Phase I Study of LB-100 With Docetaxel in Solid Tumors
Verified December 2013 by Lixte Biotechnology Holdings, Inc.
Information provided by (Responsible Party):
Lixte Biotechnology Holdings, Inc.
First received: April 18, 2013
Last updated: December 12, 2013
Last verified: December 2013
The purpose of this study is to test the safety of an investigational drug called LB 100 for Injection for treatment of solid tumors, when given with or without docetaxel. LB-100 is a small molecule that in laboratory and animal studies has shown activity when used by itself or together with drugs approved to treat some types of cancer (chemotherapeutic agents). Docetaxel is a drug that has been approved for the treatment of some types of cancer; one of the trade names for docetaxel is Taxotere®. The study is in 2 parts. Part 1: Patients will receive injections of LB-100. Part 2: Patients will receive injections of LB-100 and docetaxel. This is the first study where LB-100 for Injection will be used in humans.
Drug: LB-100 for Injection
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase I Study of Intravenous LB-100 for Injection as a Single Agent and in Combination With Docetaxel in the Treatment of Patients With Advanced Solid Tumors
Primary Outcome Measures:
- Number of patients with adverse events as a measure of safety and tolerability of LB-100 for Injection treatment plus docetaxel. [ Time Frame: Starting from date of first dose up to 30 days after last dose. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
Experimental: LB-100 for Injection and Docetaxel
Part 1: LB-100 infusion. Part 2: LB-100 infusion and docetaxel infusion.
Drug: LB-100 for Injection
Part 1 and Part 2: LB-100 for Injection infusion on Days 1,2,3 of each 21 day cycle.
Part 2: Docetaxel infusion on Day 2 of each 21 day cycle.
Other Name: Taxotere
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Part 1 only: Patients with histologically or cytologically proven progressive or metastatic solid tumors who have failed standard treatment and have no other effective treatment available.
Part 2 only: Patients with histologically or cytologically proven progressive or metastatic solid tumors who have failed standard treatment and have no other effective treatment available, or docetaxel-naive patients who have failed standard treatment and have tumors for which a docetaxel-based regimen would be appropriate.
- Part 2 only: Patients must be docetaxel-naive.
- Patients must have a life expectancy of at least 12 weeks.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients must be men and women >= 18 years of age.
- Patients must have recovered from all acute adverse effects (excluding alopecia) of prior therapies to baseline or <= grade 1 prior to study entry.
- Patients must have adequate bone marrow function, defined as an absolute neutrophil count >= 1.5 x 10^9/L and a platelet count >= 100 x 10^9/L.
- Patients must have adequate renal function, defined as serum creatinine <= 1.2 mg/dL (if > 1.2 mg/dL, a calculated creatinine clearance [Cockcroft-Gault method] must be >= 60 mL/min/1.73 m^2).
Patients must have adequate hepatic function, defined as:
- Part 1 only: plasma total bilirubin <= 1.5 mg/dL, alanine transaminase (ALT) and aspartate transaminase (AST) <= 2.5 X ULN (upper limit of normal).
- Part 2 only: plasma total bilirubin <= ULN; ALT and/or AST <= 1.5 X ULN concomitant with alkaline phosphatase <= 2.5 X ULN.
- Female patients of childbearing potential must have a negative serum or urine pregnancy test result at time of pre-treatment screening.
- Patients with reproductive potential must agree to use at least one form of barrier contraception prior to study entry and for up to 30 days beyond the last administration of study drug.
- Patients must be capable of providing informed consent and must be willing to provide written informed consent prior to the start of any study-specific procedures.
- Patients may not have had prior chemotherapy, radiotherapy, hormonal therapy, or biologic therapy in the 4 weeks prior to study entry with the exception of mitomycin C or nitrosoureas, for which patients must be 6 weeks from prior treatment. For patients who have been treated with targeted therapy, 5 half-lives of that therapy (or 28 days, whichever is shorter) must have passed prior to enrollment in the study.
- Part 2 only: Patients may not have had prior treatment with docetaxel.
- Part 2 only: Patients with plasma total bilirubin > ULN; ALT and/or AST > 1.5 X ULN concomitant with alkaline phosphatase > 2.5 X ULN.
Patients may not have any concomitant condition that could compromise the objectives of this study and the patients' compliance and ability to tolerate this therapy and complete at least 2 cycles of therapy, including, but not limited to the following:
- Congestive heart failure or uncontrolled angina pectoris, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension, or dysrhythmias.
- Active infection.
- Unstable diabetes mellitus.
- Psychiatric disorder that may interfere with consent and/or protocol compliance.
- Uncontrolled seizure activity.
- Prior history of inflammatory bowel disease.
- Prior history of pulmonary fibrosis.
- Prior history of cardiomyopathy.
- Patients with known brain metastases (due to their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events).
- Pregnant or breastfeeding women.
- Patients with another malignancy in the past 3 years except: curatively treated non-melanoma skin cancer, or carcinoma in situ (either cervix or breast) that does not require further treatment.
- Patients with known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- Part 2 only: Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 (for example, drugs formulated with polysorbate 80 include, but are not limited to: Aranesp, Eprex, Cordarone, some vaccines).
- Part 2 only: Patients with >= grade 2 peripheral neuropathy.
- Patients with an underlying diagnosis or disease state associated with an increased risk of bleeding.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01837667
|City of Hope National Medical Center
|Duarte, California, United States, 91010 |
|Contact: Kathleen Kelly, BSN 626-256-4673 ext 60076 email@example.com |
|Principal Investigator: Vincent Chung, MD, FACP |
|Rochester, Minnesota, United States, 55905 |
|Contact: Clinical Trials Office 507-538-7623 |
|Principal Investigator: Aaron Mansfield, MD |
Lixte Biotechnology Holdings, Inc.
||Vincent Chung, MD, FACP
||City of Hope National Medical Center
||Aaron Mansfield, MD
No publications provided
||Lixte Biotechnology Holdings, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 18, 2013
||December 12, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Molecular Mechanisms of Pharmacological Action