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Advanced Solid TumorsPhase 1NCT01215864

Study of Intravenous TCD-717 in Patients With Advanced Solid Tumors

A Phase 1 study testing TCD-717 in people with Advanced Solid Tumors, run by Traslational Cancer Drugs Pharma, SL at 2 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

This is a Phase I dose escalation study of TCD-717, a novel drug that is a specific inhibitor of the enzyme choline kinase alpha, in patients with advanced solid tumors. The objectives of this study are to evaluate the safety of the drug and to determine the maximum tolerated dose and appropriate dose for phase II… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
TCD-717
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesUnited States
Study dates
Jan 2011to Feb 2014
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

  • Patients must have histologically-confirmed solid tumors, metastatic or recurrent and refractory after standard therapy for the disease or for which conventional therapy is not reliably effective or no effective therapy is available.
  • Where possible, it is recommended that a paraffin block of tumor tissue or slides containing sections of tumor tissue be available (a sample should be collected and stored appropriately for the potential evaluation of choline kinase alpha expression in tumor tissue at the end of the study).
  • Patients must be ≥ 18 years of age.
  • Patients must have an ECOG Performance Status of 0, 1 or 2 and an estimated life expectancy of ≥ 12 weeks.
  • Patients must have adequate clinical laboratory values (i.e., absolute neutrophil count ≥1.5x10^9/L, platelets ≥100x10^9/L, plasma creatinine <= 1.5 x upper limit of normal (ULN) for the institution or a calculated creatinine clearance (using Cockroft and Gault formula) of ≥ 60 mL/min/1.73 m^2; bilirubin < 1.5 x ULN, alanine transaminase (ALT) and aspartate transaminase (AST) < 2.5 x ULN or ≤ 5 x ULN with liver involvement.
  • Patients may have either measurable or non-measurable disease as defined by RECIST.
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  • Patients must give signed informed consent prior to the start of any study specific procedures.
  • Female patients with reproductive potential must have a negative serum or urine pregnancy test.
  • Patients with reproductive potential and their partners must be using at least one form of contraception as approved by the Investigator prior to study entry.
  • Patients with central nervous system metastases may be included if they are stable without administration of steroids. Patients with unstable metastatic CNS disease are excluded.

Who cannot join

  • Patients will be excluded if they have received previous anti-cancer chemotherapy, immunotherapy, vaccines, monoclonal antibodies, anti-angiogenic therapy, radiotherapy or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study entry. Patients receiving concurrent anticancer therapy or intending to receive this at any time during the study will be excluded.
  • Patients who have received extensive prior radiotherapy to more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation at any time prior to the study.
  • Patients with any concomitant condition that could compromise the objectives of this study and the patient's compliance.
  • Patients with significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions, history of myocardial infarction within six months of study entry, uncontrolled dysrhythmias or poorly controlled angina, uncontrolled hypertension or elevated heart rate.
  • Patients with a history of serious ventricular arrhythmia (VT or VF), QTc >=450 msec for men and 470 msec for women (as indicated in the ECG taken in the pre-treatment evaluation), or left ventricular ejection fraction (LVEF)<=50% by MUGA or Echocardiogram performed at the pre-treatment evaluation.
  • Pregnant or lactating females.
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  • Patients with clinically evident HIV, HBV or HCV infection.
  • Patients with a hematologic malignancy.
  • Patients with a documented or known bleeding disorder or who require anticoagulation treatment that increases international normalized ratio (INR) or activated partial thromboplastin time (aPTT) above the institutional upper limit of normal.
  • Patients with clinically significant retinal abnormalities as per the medical history or ophthalmologic findings in the pre-treatment evaluation (e.g., retinitis pigmentosa or macular degeneration).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: A Multicenter Phase I Study of TCD-717 Given by 4-Hour Intravenous Infusion in Patients With Advanced Solid Tumors

This is a Phase I dose escalation study of TCD-717, a novel drug that is a specific inhibitor of the enzyme choline kinase alpha, in patients with advanced solid tumors. The objectives of this study are to evaluate the safety of the drug and to determine the maximum tolerated dose and appropriate dose for phase II studies. Secondary objectives are to measure the efficacy of TCD-717; and in a substudy to be conducted in the MTD confirmation cohort only, to evaluate the potential correlation between the levels of tumor choline and tumor response to the choline kinase alpha inhibitor, TCD-717, using magnetic resonance spectroscopy. Pharmacokinetics analysis will be performed on patients enrolled in the maximum tolerated dose confirmation cohort.

Read the detailed description

TCD Pharma has developed TCD-717, a novel drug that is a specific inhibitor of the enzyme choline kinase alpha (ChoKα), involved in the synthesis of phosphatidylcholine, which constitutes the major phospholipid in eukaryotic cell membranes and has been described as a potent oncogen when overexpressed in human cells. TCD-717 will be evaluated in this Phase I, open-label, single arm study to be performed at multiple centers. TCD-717 will be administered as a 4 hour infusion on two separate days per 7-day period per 28-day cycle (8 administrations per cycle). Eligible patients must have confirmed, metastatic or recurrent/refractory solid tumors.

Being tested
TCD-717
Keywords
metastatic tumors, refractory tumors, recurrent tumors
Medical subject headings
Neoplasm Metastasis, Neoplasms

What participants receive

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

  • TCD-717Drug

    Patients will receive TCD-717 at the following dose levels:

    2, 4, 7, 10, 14, 19, 25, 31, 39, 49 or 61 mg/m^2

Study groups in NCT01215864
Study groupRoleWhat they receive
TCD-717ExperimentalNot described
Receives: Drug: TCD-717

What is being measured

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

  1. Safety of TCD-717 given by 4-hour intravenous infusion

    Patients will be monitored throughout the study for adverse events and dose limting toxicities.

    Measured: Duration of the study

Secondary outcomes (3)

  1. Antitumor activity of TCD-717 given by 4-hour intravenous infusion

    Efficacy of TCD-717 will be asessed by RECIST 1.1

    Measured: Duration of study

  2. MTD confirmation cohort only: Pharmacokinetics (PK) of TCD-717 given by 4-hour infusion

    For patients enrolled in MTD confirmation cohort, PK (Cmax, Tmax, AUC) will be measured during Cycle 1

    Measured: Day 1-28 of Cycle 1

  3. To evaluate the potential correlation between the levels of tumor choline and tumor response to the choline kinase alpha inhibitor TCD-717 using magnetic resonance spectroscopy (MRS) (Substudy, MTD confirmation cohort only).

    MTD confirmation cohort only

    Measured: First scan will be pre-treatment (within 2 wks prior to start of treatment), then on Cycle 1 Day 25, and then within 7 days after determining disease progression

Timeline

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

  1. First posted7 Oct 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionFeb 2014
  4. Study completionFeb 2014

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
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01215864
Sponsor's protocol ID
T10-10646
Status last verified
Aug 2014
First submitted
5 Oct 2010
Last updated
8 Aug 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TCD-717 in people with Advanced Solid Tumors, run by Traslational Cancer Drugs Pharma, SL at 2 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 10 inclusion and 10 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 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Safety of TCD-717 given by 4-hour intravenous infusion (time frame: Duration of the study). 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 NCT01215864.

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 8 Aug 2014.

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