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Study of PX-866 and Docetaxel in Solid Tumors

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ClinicalTrials.gov Identifier: NCT01204099
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Seagen Inc. ( Cascadian Therapeutics Inc. )

Tracking Information
First Submitted Date  ICMJE September 15, 2010
First Posted Date  ICMJE September 17, 2010
Last Update Posted Date May 16, 2018
Study Start Date  ICMJE September 2010
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2011)
Progression Free Survival [ Time Frame: 42 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
Incidence and severity of adverse events in phase 1 [ Time Frame: 42 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2011)
  • Objective response rate (ORR) [ Time Frame: 42 days ]
  • Incidence and severity of adverse events [ Time Frame: 42 days ]
  • Overall survival [ Time Frame: 42 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2010)
Objective response rate (ORR) and early progression rate (% of patients with progressive disease at 6 weeks) [ Time Frame: 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of PX-866 and Docetaxel in Solid Tumors
Official Title  ICMJE Phase 1/2 Study of PX-866 and Docetaxel in Patients With Solid Tumors
Brief Summary

Phase 1: To determine the maximally tolerated dose (MTD) or recommended dose (RD) and any potential efficacy of PX-866 in combination with docetaxel in patients with solid tumors.

Phase 2: To determine the antitumor activity and safety of PX-866 in combination with docetaxel versus docetaxel alone in patients with NSCLC or SCCHN.

Detailed Description

This is a Phase 1/2 open-label study. In the Phase 1 part of the study, PX-866 was given in combination with docetaxel to patients with incurable locally advanced, recurrent or metastatic cancer.

Phase 2 of the study is an open-label, randomized evaluation of the antitumor activity and safety of PX-866, administered at the MTD/RD identified in Phase 1 (8mg daily), in combination with docetaxel versus docetaxel alone in patients with locally advanced, recurrent, or metastatic NSCLC (Group 1) or patients with locally advanced, recurrent, or metastatic SCCHN (Group 2).

Group 1 (patients with locally advanced, recurrent, or metastatic NSCLC) is now closed to enrollment.

All treatments will be administered on a 21-day cycle. Docetaxel 75 mg/m2 will be administered IV on Day 1 of each 21-day cycle. PX-866 will be administered orally or via PEG tube (if applicable) once per day on Days 1 to 21 of all treatment cycles in patients randomized to the treatment arm containing PX-866.

Patients will be evaluated for progression approximately every 6 weeks. Patients with stable disease (SD) or better, per investigator assessment, will receive repeat cycles of treatment on a 21-day schedule until disease progression, unacceptable toxicity or withdrawal of consent.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non Small Cell Lung Cancer (NSCLC)
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Intervention  ICMJE
  • Drug: Docetaxel
    Other Name: taxotere
  • Drug: PX-866
Study Arms  ICMJE
  • Active Comparator: Docetaxel (NSCLC)
    IV docetaxel administered once every three weeks as per standard of care. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent.
    Intervention: Drug: Docetaxel
  • Experimental: PX-866 (NSCLC)
    Oral PX-866 administered daily at the RD in combination with IV docetaxel administered once every three weeks on a 21 day cycle. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent.
    Interventions:
    • Drug: Docetaxel
    • Drug: PX-866
  • Active Comparator: Docetaxel (SCCHN)
    IV docetaxel administered once every three weeks as per standard of care. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent.
    Intervention: Drug: Docetaxel
  • Experimental: PX-866 (SCCHN)
    Oral PX-866, administered daily at the RD in combination with IV docetaxel administered once every three weeks on a 21 day cycle. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent.
    Interventions:
    • Drug: Docetaxel
    • Drug: PX-866
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: April 30, 2015)
223
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2010)
117
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years at time of consent
  • Agrees to use a medically accepted form of contraception from the time of consent to completion of all follow up study visits
  • If female of child bearing potential, negative pregnancy test (not required for post menopausal females)
  • Signed an informed consent document that has been approved by an institutional review board or independent ethics committee (IRB/IEC)
  • Has either locally advanced, recurrent, or metastatic NSCLC for which they have received at least 1 and no more than 2 prior systemic treatment regimens that may include up to 1 platinum based chemotherapy regimen and/or an epidermal growth factor receptor (EGFR) inhibitor OR locally advanced, recurrent or metastatic SCCHN for which they have received at least one and no more than two prior systemic treatment regimens.
  • Measurable disease per Response Evaluation Criteria In Solid Tumors
  • Eastern Cooperative Oncology Group (ECOG) 0 or 1
  • In the opinion of the clinical investigator, life expectancy >3 months
  • Adequate hematologic function as defined by:

    • Hemoglobin ≥ 9 g/dL
    • Absolute neutrophil count (ANC) ≥1500 cells/µL
    • Platelets ≥100,000/µL
  • Adequate hepatic function as defined by the following:

    • Bilirubin ≤ ULN
    • Aspartate aminotransaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤1.5 x upper limit of normal (ULN)
  • Creatinine level ≤1.5 x ULN

Exclusion Criteria:

  • Has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
  • Is breastfeeding
  • Treatment with any systemic chemotherapy, epidermal growth factor receptor (EGFR) inhibitor, radiation or experimental agent within 4 weeks of study drug dosing. Washout period following palliative radiation should be discussed with the study medical monitor
  • Previous treatment with docetaxel except for patients in Phase 2 who received a docetaxel containing regimen as part of adjuvant or neoadjuvant therapy which was completed at least 6 months prior to study drug dosing
  • Previous treatment with a phosphatidylinositol 3 kinase (PI 3K) inhibitor
  • Known human immunodeficiency virus (HIV)
  • Known or suspected clinically active brain metastases. Previously treated and stable brain metastases are allowable. Stable brain metastases are defined as no change on CT scan or MRI for minimum of two months AND no change in steroid dose for a minimum of four weeks, unless change due to intercurrent infection or other acute event
  • Grade >2 peripheral neuropathy, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.02
  • Any other significant medical or psychiatric condition that in the opinion of the investigator renders the patient inadequate for participation
  • History of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate
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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01204099
Other Study ID Numbers  ICMJE PX-866-002
Has Data Monitoring Committee Yes
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 April 2015

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