AzTrials
AzTrials

LeukemiaPhase 2NCT00335868

PHA-739358 in Treating Patients With Chronic Myelogenous Leukemia That Relapsed After Imatinib Mesylate or c-ABL Therapy

A Phase 2 study testing danusertib, laboratory biomarker analysis and pharmacological study in people with Leukemia, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

RATIONALE: PHA-739358 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well PHA-739358 works in treating patients with chronic myelogenous leukemia that relapsed after imatinib mesylate or c-ABL therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
danusertib, laboratory biomarker analysis and pharmacological study
How many people
16 participants
Where
1 siteUnited States
Study dates
Mar 2007to Dec 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

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic myelogenous leukemia confirmed by bone marrow biopsy
  • Chronic, accelerated, or blastic phase disease
  • May have T315I mutation in BCR-ABL kinase
  • Relapsed after prior imatinib mesylate or c-ABL therapy
  • No CNS leukemia

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Blood pressure ≤ 140/90 mm Hg (with or without hypertension treatment for ≥ 1 week)
  • Transaminases ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • No known history of HIV infection
  • No active uncontrolled infection
  • No grade 3 or 4 bleeding
  • LVEF ≥ 45% by MUGA or ≥ 40% by transthoracic echocardiography
  • No medical or psychiatric condition or laboratory abnormalities that would limit study compliance or increase risk during study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 90 (female) or 180 (male) days after completion of study treatment
  • No significant cardiovascular disease (i.e., uncontrolled arrhythmias or unstable angina) within the past 6 months
  • No major thromboembolic event within the past 6 months, including any of the following:
  • Myocardial infarction
  • Stroke
  • Transient ischemic attack
  • Pulmonary embolism
  • Noncatheter-related deep-vein thrombosis

PRIOR CONCURRENT THERAPY:

  • Recovered from all acute toxic effects (excluding alopecia) of prior therapy
  • More than 2 weeks since prior chemoimmunotherapy
  • Hydroxyurea must be discontinued 1 day prior to study therapy
  • More than 4 weeks since prior major surgery
  • No other concurrent approved or investigational anticancer treatment, including chemotherapy, biologic response modifiers, hormones, or immunotherapy
  • No other concurrent investigational drugs
  • No concurrent participation in another treatment clinical trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

Official title: A Pilot Phase II Study of PHA-739358 in Patients With Chronic Myeloid Leukemia Relapsing on Gleevec or c-ABL Therapy

RATIONALE: PHA-739358 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well PHA-739358 works in treating patients with chronic myelogenous leukemia that relapsed after imatinib mesylate or c-ABL therapy.

Read the detailed description

OBJECTIVES:

  • Explore the clinical efficacy of PHA-739358, in terms of hematological response lasting ≥ 4 weeks, in patients with chronic myelogenous leukemia that relapsed after imatinib mesylate or c-ABL therapy.
  • Explore the safety profile of this drug in these patients.
  • Explore the pharmacokinetic profile of this drug and its N-oxide metabolite PHA-816359 in plasma.
  • Explore the modulation of histone H3 and CRKL phosphorylation after PHA-739358 administration.
  • Explore the relationship between plasma drug levels and the modulation of histone H3 and CRKL phosphorylation.
  • Explore the clinical efficacy of this drug, in terms of cytogenetic response in bone marrow.
  • Explore response depending on status of T315I mutation in BCR-ABL kinase.

OUTLINE: This is a pilot, open-label, multicenter study.

Patients receive PHA-739358 IV over 6 hours on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients benefitting from treatment may receive additional courses at the discretion of the investigator.

Patients undergo blood collection and bone marrow biopsies periodically for pharmacologic and biomarker correlative studies.

After completion of study treatment, patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 16 patients will be accrued for this study.

Conditions
Leukemia
Being tested
danusertib, laboratory biomarker analysis, pharmacological study
Keywords
accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, relapsing chronic myelogenous leukemia
Medical subject headings
Leukemia, Leukemia, Myeloid, Accelerated Phase, Blast Crisis, Leukemia, Myeloid, Chronic-Phase

What participants receive

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

What is being measured

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

  1. Antileukemic response in terms of complete hematological response, no evidence of leukemia, or return to chronic phase

  2. Overall safety profile of PHA-739358 by type, severity, timing, and relatedness of adverse events and laboratory abnormalities

  3. Pharmacokinetics of this drug and its N-oxide metabolite PHA-816359 by measuring their plasma concentration at different times after dosing

  4. Changes in histone H3 and CRKL phosphorylation

  5. Correlation between changes in degree of histone H3 and CRKL phosphorylation and concurrent PHA-739358 concentrations and/or hematological response

  6. Complete, partial, or minor cytogenetic response in bone marrow

Timeline

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

  1. First posted12 Jun 2006 (estimated)
  2. Study startMar 2007
  3. Primary completionDec 2009 (estimated)

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
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00335868
Sponsor's protocol ID
CDR0000486219
Other IDs
UCLA-0601009-01, NERVIANO-AURA-6202-005
Status last verified
Jul 2009
First submitted
8 Jun 2006
Last updated
18 Dec 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing danusertib, laboratory biomarker analysis and pharmacological study in people with Leukemia, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

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?

Antileukemic response in terms of complete hematological response, no evidence of leukemia, or return to chronic phase. The study lists 6 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 NCT00335868.

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 18 Dec 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in