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Advanced Malignant Solid TumorsPhase 1NCT00768469

Study Evaluating Safety And Tolerability, Solid Tumor

A Phase 1 study testing Neratinib and Paclitaxel in people with Advanced Malignant Solid Tumors, run by Puma Biotechnology, Inc. at 2 sites in Japan.

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 is an open-label, phase 1 study of ascending multiple oral doses of HKI-272 in combination with paclitaxel. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Advanced Malignant Solid Tumors
What is being tested?
Neratinib and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesJapan
Study dates
Oct 2008to Jan 2011
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have confirmed pathologic diagnosis of a solid tumor that is not curable with available therapy for which HKI-272 plus paclitaxel is a reasonable treatment option.
  • At least 1 measurable lesion as defined by RECIST criteria.
  • Eastern Cooperative Oncology Group (ECOG) 0 to 1
  • LVEF within institutional limits of normal (by MUGA or ECHO).
  • Screening laboratory values within the following parameters:
  • ANC: greater than or equal to 1.5 x 10E9 /L (1,500 /mm3)
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  • Platelet count: 10 x 10E10 /L (100,000 /mm3)
  • Hemoglobin: greater than or equal to 9.0 g/dL
  • Serum creatinine: less than or equal to 1.5 x upper limit of normal (ULN)
  • Total bilirubin: less than or equal to 1.5 xULN · AST and ALT: less than or equal to 2.5 xULN (less than or equal to 5 x ULN if liver metastases are present)
  • For women of child bearing potential, a negative urine or serum pregnancy test result before study entry. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or other means of birth control or whose sexual partners are either sterile or using contraceptives.
  • All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 28 days after the last dose of test article.

Who cannot join

  • Prior treatment with anthracyclines with a cumulative dose of doxorubicin of greater than 400 mg/m^2, epirubicin dose of greater than 800 mg/m^2, or the equivalent dose for other anthracyclines or derivatives.
  • Major surgery, chemotherapy, radical (curative intent) radiotherapy, investigational agents, or other cancer therapy within 2 weeks of treatment day 1 or non-recovery from all clinically significant acute adverse effects of prior therapies (excluding alopecia).
  • Subjects with bone or skin as the only site of disease.
  • Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, and/or progressive growth (subjects with a history of CNS metastases or cord compression are allowable if they have been definitively treated and have been clinically stable for at least three months, and off steroids or anticonvulsants, before first dose of test article).
  • QTc interval greater than 0.47 second or known history of QTc prolongation or Torsade de Pointes (TdP).
  • Known hypersensitivity to paclitaxel or Cremophor EL (polyoxyethylated castor oil).
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  • Pregnant or breast feeding women.
  • Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade greater than or equal to 2 diarrhea of any etiology at baseline).
  • Inability or unwillingness to swallow the HKI-272.
  • Treatment with a taxane within 3 months of treatment day 1.
  • Pre-existing grade 2 or greater motor or sensory neuropathy.
  • Any other cancer within 5 years prior to screening with the exception of contralateral breast carcinoma, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin.
  • Presence of clinically significant or uncontrolled cardiac disease, including congestive heart failure (New York Heart Association [NYHA] functional classification of greater than or equal to 2), angina requiring treatment, myocardial infarction within the past 12 months, or any clinically significant supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention.
  • Evidence of significant medical illness or abnormal laboratory finding that would, in the investigator's judgment, make the subject inappropriate for this study. Examples include, but are not limited to, serious active infection (ie, requiring intravenous antibiotic or antiviral agent), uncontrolled major seizure disorder, or significant pulmonary disorder (e.g. interstitial pneumonitis, pulmonary hypertension).

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

  • Investigational Site

    Shizuoka

  • Investigational Site

    Tokyo

Other trials in Japan

About this study

Official title: A Phase 1 Study Of Neratinib (HKI-272) In Combination With Paclitaxel In Subjects With Solid Tumors

This is an open-label, phase 1 study of ascending multiple oral doses of HKI-272 in combination with paclitaxel.

Being tested
Neratinib, Paclitaxel
Keywords
HKI-272, Paclitaxel, Combination, Solid Tumor

What participants receive

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

  • NeratinibDrug

    Also called HKI-272

    Administered orally, continuous, once daily.

  • PaclitaxelDrug

    Administered IV, on days 1, 8, 15 of 28 day cycle.

Study groups in NCT00768469
Study groupRoleWhat they receive
Nera 160 + PacExperimentalNeratinib 160 mg + Paclitaxel 80 mg/m^2
Receives: Drug: Neratinib; Drug: Paclitaxel
Nera 240 + PacExperimentalNeratinib 240 mg + Paclitaxel 80 mg/m^2
Receives: Drug: Neratinib; Drug: Paclitaxel

What is being measured

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

  1. Dose Limiting Toxicity (DLT) - Percentage of Participants With DLT Events

    The incidence of DLTs in subjects with advanced solid tumors, treated with neratinib in combination with paclitaxel 80 mg/m^2. DLT was defined as any neratinib plus paclitaxel related Grade 3 or 4 nonhematologic toxicity or Grade 4 hematologic toxicity with few exceptions.

    Measured: From first dose day through day 28.

  2. Maximum Tolerated Dose

    The maximum tolerated dose of neratinib, as determined by the incidence of DLTs, in combination with paclitaxel 80 mg/m^2, in subjects with advanced solid tumors.

    Measured: From first dose day through day 28.

Secondary outcomes (3)

  1. Objective Response Rate

    Percentage of participants with partial response (PR) or complete response (CR) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.

    Measured: From first dose date to progression/death or last tumor assessment, up to 78 weeks.

  2. Progression Free Survival

    Number of weeks between the date of the first dose of test article and the first date of disease recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (v1.0), as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the nadir LD, meaning the smallest sum of the LDs recorded since the treatment started; or unequivocal progression of existing nontarget lesions; or the appearance of any new lesions.

    Measured: From first dose date to progression/death, up to 78 weeks.

  3. Duration of Response

    Number of weeks from the time at which measurement criteria are met for Complete Response (CR) or Partial Response (PR) (whichever status is recorded first) until the first date on which recurrence or progressive disease (PD) is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started, for responders only, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.

    Measured: From start date of response to first disease progression, up to 71 weeks.

Timeline

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

  1. First posted8 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionJan 2011
  4. Study completionJan 2011

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00768469
Sponsor's protocol ID
3144A2-1115 / B1891001
Status last verified
Apr 2018
First submitted
7 Oct 2008
Last updated
19 Nov 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Neratinib and Paclitaxel in people with Advanced Malignant Solid Tumors, run by Puma Biotechnology, Inc. at 2 sites in Japan.

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 14 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 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 19 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Dose Limiting Toxicity (DLT) - Percentage of Participants With DLT Events (time frame: From first dose day through day 28.). 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 NCT00768469.

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 19 Nov 2018.

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