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TumorsPhase 1NCT01837667

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

A Phase 1 study testing LB-100 for Injection and Docetaxel in people with Tumors and Neoplasms, run by Lixte Biotechnology Holdings, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tumors, Neoplasms, Cancer
What is being tested?
LB-100 for Injection and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
5 sitesUnited States
Study dates
Feb 2013to Sep 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 <= 1.5 x upper limit of normal (ULN) for the institution or 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.
  • 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.

Who cannot join

  • 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.
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  • 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 a history of central nervous system (CNS) malignancy.
  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

Other trials in United States

About this study

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

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.

Conditions
Tumors, Neoplasms, Cancer
Being tested
LB-100 for Injection, Docetaxel
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LB-100 for InjectionDrug

    Part 1 and Part 2: LB-100 for Injection infusion on Days 1,2,3 of each 21 day cycle.

  • DocetaxelDrug

    Also called Taxotere

    Part 2: Docetaxel infusion on Day 2 of each 21 day cycle.

Study groups in NCT01837667
Study groupRoleWhat they receive
LB-100 for Injection and DocetaxelExperimentalPart 1: LB-100 infusion. Part 2: LB-100 infusion and docetaxel infusion.
Receives: Drug: LB-100 for Injection; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01837667
Sponsor's protocol ID
L12-20661
Status last verified
Sep 2016
First submitted
18 Apr 2013
Last updated
24 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • Chung V, Mansfield AS, Braiteh F, Richards D, Durivage H, Ungerleider RS, Johnson F, Kovach JS. Safety, Tolerability, and Preliminary Activity of LB-100, an Inhibitor of Protein Phosphatase 2A, in Patients with Relapsed Solid Tumors: An Open-Label, Dose Escalation, First-in-Human, Phase I Trial. Clin Cancer Res. 2017 Jul 1;23(13):3277-3284. doi: 10.1158/1078-0432.CCR-16-2299. Epub 2016 Dec 30.

    PubMed 28039265

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LB-100 for Injection and Docetaxel in people with Tumors and Neoplasms, run by Lixte Biotechnology Holdings, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01837667, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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