NCT02993913

A Safety, Tolerability and Pharmacokinetic Study of Single and Repeat Oral Escalating Doses of Simmiparib in Patients With Advanced Malignant Tumors

Status unknown Phase 1 Last updated 3 January 2017

What this trial tests

Phase 1 trial testing Simmiparib in Malignant Advanced Solid Tumor in 50 participants. Status unknown.

Timeline

1 December 2016

Primary endpoint
1 December 2018

Quick facts

Lead sponsor	Shanghai Acebright Pharmaceuticals Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Enrollment	50
Start date	1 December 2016
Primary completion	1 December 2018
Sites	1 location across China

Drugs / interventions tested

• Simmiparib — full drug profile →

Conditions studied

• Malignant Advanced Solid Tumor — all drugs for Malignant Advanced Solid Tumor →

Sponsor

Shanghai Acebright Pharmaceuticals Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Malignant Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Maximum Tolerated Dose (MTD)
  Time frame: Per doselevel of 3 to 6 patients (When 3-6 patients have completed DLT periods of 4 weeks)
  The Dose level at which more than 1/6 patients develop a Dose Limiting Toxicity (DLT)
• Pharmacokinetic Cmax (maximum concentration)
  Time frame: At day 1 single dose period, day 8 and 28 multiple dose period day
  PK blood collection Before 0:00h and after 0.25h、0.50h、1:00h、1.50h、2:00h、3:00h、4:00h、6:00h、8:00h、10:00h、24:00h、48:00h、72:00h at single dose period. PK blood collection before 0:00h and after 0.25h、0.50、1:00h、1.50h、2:00h、3:00h、4:00h、6:00h、8:00h、10:00h and 12:00h at multiple dose period
• Pharmacokinetic Tmax (Time of maximum concentration)
  Time frame: At day 1 single dose period, day 8 and 28 multiple dose period day
• Pharmacokinetics AUC (Area Under the Curve)
  Time frame: At day 1 single dose period, day 8 and 28 multiple dose period day

Sponsor's own description

Phase I dose escalating trial. Primary objectives of this study are to assess the safety and tolerability of Simmiparib following single and multiple oral doses in patients with advanced solid malignancies, to determine the maximum tolerance dose (MTD) and dose limiting toxicity (DLT), and pharmacokinetic profile.

The Secondary objective is to observe the preliminary antitumor effect of Simmiparib.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting DNA repair for cancer treatment: Lessons from PARP inhibitor trials.
   Nambiar DK, Mishra D, Singh RP. · · 2023 · cited 40× · PMID 37415740 · DOI 10.32604/or.2023.028310
2. Antitumor activity and structure-activity relationship of poly (ADP-ribose) polymerase (PARP)-based dual inhibitors.
   Yang C, Shang Y, Li X, Li J, et al · · 2026 · PMID 41395847 · DOI 10.1080/14756366.2025.2598478