Thymic CarcinomaPhase 2NCT01011439
Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma
A Phase 2 study testing Milciclib Maleate in people with Thymic Carcinoma, run by Tiziana Life Sciences LTD at 6 sites in 3 countries.
Trial summary
The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thymic Carcinoma
- 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
- 72 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 22 Feb 2010to 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
- Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after prior chemotherapy (only one prior systemic therapy allowed)
- Presence of measurable disease
- Age >=18 years
- ECOG performance status 0-1
- Negative pregnancy test (if female in reproductive years)
- Use of effective contraceptive methods if men and women of child producing potential
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- 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, 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
6 sites in 3 countries.
6 sites in 3 countries
United States2 sites
NIH, Center for Cancer Research, Medical Oncology
Bethesda, Maryland, 20892
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, 85258
France2 sites
Hopital Larrey
Toulouse, 31059
Institut de cancerologie Gustave Roussy
Villejuif, 94805
Italy2 sites
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, (MI), 20133
Azienda Ospedaliera San Luigi Gonzaga
Orbassano, 10043
About this study
Official title: Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With Chemotherapy
The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy.
Read the detailed description
The Simon's optimal 2 stage design is adopted for this single-arm, open-label, multicenter phase II clinical trial of PHA-848125AC administered to patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy (only one prior systemic therapy allowed). The intent of the study is to assess the antitumor activity of PHA-848125AC and ultimately to improve the outcome of patients with thymic carcinoma who have already exploited one chemotherapy option. The primary end point for this study is a progression free survival rate of 3 months.
- Conditions
- Thymic Carcinoma
- 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 group | Role | What they receive |
|---|---|---|
| Milciclib Maleate (PHA-848125AC) | Experimental | 100 and 50 mg Capsule 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 Receives: Drug: Milciclib Maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Confirmed 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 to a maximum duration of 242 weeks or until PD.
Disease Control Rate
Point and 95% confidence interval estimates was calculated for the disease control rate (confirmed CRs / PRs and SD>/= 6 weeks). The analysis was performed in the evaluable populations.
Measured: Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.
Progression-free Survival
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 to a maximum duration of 242 weeks or until PD.
Duration of Response
Assessed 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 to a maximum duration of 242 weeks or until PD.
Overall Survival
The length of time from the start of treatment for a disease, such as cancer, to the date in which the patients diagnosed with the disease were still 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.
Overall Safety Profile (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 was 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 dose of study drug; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a total of 135 two-week cycles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study start22 Feb 2010
- Primary completion31 May 2017
- Study completion17 Dec 2018
Why it stopped: For the 2 last patients still on treated nominal therapeutic use of the Milciclib was approved at INT Milano.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thymic CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiziana Life Sciences LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glen Weiss, MD, Principal investigator, Scottsdale Clinical Research Institute, USABenjamin Besse, MD, Principal investigator, Institut Gustave Roussy, Villejuif, FranceJulien Mazières, MD, Principal investigator, Hopital Larrey CHU, Toulouse, FranceSilvia Novello, MD, Principal investigator, Ospedale San Luigi Gonzaga, Orbassano, ItalyArun Rajan, MD., Principal investigator, National Cancer Institute (NCI)Marina C Garassino, MD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011439
- Sponsor's protocol ID
- CDKO-125a-006
- Other IDs
- 2009-014338-79, 2009
- Status last verified
- Jan 2019
- First submitted
- 10 Nov 2009
- Last updated
- 6 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Of Oral PHA-848125AC In Patients With Thymic Carcinoma Previously Treated With Chemotherapy
- ClinicalTrials.gov ID
- NCT01011439
- Acronym / sponsor ID
- CDKO-125a-006
- Conditions
- Thymic Carcinoma
- Keywords
- B3 and C malignant thymoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For the 2 last patients still on treated nominal therapeutic use of the Milciclib was approved at INT Milano.
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Tiziana Life Sciences LTDIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2010 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Posted 16 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The intent of the study is to assess the antitumor activity of PHA-848125AC as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy.
Detailed description
The Simon's optimal 2 stage design is adopted for this single-arm, open-label, multicenter phase II clinical trial of PHA-848125AC administered to patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy (only one prior systemic therapy allowed). The intent of the study is to assess the antitumor activity of PHA-848125AC and ultimately to improve the outcome of patients with thymic carcinoma who have already exploited one chemotherapy option. The primary end point for this study is a progression free survival rate of 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Milciclib Maleate (PHA-848125AC) | Experimental | Drug: Milciclib Maleate100 and 50 mg Capsule 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically proven diagnosis of unresectable B3 thymoma or thymic carcinoma recurrent or progressing after prior chemotherapy (only one prior systemic therapy allowed)
- Presence of measurable disease
- Age >=18 years
- ECOG performance status 0-1
- Negative pregnancy test (if female in reproductive years)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milciclib MaleateAlso: PHA-848125AC150 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. | Drug | Milciclib Maleate (PHA-848125AC) |
Primary outcome
Progression-free Survival Rate at 3 Months
Time frame: 3 months since treatment start
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
6 secondary outcomes
Confirmed Objective Response Rate (ORR)
Time frame: Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.
Disease Control Rate
Time frame: Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.
Progression-free Survival
Time frame: Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.
Duration of Response
Time frame: Assessments were made every 6 weeks from start date until PD to a maximum duration of 242 weeks or until PD.
Overall Survival
Time frame: 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.
Overall Safety Profile (Adverse Events (NCI CTCAE) and Hematological and Blood Chemistry Parameters)
Time frame: Adverse events: from date treatment consent signed to 28 days after last dose of study drug; hematology/blood chemistry tests: at baseline and between Day 11-14 of each cycle of a total of 135 two-week cycles.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen Weiss, MD principal investigator
Scottsdale Clinical Research Institute, USA
Benjamin Besse, MD principal investigator
Institut Gustave Roussy, Villejuif, France
Julien Mazières, MD principal investigator
Hopital Larrey CHU, Toulouse, France
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Milciclib Maleate in people with Thymic Carcinoma, run by Tiziana Life Sciences LTD at 6 sites in 3 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 11 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 6 sites in United States, France, 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 16 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?
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.