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Advanced Solid TumorsPhase 1NCT00522652

Phase I Trial of PX-478

A Phase 1 study testing PX-478 in people with Advanced Solid Tumors and Lymphoma, run by Cascadian Therapeutics Inc. at 2 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

This study is being conducted to determine the safety and biologic activity of PX-478, and to allow for observation of any preliminary evidence of antitumor activity in patients with advanced metastatic cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors, Lymphoma
What is being tested?
PX-478
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesUnited States
Study dates
Aug 2007to May 2010
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

  • The patient has signed the informed consent and must be considered legally capable of providing his or her own consent for participation in this study.
  • The patient has a histologically or cytologically confirmed diagnosis of advanced solid tumor or lymphoma and has failed or is intolerant of standard therapy.
  • The patient is ≥18 years of age.
  • ECOG performance status 0 to 1.
  • The patient has a predicted life expectancy of at least 12 weeks.
  • Patients must have discontinued prior chemotherapy or other investigational agents for at least three weeks prior to receiving the first dose of study drug (six weeks for mitomycin C, nitrosureas, vaccines, or antibody therapy) and recovered from the toxic effects of that treatment (recovered to baseline or ≤Common Toxicity Criteria for Adverse Events (CTCAE) grade 1).
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  • Patients must have discontinued any radiation therapy at least four weeks prior to entry into the study and have recovered from all radiation-related toxicities (recovered to baseline or ≤CTCAE grade 1).
  • The patient has adequate hematologic function defined as: WBC count >3,000 cells/μL; platelets >100,000/μL; hemoglobin >9 g/dL (may be transfused to this level); ANC >1500 cells/μL.
  • The patient has adequate hepatic function defined as: bilirubin <1.5 mg/dL; aspartate aminotransaminase (AST/SGOT) \& alanine aminotransferase (ALT/SGPT) <2.5 x ULN or <5 x ULN if due to metastatic disease.
  • The patient has adequate renal function as defined by serum creatinine level <1.5 mg/dL.
  • Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method; abstinence) prior to study entry and for the duration of study participation. The patient, if a man, agrees to use effective contraception or abstinence.

Who cannot join

  • Patients with any active infection requiring i.v. antibiotics at study entry.
  • Any serious concomitant systemic disorders that in the opinion of the investigator would place the patient at excessive or unacceptable risk of toxicity.
  • Surgery within the four weeks prior to the first dose of PX 478.
  • Significant central nervous system (CNS) or psychiatric disorder(s) that preclude the ability of the patient to provide informed consent.
  • Known or suspected brain metastases that have not received adequate therapy. In the case of previously treated brain metastases, a minimum of four weeks interval between completion of radiation therapy and registration on study with radiologic evidence of stable or responding brain metastases is required. In the setting of previous CNS metastasectomy, adequate (minimum four week) recovery from surgery and/or radiation therapy should be documented.
  • Patients with a history of seizures, non-healing wounds, or arterial thrombosis.
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  • Patients with unstable atrial or ventricular arrhythmias requiring control by medication; any cardiac ischemic event experienced within the preceding six months; prior history of congestive heart failure requiring therapy.
  • Patients who are breastfeeding or pregnant (confirmed by serum β-HCG within 10 days prior to the start of study treatment if applicable).
  • Patients with total gastrectomy or partial bowel obstruction.
  • Any condition that could jeopardize the safety of the patient and compliance with the protocol.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • TGen Clinical Research Services at Scottsdale Healthcare

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Phase 1 Trial of Oral PX-478 (a HIF-1α Inhibitor) in Patients With Advanced Solid Tumors or Lymphoma

This study is being conducted to determine the safety and biologic activity of PX-478, and to allow for observation of any preliminary evidence of antitumor activity in patients with advanced metastatic cancer.

Being tested
PX-478
Keywords
cancer, advanced cancer, lymphoma
Medical subject headings
Lymphoma, Neoplasms

What participants receive

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

  • PX-478Drug

    Oral formulation, dose escalation, taken on days 1 to 5 of a 21 day cycle until progression or development of unacceptable toxicity

Study groups in NCT00522652
Study groupRoleWhat they receive
Investigational DrugExperimentalDose Escalation
Receives: Drug: PX-478

What is being measured

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

  1. To determine the MTD of PX-478 administered orally on days one to five of a 21 day cycle

    Measured: 21 days

Secondary outcomes (5)

  1. To evaluate the safety profile of PX-478 when administered orally on days one to five of a 21 day cycle

    Measured: 42 days

  2. To evaluate pharmacodynamic measures of the effects of PX 478 on the HIF 1-alpha pathway, and related tumor markers

    Measured: 42 days

  3. To determine the PK profile of PX 478 when administered orally on days one to five of a 21 day cycle

    Measured: 21 days

  4. To evaluate the effects of PX 478 on tumor blood flow and vascular permeability as measured by DCE MRI

    Measured: 21 days

  5. To evaluate the anti-tumor activity of PX 478 in patients with advanced malignancies

    Measured: 42 days

Timeline

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

  1. First posted30 Aug 2007 (estimated)
  2. Study startAug 2007
  3. Primary completionMay 2010
  4. Study completionMay 2010

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
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00522652
Sponsor's protocol ID
PX-478-001
Status last verified
May 2010
First submitted
28 Aug 2007
Last updated
17 May 2018
Results posted
No
Data monitoring committee
No

Publications

  • Palayoor ST, Mitchell JB, Cerna D, Degraff W, John-Aryankalayil M, Coleman CN. PX-478, an inhibitor of hypoxia-inducible factor-1alpha, enhances radiosensitivity of prostate carcinoma cells. Int J Cancer. 2008 Nov 15;123(10):2430-7. doi: 10.1002/ijc.23807.

    PubMed 18729192

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PX-478 in people with Advanced Solid Tumors and Lymphoma, run by Cascadian Therapeutics Inc. at 2 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 11 inclusion and 10 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 17 May 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 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?

To determine the MTD of PX-478 administered orally on days one to five of a 21 day cycle (time frame: 21 days). 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 NCT00522652, which also lists 1 linked publication.

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 17 May 2018.

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