Study of PX-866 and Docetaxel in Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oncothyreon Inc.
ClinicalTrials.gov Identifier:
NCT01204099
First received: September 15, 2010
Last updated: November 1, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Non Small Cell Lung Cancer (NSCLC)
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Drug: Docetaxel
Drug: PX-866 and Docetaxel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1/2 Study of PX-866 and Docetaxel in Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Oncothyreon Inc.:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Incidence and severity of adverse events [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 206
Study Start Date: September 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Docetaxel
Other Name: taxotere
Experimental: PX-866 and Docetaxel (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.
Drug: PX-866 and Docetaxel
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.
Drug: Docetaxel
Other Name: taxotere
Experimental: PX-866 and Docetaxel (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.
Drug: PX-866 and Docetaxel

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204099

  Show 33 Study Locations
Sponsors and Collaborators
Oncothyreon Inc.
  More Information

No publications provided

Responsible Party: Oncothyreon Inc.
ClinicalTrials.gov Identifier: NCT01204099     History of Changes
Other Study ID Numbers: PX-866-002
Study First Received: September 15, 2010
Last Updated: November 1, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Oncothyreon Inc.:
PX-866
Non small cell lung cancer
solid tumors
Squamous cell cancer of the head and neck
docetaxel
NSCLC
taxotere
SCCHN
PI-3K
PI3 kinase
PI3K

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Lung Neoplasms
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Squamous Cell
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014