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A Trial of PX-12 in Patients With a Histologically or Cytologically Confirmed Diagnosis of Advanced or Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00736372
Recruitment Status : Completed
First Posted : August 15, 2008
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Seagen Inc. ( Cascadian Therapeutics Inc. )

Tracking Information
First Submitted Date  ICMJE August 13, 2008
First Posted Date  ICMJE August 15, 2008
Last Update Posted Date May 17, 2018
Study Start Date  ICMJE June 2008
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
To determine the MTD of PX-12 delivered as a 72-hour infusion over days 1, 2, and 3 of a 21-day cycle [ Time Frame: 21 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2008)
  • When delivered as a 72 hour intravenous infusion on days 1, 2, and 3 of a 21-day cycle: Evaluate the safety profile of PX-12 [ Time Frame: 42 days ]
  • When delivered as a 72 hour intravenous infusion on days 1, 2, and 3 of a 21-day cycle: Assess the pharmacodynamics of PX-12 using surrogate tissues obtained pre- and post-drug treatment [ Time Frame: 42 days ]
  • When delivered as a 72 hour intravenous infusion on days 1, 2, and 3 of a 21-day cycle: Assess pharmacokinetic profiles of PX-12 in plasma samples [ Time Frame: 42 days ]
  • When delivered as a 72 hour intravenous infusion on days 1, 2, and 3 of a 21-day cycle: Identify any antitumor activity of PX-12 in this patient population [ Time Frame: 42 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of PX-12 in Patients With a Histologically or Cytologically Confirmed Diagnosis of Advanced or Metastatic Cancer
Official Title  ICMJE A Phase Ib Trial of PX-12 Administered as a 72-Hour Infusion Every 21 Days in Patients With a Histologically or Cytologically Confirmed Diagnosis of Advanced or Metastatic Cancer That is Refractory to Standard Treatment
Brief Summary PX-12 (1-methylpropyl 2-imidazolyl disulfide) is a novel small molecule inhibitor of thioredoxin-1, a small protein over-expressed in many human cancers that is associated with aggressive tumor proliferation, angiogenesis, and drug resistance. This study is being conducted to determine the maximally tolerated dose of PX-12 delivered as a 72-hour infusion over days 1, 2, and 3 of a 21-day cycle in patients with advanced or metastatic cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Cancer
  • Advanced Cancer
Intervention  ICMJE Drug: PX-12
Intravenous infusion, dose escalation, infused over a 72 hour period on days 1, 2 and 3 of a 21-day cycle until progression or development of unacceptable toxicity
Study Arms  ICMJE Experimental: Investigational Drug
Dose Escalation
Intervention: Drug: PX-12
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2009)
14
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2008)
16
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients with histologically or cytologically confirmed diagnosis of advanced or metastatic cancer or lymphoma whose tumors are refractory to standard therapy or for whom no standard therapy is available that increases survival by at least three months.
  2. Men and women at least 18 years of age.
  3. A predicted life expectancy of at least 12 weeks.
  4. ECOG performance status of 0-2 .
  5. Patients must have discontinued previous anticancer therapy and/or other investigational agents at least three weeks prior to treatment with PX-12 (six weeks for mitomycin C and nitrosureas) and recovered (grade 1 or less) from the toxic effects of that treatment. In the case of oral agents with a short half life, on a case by case basis, a minimum of a two week interval may be permitted.
  6. Patients must have discontinued any radiation therapy at least four weeks prior to treatment with PX-12 and have recovered from all radiation-related toxicities. Palliative radiation of 10 fractions or less is permitted and a four week interval is not necessary (also allowed during therapy).
  7. The patient has adequate hematologic function as defined by the following:

    platelets >100,000/μL; hemoglobin >9 g/dL (may be transfused to this level); ANC > 1,500 cells/μL.

  8. The patient has adequate hepatic function as defined by the following: bilirubin <2.0 mg/dL;aspartate aminotransaminase (AST/SGOT) & alanine aminotransferase (ALT/SGPT) <2.5 times (or up to five ULN for patients with liver metastases) institutional upper limit of normal (ULN). International Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) within 1.5 times ULN unless subject is on coumadin.
  9. The patient has adequate renal function as defined by serum creatinine level

    ≤ 1.5 x ULN.

  10. Patient has signed informed consent.
  11. Patient is compliant with the study and in geographic proximity to allow adequate follow-up.
  12. 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. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician

Exclusion Criteria:

  1. Patients with symptomatic pulmonary disease, e.g., active chronic obstructive/restrictive pulmonary disease, asthma, evidence of interstitial pneumonitis, pulmonary fibrosis, etc.
  2. Patients with history of dyspnea, dyspnea on exertion, or paroxysmal nocturnal dyspnea.
  3. Patients that meet the Medicare criteria for receiving home oxygen or are on oxygen.
  4. Patients with a history of prior lung radiation.
  5. Patients with any active infection requiring i.v. antibiotics at study entry.
  6. Any serious concomitant systemic disorders that in the opinion of the investigator would place the patient at excessive or unacceptable risk of toxicity.
  7. Significant central nervous system or psychiatric disorder(s) that preclude the ability of the patient to provide informed consent.
  8. 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.
  9. Major surgery within four weeks of treatment with PX-12.
  10. Patients with a history of seizures.
  11. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  12. Patients who are breastfeeding or pregnant (confirmed by serum β-HCG within 10 days prior to the start of study treatment if applicable).
  13. Any condition that could jeopardize the safety of the patient and compliance with the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00736372
Other Study ID Numbers  ICMJE PX-12-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seagen Inc. ( Cascadian Therapeutics Inc. )
Study Sponsor  ICMJE Cascadian Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seagen Inc.
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP