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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Tumors, Neoplasms, Cancer

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Trial Information

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


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, 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. Pregnant or breastfeeding women.

6. 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.

7. Patients with known active human immunodeficiency virus (HIV), hepatitis B virus
(HBV), or hepatitis C virus (HCV) infection.

8. 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).

9. Part 2 only: Patients with >= grade 2 peripheral neuropathy.

10. Patients with an underlying diagnosis or disease state associated with an increased
risk of bleeding.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of patients with adverse events as a measure of safety and tolerability of LB-100 for Injection treatment plus docetaxel.

Outcome Time Frame:

Starting from date of first dose up to 30 days after last dose.

Safety Issue:

Yes

Principal Investigator

Vincent Chung, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope National Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

L12-20661

NCT ID:

NCT01837667

Start Date:

February 2013

Completion Date:

December 2014

Related Keywords:

  • Tumors
  • Neoplasms
  • Cancer
  • Neoplasms

Name

Location

City of Hope National Medical CenterLos Angeles, California  91010