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CompletedNCT00522652Updated May 17, 2018

Phase I Trial of PX-478

A Phase 1 interventional study of PX-478 in Advanced Solid Tumors and Lymphoma, sponsored by Cascadian Therapeutics Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-17.

Sponsored by Cascadian Therapeutics Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Solid Tumors
  • Lymphoma

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Keywords

  • cancer
  • advanced cancer
  • lymphoma
03

In context

Lymphoma

5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 45 is above the median of 40 across 4,509 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Cascadian Therapeutics Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Investigational Drug

    Dose Escalation

    Drug: PX-478

Interventions

  • DrugPX-478

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

06

What researchers measure

Primary outcomes

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

    Time frame: 21 days

Secondary outcomes

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

    Time frame: 42 days

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

    Time frame: 42 days

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

    Time frame: 21 days

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

    Time frame: 21 days

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

    Time frame: 42 days

07

Study locations

2 sites
  • TGen Clinical Research Services at Scottsdale Healthcare
    Scottsdale, Arizona 85258, United States
  • The University of Texas M.D. Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00522652
Lead sponsor
Cascadian Therapeutics Inc.
First posted
Aug 30, 2007
Start date
Aug 2007
Primary completion
May 2010
Completion
May 2010
Last update
May 17, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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