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Primary MyelofibrosisPhase 2NCT01236638

Extension Study Evaluating the Long Term Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET)

A Phase 2 study testing Momelotinib in people with Primary Myelofibrosis and Post-Polycythemia Vera Myelofibrosis, run by Sierra Oncology LLC - a GSK company at 6 sites in 3 countries.

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 extension protocol to the core study CCL09101 allows patients who have tolerated the drug and derived a clinical benefit, to continue to receive treatment beyond the 9 cycles of the core protocol. Long term safety and efficacy of CYT387 (momelotinib) will be evaluated. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Momelotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
6 sitesin 3 countries
Study dates
Nov 2010to Jun 2014
Phase
Phase 2
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 completed at least 9 cycles of treatment on the core study 'A Phase I/II, Open-Label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally-Administered CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (CCL09101)' and achieved stable disease (SD), clinical improvement (CI), partial remission (PR) or complete remission (CR) using the International Working Group consensus criteria for treatment responses in myelofibrosis with myeloid metaplasia (IWG-MRT; Tefferi et al., 2006)
  • Must be able to provide informed consent and be willing to sign an informed consent form.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  • Must have evidence of acceptable organ function within 7 days of initiating study drug as evidenced by the following:
  • SGOT (AST) or SGPT (ALT) <= 2.5 x upper limit of normal (ULN) (or <= 5 x ULN if in the investigator's opinion the elevation is due to extramedullary hematopoiesis)
  • Bilirubin <= 2.0 x ULN or direct bilirubin < 1.0
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  • Serum creatinine <= 2.5 x ULN
  • Absolute neutrophil count >= 500/µL
  • Platelet count >= to 20,000/µL
  • Females of childbearing potential must have a negative pregnancy test within 4 days of entering the extension protocol.

Who cannot join

  • A delay of 4 weeks or more since the last preceding dose of CYT387 on the CCL09101 core study.
  • Any chemotherapy (e.g., hydroxyurea), immunomodulatory drug therapy (e.g., thalidomide), immunosuppressive therapy, corticosteroids > 10 mg/day prednisone or equivalent, or growth factor treatment (e.g., erythropoietin) within 14 days prior to initiation of study drug.
  • Incomplete recovery from major surgery within four weeks of study entry.
  • Radiation therapy within four weeks of study entry.
  • Women of childbearing potential, unless surgically sterile for at least 3 months (i.e., hysterectomy), OR postmenopausal for at least 12 months (FSH > 30 U/mL), OR unless they agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through end of study. Permitted methods for preventing pregnancy must be communicated to study subjects and their understanding confirmed.
  • Men who partner with a woman of childbearing potential, unless they agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through to the end of study. Permitted methods for preventing pregnancy must be communicated to study subjects and their understanding confirmed.
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  • Females who are pregnant or are currently breastfeeding.
  • Known positive status for HIV.
  • Clinically active hepatitis B or C.
  • Diagnosis of another malignancy unless free of disease for at least three years following therapy with curative intent. Patients with early-stage basal cell or squamous cell skin cancer, cervical intraepithelial neoplasia, cervical carcinoma in situ or superficial bladder cancer may be eligible to participate at the Investigator's discretion.
  • Any acute active infection.
  • Cardiac dysrhythmias requiring treatment, or prolongation of the QTc (Fridericia) interval to >450 msec for males or >470 msec for females at pre-study screening, unless attributable to pre-existing bundle branch block.
  • Presence of >= Grade 2 peripheral neuropathy.
  • Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), uncontrolled or unstable angina, myocardial infarction, cerebrovascular accident, or pulmonary embolism within 3 months prior to initiation of study drug.
  • Uncontrolled inter current illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

United States3 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Stanford Cancer Center

    Stanford, California, 94305-5821

Other trials in United States

Canada2 sites

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Australia1 site

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

About this study

Official title: A Phase II, Open-Label Extension Study Evaluating the Long Term Safety, Tolerability & Efficacy of Orally-Administered CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis

This extension protocol to the core study CCL09101 allows patients who have tolerated the drug and derived a clinical benefit, to continue to receive treatment beyond the 9 cycles of the core protocol. Long term safety and efficacy of CYT387 (momelotinib) will be evaluated.

Read the detailed description

The myeloproliferative neoplasms (MPN), most notably polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF) are a diverse but inter-related suite of clonal disorders of pluripotent hematopoietic stem cells (Tefferi et al., 2008). The MPN share a range of biological, pathological, and clinical features including the relative overproduction of one or more cells of myeloid origin, growth factor independent colony formation in vitro, marrow hypercellularity, extramedullary hematopoiesis, spleno- and hepatomegaly, and thrombotic and/or hemorrhagic diatheses (Tefferi et al., 2005).

This is a multi centre, open-label, extension study of the core study (CCL09101). The primary aims of the study will be to determine the long term safety and tolerability of orally-administered CYT387 when administered as a capsule dose, on a 28-day treatment cycle.

Following completion of the core study (CCL09101), patients who have tolerated the drug and derived clinical benefit will continue to be treated with CYT387 administered orally.

Subjects will be evaluated every three months for up to 24 cycles of CYT387 treatment. Subjects will return for a follow-up visit 30 days after completion of the last dose of study drug.

Being tested
Momelotinib
Keywords
Primary Myelofibrosis, Post-Polycythemia Vera, Post-Essential Thrombocythemia, CYT387 (momelotinib)
Medical subject headings
Primary Myelofibrosis

What participants receive

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

  • MomelotinibDrug

    Also called CYT387

    Patients will continue receiving the same doses as assigned during the CCL09101 protocol; up to 400 mg once per day (QD). CYT387 will be administered orally as a single daily dose (at least 20 and no more than 28 hours apart, preferably in a fasted state at least two hours before and one hour after a meal), except for patients on the twice daily (BID) dosing regime (150 mg BID).

Study groups in NCT01236638
Study groupRoleWhat they receive
MomelotinibExperimentalNot described
Receives: Drug: Momelotinib

What is being measured

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

  1. To determine the long term safety and tolerability of orally-administered CYT387 in patients with PMF or post-ET/PV MF following completion of core study CCL09101

    Measured: Safety monitoring will be undertaken for all patients every 3 months

  2. To obtain information on the long term effectiveness of orally-administered CYT387 in patients with PMF or post-ET/PV MF

    Measured by complete response (CR) rate, partial response (PR) rate and clinical improvement (CI) rate according to IWG-MRT consensus criteria

    Measured: Every three months

Timeline

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

  1. First posted8 Nov 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionJun 2014
  4. Study completionJun 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01236638
Sponsor's protocol ID
CCL09101E
Status last verified
Jan 2019
First submitted
5 Nov 2010
Last updated
4 Feb 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Momelotinib in people with Primary Myelofibrosis and Post-Polycythemia Vera Myelofibrosis, run by Sierra Oncology LLC - a GSK company 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 10 inclusion and 15 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 4 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, Canada, Australia. 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?

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?

To determine the long term safety and tolerability of orally-administered CYT387 in patients with PMF or post-ET/PV MF following completion of core study CCL09101 (time frame: Safety monitoring will be undertaken for all patients every 3 months). The study lists 2 primary outcomes in all. 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 NCT01236638.

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 4 Feb 2019.

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