Same inclusion criteria as in the Dose
Escalation phase described above, except Patients must have an ECOG performance of 0 or 1.

Exclusion Criteria:

- Recent major surgery (within the past 14 days), chemotherapy within 3 weeks (6 weeks
for nitrosoureas or mitomycin C) or radiotherapy within 4 weeks prior to entering the
study, or those who have not recovered from adverse events (except alopecia, stable
residual neuropathy, and residual hand and foot syndrome) due to previously
administered agents.

- Patients may not be on any other investigational agents or concurrent chemotherapy,
radiotherapy, hormonal treatments, bone marrow transplantation, or immunotherapy.
Patients who have previously had a Bone Marrow Transplant are excluded from this

- Known brain metastases, except brain metastases that have been previously removed or
irradiated and currently have no clinical impact.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to ON 01910.Na.

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, bleeding, symptomatic congestive heart failure, unstable angina pectoris,
cardiac arrhythmia, or psychiatric illness/social situations that would limit
compliance with study requirements.

- Pregnant and nursing women are excluded.

- HIV-positive patients receiving combination anti-retroviral therapy are excluded.

- Ascites requiring active medical management including paracentesis, peripheral
bilateral edema, hyponatremia (serum sodium value less than 134 Meq/L).

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of dose limiting toxicities (DLTs)

Outcome Description:

DLTs are defined as: Grade 3 non-hematological toxicity other than nausea, vomiting, diarrhea, fever, stomatitis, esophagitis/dysphagia. Recurrent grade 3 toxicity uncontrolled by optimal therapy or Grade 4 nausea, vomiting, diarrhea and fever. Grade 3 stomatitis and/or esophagitis/dysphagia for > 5 days. Grade 4 neutropenia or thrombocytopenia for > 5 days measured at least 2X 2-3 days apart. Neutropenic fever, as defined in Protocol. Failure to recover neutrophils (> 1,500 per microliter) or platelets (>75,000 per microliter) before the next weekly dose.

Outcome Time Frame:

21 days after first administration of ON 01910.Na

Safety Issue:


Principal Investigator

Sridhar Mani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University


United States: Food and Drug Administration

Study ID:

Onconova 04-03



Start Date:

June 2006

Completion Date:

November 2011

Related Keywords:

  • Solid Tumors
  • Advanced Cancer
  • Cancer
  • Neoplasms
  • ON 01910.Na
  • rigosertib sodium
  • rogosertib
  • Neoplasms



Albert Einstein Cancer CenterBronx, New York  10461