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Mantle Cell LymphomaPhase 2NCT00847223

Efficacy and Safety of the Farnesyl-transferase Inhibitor (Tipifarnib) in Mantle Cell Lymphoma

A Phase 2 study testing ZARNESTRA (Tipifarnib) in people with Mantle Cell Lymphoma, run by Lymphoma Study Association.

Terminated

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

Official record
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Trial summary

To determine the EFFICACY and the SAFETY PROFILE and TOXICITY of Zarnestra® in the treatment of patients with previously treated mantle cell lymphoma not appropriate for autologous bone marrow transplantation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
ZARNESTRA (Tipifarnib)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
No sites listed yet
Study dates
Jun 2007to Mar 2009
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

  • Male or female subject 18 years or older.
  • Initial diagnosis of histologically confirmed mantle cell lymphoma based on the World Health Organization 1997 classification.
  • Patient not able to receive high dose autologous stem cell transplantation with relapsed, refractory or progressive MCL after prior anti-neoplastic treatment. Relapse or progression since previous anti-neoplastic therapy must be documented by new lesions or objective evidence of progression of existing lesions. Biopsy is not required.
  • Ann Arbor stages I-IV.
  • At least 1 measurable lymph node mass that is >1.5 cm in 2 perpendicular dimensions, and has not been previously irradiated or has grown since previous irradiation.
  • Eastern Cooperative Oncology Group [ECOG] performance status 0-2.
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  • The following laboratory values at screening,:
  • Absolute neutrophil count (ANC) ≥ 1.0 G/L and Platelets ≥ 75 G/L
  • Aspartate transaminase (AST) ≤ 2.5 x ULN; Alanine transaminase (ALT) ≤ 2.5 x ULN; Total bilirubin ≤ 1.5 x ULN; Creatinin level ≤ 150 µmol/L
  • Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Women are neither breast feeding nor pregnant for the duration of the study. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. Male subject agrees to use an acceptable method for contraception for the duration of the study.
  • Voluntary signed informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Patient with minimum life expectancy of 3 months.

Who cannot join

  • Any other type of lymphoma.
  • Previous treatment with Zarnestra®.
  • Anti-neoplastic or radiation therapy within 2 weeks before Day 1 of Cycle 1.
  • Major surgery within 2 weeks before Day 1 of Cycle 1.
  • Rituximab, alemtuzumab (Mabcampath®), or other unconjugated therapeutic antibody within 2 weeks before Day 1 of Cycle 1
  • Nitrosoureas within 2 weeks before Day 1 of Cycle 1.
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  • Radioimmunoconjugates or toxin immunoconjugates such as ibritumomab tiuxetan (Zevalin™), or tositumomab (Bexxar®) within 4 weeks before Day 1 of Cycle 1.
  • Less than 30 days since participation in another investigational agent study on Day 1 of cycle 1. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.
  • Known or suspected allergy to imidazole drugs, such as clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, isoconazole, sulconazole, tioconazole, or terconazole.
  • Subjects not adequately recovered from any treatment-related non hematologic toxicity (recovery is defined as NCI CTC v3.0 Grade 0 or 1).
  • Symptomatic peripheral neuropathy of any grade.
  • Diagnosed or treated for a malignancy other than NHL within 5 years before Day 1 of Cycle 1, with the exception of complete resection of basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy. Subjects previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score ≤7, and a prostate specific antigen (PSA) ≤10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (ie, prostatectomy or radiotherapy) ≥2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy.
  • Active systemic infection requiring treatment.
  • Previously known HIV positive serology
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
  • Adult patient under guardian.

About this study

Official title: A Phase II Study Evaluating the Efficacy and Safety of the Farnesyl-transferase Inhibitor ZARNESTRA® in Patients With Relapsed, Refractory or Progressive Mantle Cell Lymphoma Not Appropriate for Autologous Bone Marrow Transplantation

To determine the EFFICACY and the SAFETY PROFILE and TOXICITY of Zarnestra® in the treatment of patients with previously treated mantle cell lymphoma not appropriate for autologous bone marrow transplantation. 27 evaluable subjects will be enrolled for an analysis in 2 stages (11 for the first stage, 16 for the second).

Patients who receive at least one dose of Zarnestra® and have at least one post-baseline response assessment of discontinued study frug for early progression are evaluable. Subjects not evaluable for response will be replaced, up to 35 patients.

Read the detailed description

Zarnestra® will be administered at 300 mg administered orally twice daily for the first 21 days of each 28-days cycle. Tipifarnib treatment stops no later than day 21 of each cycle.

Subjects will receive a total of 4 cycles of treatment. Two additional cycles might be administered for patients showing improvement to PR after 4 cycles.

After testing the drug on 11 patients in the first stage, the trial will be terminated if 1 or fewer respond and the drug will not be considered as effective.

If two or more patients respond in the first stage, the trial goes on to the second stage to include a total of 27 patients.

Being tested
ZARNESTRA (Tipifarnib)
Keywords
Mantle cell lymphoma, Lymphoma, relapsed, refractory or progressive MCL, Mantle cell lymphoma (relapsed, refractory or progressive)
Medical subject headings
Lymphoma, Mantle-Cell, Lymphoma, Recurrence

What participants receive

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

  • ZARNESTRA (Tipifarnib)Drug

Study groups in NCT00847223
Study groupRoleWhat they receive
ZARNESTRA (Tipifarnib)ExperimentalNot described
Receives: Drug: ZARNESTRA (Tipifarnib)

What is being measured

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

  1. Overall response rate (complete response [CR] + complete response unconfirmed [CRu] + partial response [PR])

    Percentage of patients in CR, CR uncertain or PR

    Measured: 4 months

Secondary outcomes (4)

  1. Overall CR rate (CR + CRu)

    percentage of patients in CR or CRu

    Measured: 2 years

  2. Progression-free survival (PFS)

    duration of survival without progression

    Measured: 2 years

  3. overall survival

    percentage of patients alive

    Measured: 2 years

  4. number of SAE

    Measured: 2 years

Timeline

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

  1. First posted19 Feb 2009 (estimated)
  2. Study startJun 2007
  3. Primary completionMar 2009
  4. Study completionMar 2009

Why it stopped: Inefficiency of treatment

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
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00847223
Sponsor's protocol ID
MCL06-1
Status last verified
Aug 2018
First submitted
18 Feb 2009
Last updated
23 Aug 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ZARNESTRA (Tipifarnib) in people with Mantle Cell Lymphoma, run by Lymphoma Study Association.

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 16 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 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

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 was stopped early (reason given: Inefficiency of treatment). Results are not available in the source record.

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?

Overall response rate (complete response [CR] + complete response unconfirmed [CRu] + partial response [PR]) (time frame: 4 months). 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 NCT00847223.

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 23 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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