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Myelodysplastic SyndromePhase 1/2NCT01085838

Erlotinib in Higher Risk Myelodysplastic Syndrome

A Phase 1/2 study testing Erlotinib in people with Myelodysplastic Syndrome, run by Groupe Francophone des Myelodysplasies at 14 sites in France.

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 aim of this study is to evaluate the toxicity and therapeutic efficacy of erlotinib in high-risk myelodysplastic syndrome (MDS) patients (with at least 10% of bone marrow blasts) ineligible for or having failed intensive chemotherapy and ineligible or after failure of treatment with a hypomethylating agent. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndrome
What is being tested?
Erlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
14 sitesFrance
Study dates
Jul 2010to Mar 2014
Phase
Phase 1/2
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

  • Diagnosis of MDS according to the WHO classification, but also including RAEB in transformation as defined by the FAB classification (that is patients with up to 30% of blasts in the bone marrow), with the exception of patients with preceding myeloproliferative syndrome or LMMC;
  • Higher-risk MDS as defined by a IPSS score >1 (IPSS: Int-2 or High);
  • Life expectancy > 3 months;
  • Percentage of bone marrow blasts >10 and below 30%;
  • Ineligible for or having failed intensive chemotherapy and ineligible for or having failed previous therapy with a hypomethylating agent;
  • Age ≥ 18 years;
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  • Written informed consent;
  • Patient must understand and voluntarily sign consent form;
  • Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements;
  • ECOG performance status between 0-2 at the time of screening;
  • Females of childbearing potential (defined as a sexually mature woman who has not undergone a hysterectomy or who is not naturally postmenopausal for at least 24 consecutive months, that is who has had menses at any time during the preceding 24 consecutive months) have to have a negative pregnancy test;
  • Adequate contraceptive methods should be carried out by all patients during therapy and for at least 2 weeks after completing therapy.
  • No existing contra-indication to treatment with erlotinib.
  • Health insurance.

Who cannot join

  • Serum creatinine ≥ 1.5 x the upper limit of normal, or creatinine clearance ≤60 mL/min.
  • Concomitant treatment with NSAIDS, warfarin, omeprazole, ranitidine or inducers (i.e. rifampicin, phenytoin; carbamazepin) or inhibitors (i.e. ketoconazole, ciprofloxacin, clarithromycin, voriconazole) of CYP3A4;
  • Inadequate liver function as defined by a serum bilirubin ≥ 1.5 x the upper limit of normal (except in the case of confirmed moderate unconjugated hyperbilirubinemia due to intramedullary hemolysis, as observed frequently in MDS), and/or ASAT/ALAT/GGT levels ≥2 x the upper limit of normal;
  • Known HIV-positivity;
  • Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the study;
  • Vitamine B12 or folate deficiency;
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  • Pregnant or lactating females;
  • Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within the 28 days preceding study entry;
  • Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast), unless the subject has been disease-free for ≥3 years;
  • Patients with a history of corneal disorders or another active ophthalmic disorder, active infections or other concomitant serious and uncontrolled medical conditions.
  • History of interstitial lung disease or any active pulmonary disease.
  • Patients with a history of myeloproliferative syndrome or LMMC

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • CHU d'Angers

    Angers, 49033

  • Hôpital Avicenne

    Bobigny, 93009

  • Centre Hospitalier du Mans

    Le Mans, 72037

  • CHRU Huriez

    Lille, 59037

  • CHRU de Limoges

    Limoges, 87046

  • Centre Hospitalier Lyon Sud

    Lyon, 69495

  • Institut Paoli-Calmettes

    Marseille, 13273

  • CHU Nantes

    Nantes, 44093

  • CHU Caremeau

    Nîmes, 30029

  • Hopital St Louis

    Paris, 75475

  • Hopital Cochin

    Paris, 75679

  • Hopital Purpan-Medecine interne

    Toulouse, 31059

  • Hopital Purpan

    Toulouse

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: Phase I-II Trial of Erlotinib in Higher Risk Myelodysplastic Syndrome

The aim of this study is to evaluate the toxicity and therapeutic efficacy of erlotinib in high-risk myelodysplastic syndrome (MDS) patients (with at least 10% of bone marrow blasts) ineligible for or having failed intensive chemotherapy and ineligible or after failure of treatment with a hypomethylating agent.

Read the detailed description

This is a phase I-II multicenter, open label, sequential cohort dose escalation study of erlotinib designed to assess the safety and efficacy of a daily administration of erlotinib in high risk MDS patients.

Five patients per cohort will be enrolled into sequential cohorts receiving increasing dosages of erlotinib. The first cohort of 5 patients will start with a dosage of 100 mg erlotinib daily. Response will be determined after 12 weeks of treatment (or earlier upon major hematologic improvement, whichever event occurs first). At the completion of each cohort, defined as the fifth subject completing the week 12 visit, the safety review panel will be responsible for making the decision as to whether the next cohort will begin, an intermediate dose cohort will be added, or if additional subjects will be enrolled into an earlier dose cohort.

Upon agreement of the safety review panel, the second cohort of patients will receive 150 mg of erlotinib daily, and - upon agreement of the safety review panel - the third cohort of five patients will be enrolled to receive 300 mg of erlotinib daily.

Since it is to be expected that the therapeutically required dosage of erlotinib is higher than the dosage for which a patient was initially enrolled (i.e. patient enrolled in the first cohort receiving 100 mg daily), dosage of erlotinib should be increased (for the same patient) to the next higher level, if no response is documented after 12 weeks of continuous treatment and no grade III or IV toxicity is documented. In contrast, responders will continue their treatment with the same dosage of erlotinib until grade III or IV toxicity arises or treatment loses efficacy (as defined by relapse/progression of the disease).

Consequently, this study plans to enrol 15 patients in 3 cohorts of 5 patients. Once the dose limiting toxicity has been defined, additional confirmatory subjects (20) will be enrolled into the appropriate lower dose as recommended by the safety review panel.

Being tested
Erlotinib
Keywords
Erlotinib, myelodysplastic syndrome
Medical subject headings
Myelodysplastic Syndromes

What participants receive

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

  • ErlotinibDrug

    Also called OSI-774

    Erlotinib oral capsule, 100, 150, or 300 mg/day during 12 weeks at study start

Study groups in NCT01085838
Study groupRoleWhat they receive
Cohort 1ExperimentalThe first cohort of 5 patients will start with a dosage of 100 mg erlotinib daily
Receives: Drug: Erlotinib
Cohort 2ExperimentalThe second cohort of patients will receive 150 mg of erlotinib daily
Receives: Drug: Erlotinib
Cohort 3ExperimentalThe third cohort of five patients will be enrolled to receive 300 mg of erlotinib daily
Receives: Drug: Erlotinib

What is being measured

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

  1. The primary objective is to estimate the overall response rate (CR, PR, mCR The primary objective is to estimate the overall response rate (CR, PR, mCR and HI according to the IWG 2000 and 2006 criteria) in patients treated with erlotinib.

    Measured: After 12 weeks treatment

Secondary outcomes (4)

  1. ·assessment of response duration

    Measured: While patient is on study/during follow-up.

  2. · survival

    Measured: While patient is on study/during follow-up.

  3. · treatment-related toxicity;

    Measured: While patient is on study/during follow-up.

  4. · correlation of prognostic parameters, response and survival, with the assessed biological parameters;

    Measured: While patient is on study/during follow-up.

Timeline

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

  1. First posted12 Mar 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionMar 2014
  4. Study completionMar 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01085838
Sponsor's protocol ID
GFM-ERLOTINIB-08
Status last verified
Mar 2013
First submitted
11 Mar 2010
Last updated
8 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Erlotinib in people with Myelodysplastic Syndrome, run by Groupe Francophone des Myelodysplasies at 14 sites in France.

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 14 inclusion and 12 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 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. 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 combined 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.

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?

The primary objective is to estimate the overall response rate (CR, PR, mCR The primary objective is to estimate the overall response rate (CR, PR, mCR and HI according to the IWG 2000 and 2006 criteria) in patients treated with erlotinib. (time frame: After 12 weeks treatment). 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 NCT01085838.

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 Nov 2016.

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