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Solid TumorsPhase 1NCT01129349

Phase 1 Study of Oprozomib Administered Orally in Patients With Advanced Refractory or Recurrent Solid Tumors

A Phase 1 study testing Oprozomib in people with Solid Tumors, run by Amgen at 3 sites 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

To evaluate the safety and tolerability of Oprozomib in patients with advanced refractory or recurrent solid tumors including determination of its Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) To determine the pharmacokinetics (PK) of Oprozomib To explore the anti-tumor activity of Oprozomib in this… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
Oprozomib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
3 sitesUnited States
Study dates
Apr 2010to Mar 2013
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

  • Disease Related
  • Histologically confirmed advanced solid tumor that is refractory or recurrent after standard treatments.
  • At least one site of radiographically measurable disease of ≥ 2 cm in the largest dimension by traditional computed tomography (CT) scanning technique or ≥ 1 cm in the largest dimension by spiral CT scanning (per RECIST criteria); or if, in the Principal Investigator's opinion, evaluable disease can be reliably and consistently followed, the patient may be eligible upon approval by the Onyx Therapeutics, Inc., Medical Monitor.
  • Demographic
  • Males and females ≥ 18 years of age
  • Life expectancy of more than three months
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  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Laboratory
  • Adequate hepatic function, with bilirubin ≤ 1.5 times the upper limit of normal (ULN), and alanine aminotransferase (ALT) ≤ 3 times ULN or ≤ 5 times ULN in the presence of hepatic tumor involvement
  • Absolute neutrophil count (ANC) ≥ 1500/mm3, hemoglobin ≥ 8 g/dL, and platelet count ≥ 100,000/ mm3
  • Screening platelet count must be independent of platelet transfusions for at least one week
  • Screening ANC must be independent of granulocyte- and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least one week and of pegylated G-CSF for at least two weeks
  • Patients may receive red blood cell (RBC) transfusions or receive supportive care with erythropoietin or darbepoetin in accordance with institutional guidelines
  • Calculated or measured creatinine clearance of ≥ 30 mL/min; calculation using a generally accepted formula such as that of Cockcroft and Gault: CrCl = [(140 - Age) × Mass (kg) / (72 × Creatinine mg/dL)], multiply by 0.85 if female
  • Ethical / Other
  • Written informed consent in accordance with federal, local, and institutional guidelines
  • Female patients of childbearing potential must have a negative serum or urine pregnancy test within three days of the first dose and agree to use dual methods of contraception during the study and for one month following the last dose of study drug. Post-menopausal females (> 45 years old and without menses for > 1 year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception during the study and for one month following the last dose if sexually active with a female of childbearing potential.

Who cannot join

  • Disease Related
  • Chemotherapy with approved or investigational anticancer therapeutics, including steroid therapy, within four weeks prior to first dose of Oprozomib or six weeks for antibody therapy
  • Radiation therapy or immunotherapy within three weeks prior to first dose; localized radiation therapy within one week prior to first dose Patients with brain metastases (patients with prior brain metastases are permitted, but must have completed treatment and have no evidence of active CNS disease for at least three months prior to first dose)
  • Prior treatment with a proteasome inhibitor
  • Concurrent Conditions
  • Major surgery within three weeks prior to first dose
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  • Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, or conduction abnormalities. Conduction system abnormalities not clinically warranting intervention are allowed.
  • Myocardial infarction within three months prior to first dose
  • Active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first dose
  • HIV infection (HIV seropositive)
  • Active hepatitis A, B, or C infection
  • Peripheral neuropathy of Grade ≥ 3 or Grade 2 with pain at the time of the first dose
  • Patients with pleural effusions requiring repeat thoracentesis or ascites requiring repeat paracentesis
  • Prior Oprozomib therapy
  • Hypersensitivity to Oprozomib or any of its components
  • Ethical / Other
  • Female patients who are pregnant or lactating
  • Psychiatric or medical conditions that in the opinion of the Investigator could interfere with treatment

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Sarah Cannon Research Institute

    Nashville, Tennessee

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229

  • Oncology Research Associates

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Phase 1, Open-label, Dose Escalation Study of Oprozomib Administered Orally in Patients With Advanced Refractory or Recurrent Solid Tumors

To evaluate the safety and tolerability of Oprozomib in patients with advanced refractory or recurrent solid tumors including determination of its Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) To determine the pharmacokinetics (PK) of Oprozomib To explore the anti-tumor activity of Oprozomib in this patient population including the overall response rate (ORR), the duration of responses (DOR), the progression-free survival (PFS) and time to progression (TTP) To define the pharmacodynamics (PDn) of Oprozomib.

Read the detailed description

This is a Phase 1, open label, dose-escalation study to determine the safety, MTD, and PK/PDn of Oprozomib when administered orally (PO) on Days 1, 2, 3, 4, and 5 of a 14 day cycle in patients with advanced refractory or recurrent solid tumor malignancies for which standard curative measures do not exist or are no longer effective.

Conditions
Solid Tumors
Being tested
Oprozomib
Keywords
Solid Tumors

What participants receive

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

  • OprozomibDrug

    Oral administration of Oprozomib on Days 1-5 of a 14 day cycle

Study groups in NCT01129349
Study groupRoleWhat they receive
OprozomibExperimentalPhase I, Dose Escalation, Single Arm, Open Label
Receives: Drug: Oprozomib

What is being measured

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

  1. Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)

    • To evaluate the safety and tolerability of Oprozomib in patients with advanced refractory or recurrent solid tumors including determination of its Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)
    • To determine the pharmacokinetics (PK) of Oprozomib

    Measured: 31 months

Secondary outcomes (1)

  1. Overall response rate (ORR), duration of responses (DOR), progression-free survival (PFS), and time to progression (TTP)

    • To explore the anti-tumor activity of Oprozomib in this patient population including the overall response rate (ORR), the duration of responses (DOR), the progression-free survival (PFS) and time to progression (TTP)
    • To define the pharmacodynamics (PDn) of Oprozomib.

    Measured: 31 months

Timeline

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

  1. First posted24 May 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionNov 2012
  4. Study completionMar 2013

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
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01129349
Sponsor's protocol ID
2009-003
Status last verified
Apr 2017
First submitted
21 May 2010
Last updated
2 May 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oprozomib in people with Solid Tumors, run by Amgen at 3 sites 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 17 inclusion and 18 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 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) (time frame: 31 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 NCT01129349.

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 2 May 2017.

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