Phase I Safety and Pharmacokinetic Study of QBI-139 Injection Administered by Weekly Intravenous Infusion in Patients with Refractory Malignancies
David S. Hong
The goal of this clinical research study is to find the highest tolerable dose of QBI-139 that can be given to patients with solid tumors. The safety of this drug will also be studied.
Disease Group: Advanced Cancers,Solid Tumors
Treatment Agent: QBI-139
Treatment Location: Both at MD Anderson & outside MD Anderson at one or more Collaborating Sites or Institutions
Estimatated Length of Stay in Houston: N/A
Sponsor: Quintessence Biosciences, Inc.
Return Visit: Screening 9 on-study visits up to Cycle 3 End-of-study visit
Home Care: N/A
Primary Objectives To evaluate the toxicity and tolerability of QBI-139 in patients with advanced refractory solid tumors. To determine the maximum tolerated dose of QBI-139 in patients with advanced, refractory solid tumors. Secondary Objectives To evaluate the patient response rate to QBI-139 using the RECIST criteria. To evaluate the pharmacokinetics of QBI-139 in humans. To determine the frequency and nature of serum antibody production to QBI-139.
IRB Review and Approval Date: 01/19/2010
Recruitment Status: Closed
Projected Accrual: 72
1) Subjects must be refractory to or intolerant of established therapy
known to provide clinical benefit for their condition, i.e., patients
must not be candidates for regimens known to provide clinical benefit;
patients must have measurable (as defined by Response Evaluation
Criteria in Solid Tumors (RECIST) criteria) solid tumors.
2) Prior chemotherapy and radiation therapy are allowed (at least 4 weeks must have passed from prior chemotherapy and radiotherapy (6 weeks for nitrosoureas or mitomycin C), provided that clinically significant toxicity related to prior chemotherapy or radiotherapy has returned to baseline or National Cancer Institute (NCI) Common Toxicity and Adverse Events (CTCAE) grade </= 2 and are not expected to recover further. The toxicities specifically exclude alopecia.
3) Age >/= 18 years
4) ECOG performance status </= 2.
5) Life expectancy of greater than 12 weeks, as estimated by the treating physician.
6) Patients must have normal organ and marrow function as defined below: leukocytes >/= 3,000/uL; absolute neutrophil count >/= 1,500/uL; platelets >/= 100,000/uL; total bilirubin within normal institutional limits; AST(SGOT)/ALT(SGPT) </= 2.5 X institutional ULN; serum creatinine < 1.5X institutional ULN OR creatinine clearance >/= 45 mL/min/1.73 m2, as calculated by Cockroft-Gault formula, for patients with creatinine levels above institutional normal. A 24 hr urine collection and creatinine clearance can be measured if indicated.
7) Both men and women should not attempt to conceive and women should not be pregnant or breast-feeding while taking part in this study (or for 90 days after completing the study). If sexually active, both men and women must agree to use an effective method of birth control while taking the study drug. Barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (IUD’s), hormonal contraceptives, oral contraceptive pills, surgical sterilization, and complete abstinence are examples of effective methods.
8) Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Both men and women and members of all races and ethnic groups are eligible for this trial.
9) Ability to understand and the willingness to sign a written informed consent document.
1) Concurrent treatment with an investigational agent other than the
investigational agent(s) used in this study OR treatment within 4 weeks
of study entry with any investigational agent(s) or device(s).
2) Failure to recover fully (as judged by the Investigator) from prior surgical procedures.
3) Patients with known brain metastases (previously treated or currently active) or leptomeningeal carcinomatosis
4) Patients who have had a gastrointestinal bleed requiring transfusion within the past 6 months or active Grade 2 or higher diarrhea
5) Treatment with Ranpirnase (Onconase®)
6) Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
7) Women who are pregnant or breastfeeding
8) Patients known to have HIV are ineligible
9) Patients with known immunocompromised status or organ transplants will be excluded
10) Patients must not have: a) unstable angina (anginal symptoms at rest) within the past 6 months or b) myocardial infarction within the past 6 months or c) new onset angina within the last 3 months.
11) QT prolongation (defined as QTc >450 msec for males and QTc >470 msec for females)
Information and next steps
Advanced Cancers,Solid Tumors
David S. Hong
Investigational Cancer Therapeutics
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