Phase I Study of LB-100 With Docetaxel in Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Lixte Biotechnology Holdings, Inc.
Sponsor:
Information provided by (Responsible Party):
Lixte Biotechnology Holdings, Inc.
ClinicalTrials.gov Identifier:
NCT01837667
First received: April 18, 2013
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Tumors
Neoplasms
Cancer
Drug: LB-100 for Injection
Drug: Docetaxel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Lixte Biotechnology Holdings, Inc.:

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: 42
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Docetaxel
Part 2: Docetaxel infusion on Day 2 of each 21 day cycle.
Other Name: Taxotere

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.

  2. Part 2 only: Patients must be docetaxel-naive.
  3. Patients must have a life expectancy of at least 12 weeks.
  4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  5. Patients must be men and women >= 18 years of age.
  6. Patients must have recovered from all acute adverse effects (excluding alopecia) of prior therapies to baseline or <= grade 1 prior to study entry.
  7. 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.
  8. 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).
  9. 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.
  10. Female patients of childbearing potential must have a negative serum or urine pregnancy test result at time of pre-treatment screening.
  11. 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.
  12. 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.

Exclusion Criteria:

  1. 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.
  2. Part 2 only: Patients may not have had prior treatment with docetaxel.
  3. 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.
  4. 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.
  5. 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).
  6. Pregnant or breastfeeding women.
  7. 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.
  8. Patients with known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
  9. 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).
  10. Part 2 only: Patients with >= grade 2 peripheral neuropathy.
  11. Patients with an underlying diagnosis or disease state associated with an increased risk of bleeding.
  Contacts and Locations
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

Locations
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Kathleen Kelly, BSN    626-256-4673 ext 60076    kkelly@coh.org   
Principal Investigator: Vincent Chung, MD, FACP         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office    507-538-7623      
Principal Investigator: Aaron Mansfield, MD         
Sponsors and Collaborators
Lixte Biotechnology Holdings, Inc.
Investigators
Principal Investigator: Vincent Chung, MD, FACP City of Hope National Medical Center
Principal Investigator: Aaron Mansfield, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Lixte Biotechnology Holdings, Inc.
ClinicalTrials.gov Identifier: NCT01837667     History of Changes
Other Study ID Numbers: L12-20661
Study First Received: April 18, 2013
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014