Ann: June 2019 Appendix 4C - Quarterly, page-134

	Study Start Date:	January 2012
1	EstimatedPrimary Completion Date:	December 2019
2	EstimatedStudy Completion Date:	December 2022

@relaxin

I am not sure why the total number of participants is 34 rather than 26 as announced.... based upon clinicaltrials.gov 34 patients are confirmed to be enrolled and study recruitment has closed.

Summary of trial:

OUTLINE: This is a phase I, dose-escalation study of triciribine phosphate followed by an expansion cohort and a phase II study.

COURSES A 1-12 (PHASE I & II): Patients receive triciribine phosphate intravenously (IV) over 60 minutes on days 1, 8, and 15, 29, 36, 43, 57, 64, and 71 and paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 79. Treatment repeats every week for 12 courses in the absence of disease progression or unacceptable toxicity.

COURSES B 1-4 (PHASE II): Patients receive doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.

SURGERY (PHASE II): Eligible patients undergo modified radical mastectomy, radical mastectomy, segmental mastectomy or lumpectomy with an axillary lymph node dissection or biopsy. After completion of study treatment, patients with metastatic disease are followed up every 3 months for 1 year and patients with locally advanced disease are followed up every 6 months for 2 years and then yearly for 3 years.

My read of this is as follows:

5 patients from the Phase 1B study completed 12 weeks of PTX + paclitaxel and were eligible to proceed to course B (dose dense AC protocol part of phase II). 2 out of these 5 patients achieved pCR (determined after dose dense AC).

The next 6 patients were enrolled as Phase II participants (PTX + paclitaxel followed by dose dense AC). At least one of these patients (hopefully >3) must have pCR for the study to continue.

The next 15 patients are enrolled in phase II taking the phase II cohort to 26 patients as planned.

Based upon the details in previous announcements, I can only assume the Phase II trial was extended by an additional 8 patients (this has not been announced), which could only occur if a significant number of patients were pCR after chemotherapy.


My prediction:

PTX-200 has incredible results for ER+ women and reasonably efficacy (superior to current treatment) for locally advanced Triple negative disease.
PTX-200 does not help women with metastatic Triple negative disease (no treatment can cure this group sadly).

That would be incredible - even if I am only 50% correct.