Overview

Dose Escalation Study of Gemcitabine and ON 01910.Na in Solid Tumors

Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
Summary
Treatment of cancer is often more effective when two or more drugs are used together. For example, when gemcitabine, an approved drug, and ON 01910.Na, a new investigational anti-cancer drug, are used together to treat cancer cells in laboratory animals, there is more inhibition of the growth of the cancer cells compared to either drug used by itself. These results offer promise that gemcitabine and ON 01910.Na could be used to treat cancer in patients. However, before studies that seek to find out if gemcitabine and ON 01910.Na is an effective combination in patients can be done, doctors must first know what is largest, safe dose of ON 01910.Na that can be used in combination with gemcitabine. This study is designed to answer that question.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Onconova Therapeutics, Inc.
Treatments:
Gemcitabine
Glycine
ON 01910
Criteria
Inclusion Criteria:

- Patients with histologically confirmed solid malignancy for which standard curative or
palliative measures do not exist or are no longer effective; or patients with a
clinical rationale for a gemcitabine-based therapy.

- The last radiotherapy/chemotherapy dose must have been given ≥4 weeks prior to study
drug initiation; with any acute or chronic adverse events of prior radiotherapy or
chemotherapy having resolved to
- Patients must have a life expectancy of at least 12 weeks and an ECOG performance
status of <1.

- Patients must be >18 years of age.

- Patients must have evaluable disease, either with informative tumor markers, or with
measurable disease on imaging, by RECIST (Response Evaluation Criteria in Solid
Tumors) criteria (Appendix II).

- Patients must have adequate liver and renal function as defined by serum creatinine no
greater than 2.0 times the institution's upper normal limits (or a 24 hour creatinine
clearance of >50 ml/min) and total bilirubin level no greater than 2.0 times the
institution's upper normal limits and transaminase levels no higher than 3.0 times the
institution's upper normal limits. (Note that patients with primary liver cancer or
hepatic metastases may have a total bilirubin value of up to 1.5 mg/dl and
transaminase levels of up to 5.0 times the limit of normal).

- Patients must have adequate bone marrow function as defined by a granulocyte count of
>1,500/mm3, platelet count of >100,000/mm3, and hemoglobin >9 g/dl.

- Patients at the expanded phase at the MTD must be willing and able to undergo blood
sampling for pharmacokinetic studies in Course 1.

- For patients in the expanded phase at the MTD, tumor amenable to a single tumor
biopsy, and willingness to undergo a baseline tumor biopsy.

- Patients must sign an informed consent form indicating that they are aware of the
investigational nature of this study and in keeping with the policies of the
institution.

Exclusion Criteria:

Patients will be excluded if:

- They have evidence of active heart disease including myocardial infarction within the
previous 3 months; symptomatic coronary insufficiency or heart block; uncontrolled
congestive heart failure; moderate or severe pulmonary dysfunction.

- They have an active infectious process.

- They have active central nervous system metastases.

- They have received prior radiotherapy administered to more than 30% of marrow-bearing
bone mass.

- They have ascites requiring active medical management including paracentesis more than
twice a month or hyponatremia (defined as serum sodium value of <134 Meq/L).

- Women who are pregnant or lactating.

- Male patients with female sexual partners who are unwilling to follow the strict
contraception requirements described in this protocol (see Section 5.4).

- Patients who have had major surgery without full recovery or major surgery within 3
weeks of ON 01910.Na treatment start.