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Malignant ThymomaPhase 2NCT01301391

Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy

A Phase 2 study testing Milciclib Maleate in people with Malignant Thymoma, run by Tiziana Life Sciences LTD at 3 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The intent of the study is to assess the antitumor activity of PHA-848125AC in patients with recurrent or metastatic, unresectable malignant thymoma previously treated with multiple lines of chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Thymoma
What is being tested?
Milciclib Maleate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
3 sitesin 2 countries
Study dates
2 Feb 2011to 17 Dec 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Signed and dated IRB/Approved Informed Consent
  • Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after more than one prior systemic therapy for advanced / metastatic disease
  • Presence of measurable disease
  • Age >=18 years old
  • ECOG performance status 0-1
  • Negative pregnancy test (if female in reproductive years)
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  • Use of effective contraceptive methods if men and women of child producing potential
  • Adequate liver function Total Serum Bilirubin <=1.5 x upper limit of normal (ULN) Transaminases (AST/ALT) <=2.5ULN (if liver metastases are present, then <=5ULN is allowed) ALP <=2.5ULN (if liver and/or bone metastases are present, then <=5ULN is allowed)
  • Adequate renal function Serum Creatinine <=ULN or Creatinine Clearance calculated by Cockcroft and Gault's formula > 60 mL/min
  • Adequate hematologic status ANC >=1,500cells/mm3 Platelet Count >= 100,000cells/mm3 Hemoglobin >=9.0g/dL
  • Two weeks must have elapsed since completion of prior chemotherapy, minor surgery, radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated)
  • Resolution of all acute toxic effects of any prior treatments to NCI CTC (Version 3.0) grade <=1

Who cannot join

  • Any of the following in the past 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
  • Grade >1 retinopathy
  • Known brain metastases
  • Known active infections
  • Pregnant or breast feeding women
  • Diabetes mellitus uncontrolled
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  • Gastrointestinal disease that would impact on drug absorption
  • Patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at baseline
  • Patients with previous history or current presence of neurological disorders (with the exception of myasthenia gravis), including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease and extra-pyramidal syndromes.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that make the patient inappropriate for entry into this study

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • NIH, Center for Cancer Research, Medical Oncology

    Bethesda, Maryland, 20892

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

Italy1 site

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

    Milan, (mi), 20133

Other trials in Italy

About this study

Official title: Phase II Study Of Oral PHA-848125AC In Patients With Malignant Thymoma Previously Treated With Multiple Lines Of Chemotherapy

The intent of the study is to assess the antitumor activity of PHA-848125AC in patients with recurrent or metastatic, unresectable malignant thymoma previously treated with multiple lines of chemotherapy.

Read the detailed description

This is a single-arm, open-label, multicenter, phase II clinical trial design with an early stopping rules. PHA-848125AC will be administered to patients with recurrent metastatic unresectable B3 thymoma or thymic carcinoma who have received more than one line of prior systemic therapy for advanced / metastatic disease. The intent of the study is to assess the antitumor activity of PHA-848125AC and ultimately to improve the outcome of the patients. The primary end point for this study is a progression free survival rate of 3 months.

Being tested
Milciclib Maleate
Keywords
B3 and C malignant thymoma
Medical subject headings
Thymoma

What participants receive

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

  • Milciclib MaleateDrug

    Also called PHA-848125AC

    150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.

    Number of cycles: until disease progression or unacceptable toxicity.

Study groups in NCT01301391
Study groupRoleWhat they receive
MilciclibExperimentalMilciclib Maleate capsules
Receives: Drug: Milciclib Maleate

What is being measured

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

  1. Progression-free Survival Rate at 3 Months

    The proportion of successes (i.e. patients alive and progression-free at 3 months since treatment start) out of the total number of evaluable patients.

    Measured: 3 months since treatment start

Secondary outcomes (6)

  1. Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters

    The adverse events (AEs) were coded with the Medical Dictionary for Regulatory Activities (MedDRA) and their severity graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The following subsets of AEs were considered: serious AEs, AEs with CTCAE grade 3-5, AEs with a relationship to study treatment classified by the Investigator as possible or probable or definite and AEs reported as leading to discontinuation from treatment.

    Laboratory test values were graded according to the NCI CTCAE scale, v3.0, whenever possible. For each laboratory test included in the NCI CTCAE system, the incidence of abnormalities were evaluated by considering the worst occurrence for each patient throughout the whole treatment period.

    Measured: Adverse events: from date treatment consent signed to 28 days after last treatment; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a maximum total of 48 two-week cycles.

  2. Objective Response Rate (ORR)

    Point and 95% confidence interval estimates was calculated for the objective tumor response rate (confirmed CRs or PRs). The determination of antitumor efficacy was based on objective tumor assessments made according to the RECIST guideline (version 1.1). The analysis was performed in the evaluable population.

    Measured: Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.

  3. Disease Control Rate (ORR+SD Rate)

    Point and 95% confidence interval estimates was calculated for the disease control rate (confirmed CRs / PRs and SD > or = 6 weeks). The analysis was performed in the evaluable patient populations.

    Measured: Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.

  4. Duration of Response

    Calculated in patients achieving a confirmed objective tumor response by RECIST version 1.1 criteria.

    Measured: Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.

  5. Overall Survival

    The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, and to the date in which the patients diagnosed with the disease are still alive. Kaplan-Meier estimates as percentage of patients alive.

    Measured: Every 6 weeks during Follow-Up until PD or new therapy start; every 6 months thereafter, up to 2 years from the last dose of study drug.

  6. Progression-free Survival (PFS)

    The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.

    Measured: Assessments were made every 6 weeks from start date until PD or up to a maximum duration of 134 weeks.

Timeline

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

  1. First posted23 Feb 2011 (estimated)
  2. Study start2 Feb 2011
  3. Primary completion31 May 2017
  4. Study completion17 Dec 2018

Why it stopped: For the last patient still on treated nominal therapeutic use of the Milciclib was approved at INT Milano.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01301391
Sponsor's protocol ID
CDKO-125a-007
Status last verified
Jan 2019
First submitted
15 Feb 2011
Last updated
6 Feb 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Milciclib Maleate in people with Malignant Thymoma, run by Tiziana Life Sciences LTD at 3 sites in 2 countries.

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 12 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: stopped early, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival Rate at 3 Months (time frame: 3 months since treatment start). 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 NCT01301391.

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 6 Feb 2019.

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