Source: https://www.pfizer.com/science/find-a-trial/nct04171141
Timestamp: 2020-07-08 04:03:44
Document Index: 359895213

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NCT04171141 | Gastrointestinal Tumors, Colorectal Adenocarcinomas, Gastric Adenocarcinomas, Esophageal Adenocarcinomas Clinical Trial | Pfizer
Our Science/Clinical Trials/Find a Trial/ NCT04171141
A phase 1, open‑label, dose escalation and expansion study of PF‑07062119 in patients with selected advanced or metastatic gastrointestinal tumors
Gastrointestinal Tumors, Colorectal Adenocarcinomas, Gastric Adenocarcinomas, Esophageal Adenocarcinomas
- For Part 1 and Part 2, diagnosis of advanced/metastatic colorectal, gastric or esophageal adenocarcinoma that is resistant to standard therapy or for which no local regulatory approved standard therapy is available that would confer significant benefit.
- For Part 2, diagnosis of colorectal adenocarcinoma that is resistant to standard therapy or for which no standard therapy is available
- Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1)
- Major surgery or radiation within 3 weeks prior to study entry
- Last anti-cancer treatment within 4 weeks prior to study entry
- Active or history of clinically significant autoimmune disease that required systemic
- Active or history of clinically significant gastrointestinal disease
Gastrointestinal Tumors, Colorectal Adenocarcinomas, Gastric Adenocarcinomas, Esophageal AdenocarcinomasStudy to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07062119 IN PATIENTS WITH ADVANCED GASTROINTESTINAL TUMORS
A phase 1, open?label, dose escalation and expansion study of PF?07062119 in patients with selected advanced or metastatic gastrointestinal tumors
This is a Phase 1, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic study of PF-07062119 administered as a single agent in sequential dose levels and then in combination with anti-programmed cell death -1 protein (anti-PD-1) and in combination with an anti-vascular endothelial growth factor (anti-VEGF). In Part 1A, successive cohorts of patients will receive escalating doses of PF-007062119 and then in dose finding (Part 1B) with PF-07062119 in combination with anti-PD-1 and in combination with anti-VEGF. This study contains 2 parts, dose escalation with single agent (Part 1A) and then dose finding with PF-007062119 in combination with ant-PD-1 and in combination with anti-VEGF (Part 1B) followed by dose expansion arms as a single agent and PF-07062119 in combination with anti-PD 1 and in combination with anti-VEGF (Part 2).
Drug: PF-07062119
PF-07062119
Drug: Anti-PD1
Anti-PD1 PF-06801591
Anti-VEGF IV (bevacizumab)
Intervention: Drug: PF-07062119
Experimental: Dose Finding Anti-PD-1 Combination
Part 1B PF-07062119 plus anti-PD-1
Experimental: Dose Finding anti-VEGF Combination
Part 1B PF-07062119 plus anti-VEGF
PF-07062119 as a Single Agent in CRC
PF-07062119 in Combination with anti-PD-1 in CRC
PF-07062119 in Combination with anti-VEGF in CRC
PF-07062119 in Combination with either anti-PD-1 or anti-VEGF in various Tumor Types
June 14, 2023 (Final data collection date for primary outcome measure)
For Part 1 and Part 2, diagnosis of advanced/metastatic colorectal, gastric or esophageal adenocarcinoma that is resistant to standard therapy or for which no local regulatory approved standard therapy is available that would confer significant benefit.
For Part 2, diagnosis of colorectal adenocarcinoma that is resistant to standard therapy or for which no standard therapy is available
Last anti-cancer treatment within 4 weeks prior to study entry
Active or history of clinically significant autoimmune disease that required systemic immunosuppressive medication
Active or history of clinically significant gastrointestinal disease
Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry
C3861001
GUCY2C ( Other Identifier: Alias Study Number )