A Phase 1/2a, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Activity of PEN-866 in Patients With Advanced Solid Malignancies

NCT03221400 Phase 1/Phase 2 UNKNOWN

Protocol PEN-866-001 is an open-label, multi-center, first-in-human Phase 1/2a study evaluating PEN-866 in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies.

Details

Lead sponsor	Tarveda Therapeutics
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	340
Start date	2017-08-29
Completion	2023-06

Conditions

• Carcinoma
• Endometrial Adenocarcinoma
• Neoplasms
• Squamous Cell Carcinoma of the Anus
• Adenocarcinoma of the Pancreas
• Advanced Cancer
• Solid Tumor
• Solid Carcinoma
• Squamous Cell Carcinoma of the Cervix
• Squamous Cell Carcinoma

Interventions

• PEN-866 Sodium
• fluorouracil
• Folinic acid
• Niraparib

Primary outcomes

• Phase 1a and 1b : Incidence of Dose-Limiting Toxicities (DLTs) — Patients will be followed for 28 days to determine the incidence of DLTs.
  The Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) will be determined by assessing the incidence of DLTs and treatment related adverse events of PEN-866 as a single agent (Phase 1a) or in combination therapy (Phase 1b).
• All Phases: Incidence of treatment related adverse events (Safety and tolerability) — From date of first treatment/trial entry up to 28 days following the last treatment.
  Safety and tolerability will be determined by assessing the incidence of treatment related adverse events.
• Phase 2a: Efficacy of PEN-866 in patients with SCLC using best overall response rate — From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
  Efficacy of PEN-866 in patients with SCLC will be assessed using best overall tumor response rate defined as complete response (CR) or partial response (PR) according to RECIST 1.1.
• Phase 2a: Efficacy of PEN-866 in patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma using best overall response rate — From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
  Efficacy of PEN-866 in patients with gastric or GEJ adenocarcinoma will be assessed using best overall tumor response rate defined as CR or PR according to RECIST 1.1.
• Phase 2a: Efficacy of PEN-866 in patients with pancreatic adenocarcinoma using Disease Control Rate (DCR) — From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
  Efficacy of PEN-866 in patients with pancreatic adenocarcinoma will be assessed using DCR defined as a best response of CR, PR, or stable disease (SD) according to RECIST 1.1.
• Phase 2a: Efficacy of PEN-866 in patients with endometrial adenocarcinoma using best overall response rate — From the date of first treatment through the date of first documented progression, assessed up to (estimated) 18 months
  Efficacy of PEN-866 in patients with endometrial adenocarcinoma will be assessed using best over all tumor response rate defined as CR or PR according to RECIST 1.1.

Countries

United States