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Metastatic Malignant NeoplasmPhase 1NCT02540876

Ilorasertib in Treating Patients With CDKN2A-deficient Advanced or Metastatic Solid Cancers That Cannot Be Removed by Surgery

A Phase 1 study testing Ilorasertib and Laboratory Biomarker Analysis in people with Metastatic Malignant Neoplasm and Solid Neoplasm, run by University of Chicago at 1 site in United States.

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 pilot phase I trial studies how well ilorasertib works in treating patients with cyclin-dependent kinase inhibitor 2A (CDKN2A)-deficient solid cancers that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ilorasertib and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
8 Sep 2015to 8 Feb 2019
Phase
Phase 1
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

  • Eligible and consent to the Institutional Review Board (IRB) 13-0002 registry trial protocol
  • Subjects must have histologically confirmed solid malignancy that is metastatic or unresectable
  • The patient should have received all established therapies where there is a clear, superior available regimen available for the patient and the patient should have demonstrated progressive disease on or since completion of the last treatment regimen
  • Patients must have measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral CT scan
  • Patients must have prior CT scan images available for investigators to collect
  • Patients must have available tumor molecular profiling from Clinical Laboratory Improvement Amendments (CLIA)-certified labs or have available archived tissue to be sent to such a laboratory in the context of this investigation
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  • Molecular testing in a CLIA-certified laboratory must have demonstrated a deletion involving the CDKN2A locus or a mutation within the locus that can be deemed from best available evidence to be likely to cause inactivation of a gene within or protein encoded by CDKN2A; sequencing or fluorescence in situ hybridization (FISH)/chromogenic in situ hybridization (CISH) methods are acceptable; the investigators will consider analyses performed according to similar standards as applied by Foundation Medicine (likely to be the most common source of molecular diagnostic data for patients in this trial)
  • At least 3 weeks must have passed since any prior anti-tumor therapies including chemotherapy, radiation therapy or any other anti-cancer treatments
  • Serum creatinine value of < 1.5 times the upper limit of normal (ULN) and either an estimated creatinine clearance value of > 50 mL/min as determined by the Chronic Kidney Disease Epidemiology (CKD EPI) or MDRD (Modification of Diet in Renal Disease) formulae or a creatinine clearance value of > 50 mL/min based on a 24 hour urine collection
  • Subject has adequate liver function as demonstrated by serum bilirubin < 2 x ULN and Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN. For subjects with liver metastasis, adequate liver function is demonstrated by serum bilirubin =< 2 x ULN and AST/ALT =< 5.0 x ULN
  • Subject has adequate bone marrow as demonstrated by absolute neutrophil count (ANC) >= 1,500/mm^3 (1.5 x 10^9/L); platelets >= 100,000/mm^2 (100 x 10^9/L); hemoglobin >= 9.0 g/dL (1.4 mmol/L)
  • Subject has QTc interval < 500 msec on baseline electrocardiogram
  • Subject has blood pressure controlled to < 150 mmHg systolic and < 95 mmHg diastolic at screening
  • Subject has a documented left ventricular ejection fraction > 50%
  • Women of child-bearing potential and men must agree to use adequate contraception (one of the following listed below) prior to the study entry, for the duration of study participation and up to 3 months following completion of therapy; women of child-bearing potential must have a negative pregnancy test within 7 days prior to initiation of treatment and post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
  • Acceptable contraception
  • Total abstinence from sexual intercourse (minimum one complete menstrual cycle)
  • Vasectomized male subjects or vasectomized partner of female subjects
  • Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
  • Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and for 3 months following completion of therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status: 0-1
  • Patients must be able to provide written informed consent

Who cannot join

  • Patients with hospitalization within 4 weeks of treatment initiation date for co-morbid conditions or any complication of disease or therapy that is deemed by the principal investigator as unstable or incompletely treated
  • Patients with any psychiatric or social condition that leads them to be unlikely to adhere to the study schedule and contribute to the primary objectives
  • Women that are pregnant or lactating are excluded from this study
  • Subject has known active central nervous system (CNS) involvement; the subject has untreated brain or meningeal metastases; CT scans are not required to rule out brain or meningeal metastases unless there is a clinical suspicion of central nervous system disease; subjects with treated brain metastases that are radiographically or clinically stable for at least 4 weeks after therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are eligible, providing that they are asymptomatic, and do not require corticosteroids (must have discontinued steroids at least 1 week prior to study drug administration)
  • Subject has had major surgery within 28 days prior to study day 1
  • Subject has proteinuria defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version [v] 4.0) grade > 1 at baseline as measured by a urine dipstick (2+ or greater) and confirmed by a 24 hour urine collection (>= 1 g/24 hrs); subjects may be re-screened if proteinuria is shown to be controlled with or without intervention
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  • Subject is taking any oral anticoagulant
  • History of:
  • Symptomatic congestive heart failure
  • Unstable angina pectoris or cardiac arrhythmia (subjects with stable atrial fibrillation are not excluded)
  • Adrenal insufficiency
  • Subject is unable to swallow or absorb oral tablets normally
  • Subject takes cytochrome P450, family 3, subfamily A (CYP3A) inhibitors within 3 days or inducers within 7 days prior to the study drug administration; any questions or clarifications of these determinations should be brought to the attention of the principal investigator (PI); the PI will make the final determination on when it is safe to initiate ABT-348 (ilorasertib) therapy under circumstances where the magnitude or relevance of possible CYP3A4 inhibitors/inducers is unclear in the protocol appendix

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: A Pilot Study for Ilorasertib (ABT-348) in Patients With CDKN2A-deficient Advanced Solid Cancers: A Series of Individual Patient Cross-Over Studies With Growth Trajectory Assessment

This pilot phase I trial studies how well ilorasertib works in treating patients with cyclin-dependent kinase inhibitor 2A (CDKN2A)-deficient solid cancers that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery. Ilorasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Being tested
Ilorasertib, Laboratory Biomarker Analysis
Medical subject headings
Neoplasm Metastasis

What participants receive

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

  • IlorasertibDrug

    Also called A-968660.0, ABT-348

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT02540876
Study groupRoleWhat they receive
Treatment (ilorasertib)ExperimentalPatients receive ilorasertib PO BID on days 1, 8, 15, 29, and 36. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Ilorasertib; Other: Laboratory Biomarker Analysis

What is being measured

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

  1. Change in tumor burden.

    Change in tumor measurements from baselines through end of study.

    Measured: 22 weeks

Secondary outcomes (1)

  1. Number of patients with response as per Response Evaluation Criteria in Solid Tumors (RECIST).

    The number of patients with RECIST response will be estimated at week 12.

    Measured: Up to week 12

Timeline

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

  1. First posted4 Sep 2015 (estimated)
  2. Study start8 Sep 2015
  3. Primary completion8 Feb 2019
  4. Study completion8 Feb 2019

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02540876
Sponsor's protocol ID
IRB15-0083
Other IDs
NCI-2015-01328, AbbVie IIS-10750, IRB15-0083, P30CA014599
Status last verified
Apr 2019
First submitted
27 Aug 2015
Last updated
22 Apr 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ilorasertib and Laboratory Biomarker Analysis in people with Metastatic Malignant Neoplasm and Solid Neoplasm, run by University of Chicago 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?

The sponsor lists 22 inclusion and 13 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 22 Apr 2019. 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 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.

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?

Change in tumor burden. (time frame: 22 weeks). 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 NCT02540876.

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 22 Apr 2019.

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