NCT05251038

Study of Sotorasib Combined With Chemotherapy for Second Line Treatment of Pancreas Cancer

Withdrawn Phase 1, PHASE2 Last updated 11 May 2023

What this trial tests

Phase 1, PHASE2 trial testing Sotorasib in Pancreatic Cancer. Withdrawn.

Timeline

13 September 2022

Primary endpoint
31 January 2023

31 January 2023

Quick facts

Lead sponsor	Devalingam Mahalingam
Phase	Phase 1, PHASE2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	13 September 2022
Primary completion	31 January 2023
Estimated completion	31 January 2023
Sites	1 location across United States

Drugs / interventions tested

• Sotorasib (SOTORASIB) — full drug profile →
• Liposomal Irinotecan (nal-IRI) — full drug profile →
• 5 Fluorouracil (5FU)
• Leucovorin (LV) (leucovorin-lv) — full drug profile →
• Gemcitabine (GEM) — full drug profile →
• Nab paclitaxel

Conditions studied

• Pancreatic Cancer — all drugs for Pancreatic Cancer →
• Unresectable Pancreatic Cancer — all drugs for Unresectable Pancreatic Cancer →
• Metastatic Pancreatic Cancer — all drugs for Metastatic Pancreatic Cancer →
• KRAS P.G12C — all drugs for KRAS P.G12C →

Sponsor

Devalingam Mahalingam — full company profile →

Who can join

18 and older, any sex, with Pancreatic Cancer or Unresectable Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, non-randomized, open-label, phase Ib/II study to evaluate the safety, tolerability and efficacy of sotorasib in combination with chemotherapy for patients with advanced KRAS p.G12C mutant pancreatic cancer with progression of disease after first line treatment. There will be a safety lead in to determine the safety and tolerability of the sotorasib in combination with standard chemotherapy. A Simon two-stage design will be employed to evaluate the efficacy of sotorasib in combination with standard of care second line chemotherapy.

Publications & conference data

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

1. The current state of the art and future trends in RAS-targeted cancer therapies.
   Punekar SR, Velcheti V, Neel BG, Wong KK. · · 2022 · cited 382× · PMID 36028717 · DOI 10.1038/s41571-022-00671-9
2. Targeting small GTPases: emerging grasps on previously untamable targets, pioneered by KRAS.
   Yin G, Huang J, Petela J, Jiang H, et al · · 2023 · cited 50× · PMID 37221195 · DOI 10.1038/s41392-023-01441-4
3. Are targeted therapies or immunotherapies effective in metastatic pancreatic adenocarcinoma?
   Rémond MS, Pellat A, Brezault C, Dhooge M, et al · · 2022 · cited 22× · PMID 36399952 · DOI 10.1016/j.esmoop.2022.100638
4. Direct GDP-KRAS^G12C inhibitors and mechanisms of resistance: the tip of the iceberg.
   Rosen JC, Sacher A, Tsao MS. · · 2023 · cited 15× · PMID 36950276 · DOI 10.1177/17588359231160141
5. New Treatment Options in Metastatic Pancreatic Cancer.
   Fudalej M, Kwaśniewska D, Nurzyński P, Badowska-Kozakiewicz A, et al · · 2023 · cited 13× · PMID 37190255 · DOI 10.3390/cancers15082327
6. Pathogenic genomic alterations in Chinese pancreatic cancer patients and their therapeutical implications.
   Zhao Z, Li X, Wang F, Xu Y, et al · · 2023 · cited 13× · PMID 36999792 · DOI 10.1002/cam4.5871
7. Genetic Signature of Human Pancreatic Cancer and Personalized Targeting.
   Reshkin SJ, Cardone RA, Koltai T. · · 2024 · cited 9× · PMID 38607041 · DOI 10.3390/cells13070602
8. Emerging kinase inhibitors for the treatment of pancreatic ductal adenocarcinoma.
   Rudloff U. · · 2022 · cited 9× · PMID 36250721 · DOI 10.1080/14728214.2022.2134346