A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer

NCT01331083 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: I205
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to find out whether the new drug PX-866 will slow the growth of your prostate cancer. The investigators will also watch you carefully for any side effects that PX-866 might cause.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Lack of Disease Progression at 12 Weeks

  Proportion of patients without evidence of progression (objective progression, defined as an increase in sum of diameters of target lesions of at least 20% above the lowest (or baseline) value (minimum of 5 mm increase) OR the appearance of unequivocal increase in non-measurable/non-target disease OR the appearance of new lesions, or PSA progression, defined as a rise in PSA of 25% (minimum 5 ng/ml) above baseline value or nadir, whichever is lowest, and confirmed by a second increasing value at least 3 weeks later) at 12 weeks after start of therapy

  12 weeks

Secondary Outcomes (3)

• PSA Response Rate

  12 weeks

• Objective Response Rate

  12 weeks

• Change in Circulating Tumour Cell Number During Treatment

  12 weeks

Study Arms (1)

PX-866

EXPERIMENTAL

Drug: PX-866

Interventions

PX-866 DRUG

PX-866: 8mg orally taken daily

PX-866

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histological or cytological diagnosis of adenocarcinoma of the prostate.
• All patients must have formalin fixed paraffin embedded tissue (from their primary or metastatic tumour) available for translational studies.
• Presence of clinically and/or radiologically documented disease (measureable or non-measurable). All radiology studies must be performed within 28 days prior to registration (within 35 days if negative).
• Androgen ablation must include either medical or surgical castration. If the patient is receiving medical androgen ablation, a castrate level of testosterone (\< 1.7 nmol/L) must be present.
• Patients must have metastatic or locally recurrent disease, for which no curative therapy exists and for which systemic therapy is indicated.
• No prior chemotherapy regimens for recurrent disease
• For Part A, patients must have progression defined as:
• PSA Progression: A rising PSA, while receiving androgen ablative therapy, with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of ≥ 5 ng/ml and must be performed no longer than 7 days prior to trial registration.
• OR Radiological Progression: defined as the development of new metastatic lesions with a stable or rising PSA.
• Patients entered to Part B of the study (after 2nd stage of accrual completed) must have a rise in their PSA while on abiraterone/prednisone continuing at time of registration (≥ 25% higher from baseline or nadir, whichever is lowest).
• The PSA must be ≥5 ng/ml at the time of study entry.
• ECOG performance of 0, 1 or 2.
• Age ≥ 18 years of age.
• Previous therapy:
• Surgery:

You may not qualify if:

• Patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer or solid tumours curatively treated with no evidence of disease for \>=3 years.
• Known HIV-positive patients.
• Uncontrolled diabetes mellitus.
• Patients with upper gastrointestinal or other conditions that would preclude compliance or absorption of oral medication are not eligible.
• Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
• Patients are not eligible if they have a known hypersensitivity to the study drug(s) or their components.
• Patients with history of central nervous system metastases or untreated spinal cord compression.
• Patients who have had prior treatment with a PI3 kinase inhibitor.
• Men who are not sterile unless they use an adequate method of birth control.
• Patients enrolled to Part B must be suitable for continued therapy with abiraterone/prednisone.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• Oncothyreon Canada Inc.: collaborator

Study Sites (10)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (1)

• Hotte SJ, Chi KN, Joshua AM, Tu D, Macfarlane RJ, Gregg RW, Ruether JD, Basappa NS, Finch D, Salim M, Winquist EW, Torri V, North S, Kollmannsberger C, Ellard SL, Eigl BJ, Tinker A, Allan AL, Beja K, Annala M, Powers J, Wyatt AW, Seymour L; Canadian Cancer Trials Group (formerly NCIC Clinical Trials Group). A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration-resistant Prostate Cancer: Canadian Cancer Trials Group Study IND205. Clin Genitourin Cancer. 2019 Jun;17(3):201-208.e1. doi: 10.1016/j.clgc.2019.03.005. Epub 2019 Mar 15.

  PMID: 31056399 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

PX-866

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Lesley Seymour
• Organization: Canadian Cancer Trials Group

lseymour@ctg.queensu.ca

6135336430

Study Officials

• Kim Chi

  BCCA Vancouver Cancer Centr

  STUDY CHAIR

• Sebastien Hotte

  Juravinski Cancer Centre at Hamilton Health Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 7, 2011
• Study Start: September 9, 2011
• Primary Completion: January 13, 2015
• Study Completion: November 27, 2015
• Last Updated: August 22, 2023
• Results First Posted: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)