Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib for Pancreatic Cancer

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, NY
Pancreatic Cancer+3 More Conditionsavutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel - Drug
Eligibility
18+
All Sexes

Study Summary

This trial will test a new combo of drugs to treat people with pancreatic cancer who haven't had treatment before.

Eligible Conditions
  • KRAS Activating Mutation
  • Metastatic Cancer
  • Pancreatic Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Up to 5 years

10 Weeks
Plasma Pharmacokinetics (PK) of avutometinib (VS-6766) and Defactinib and relevant metabolites, AUC
10 weeks
Plasma Pharmacokinetics (PK) of avutometinib (VS-6766) and Defactinib and relevant metabolites, Half-life
Plasma Pharmacokinetics (PK) of avutometinib (VS-6766) and Defactinib and relevant metabolites, Tmax
24 months
Disease Control Rate (DCR)
Duration of Response (DOR)
Frequency and severity adverse events (AEs) and Serious Adverse Events (SAEs)
Number of abnormal laboratory values
Progression Free Survival (PFS)
28 days
Part A: To determine RP2D for avutometinib (VS-6766) and defactinib in combination gemcitabine and nab-paclitaxel
6 months
To determine the efficacy of the RP2D identified in Part A
Up to 5 years
Overall Survival (OS)

Trial Safety

Phase-Based Safety

1 of 3

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1
Bosentan
2
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib
1 of 2
Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib RP2D
1 of 2

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib · No Placebo Group · Phase 1 & 2

Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib
Drug
Experimental Group · 1 Intervention: avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel · Intervention Types: Drug
Gemcitabine + nab-paclitaxel + avutometinib (VS-6766) + defactinib RP2D
Drug
Experimental Group · 1 Intervention: avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

Verastem, Inc.Lead Sponsor
35 Previous Clinical Trials
2,122 Total Patients Enrolled
MD VerastemStudy DirectorVerastem, Inc.
4 Previous Clinical Trials
422 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

To what extent is enrollment being opened for this research project?

"Indeed, details available on clinicaltrials.gov show that this experiment is actively trying to recruit individuals. It was first posted on the 15th of January in 2023 and most recently updated on the 3rd of January also in 2023, with 40 patients being sought from a single medical centre." - Anonymous Online Contributor

Unverified Answer

Is this clinical experiment recruiting participants currently?

"Affirmative. According to clinicaltrials.gov, this trial is actively recruiting patients; it was initially posted on January 15th 2023 and most recently updated on March 1st 2023. 40 participants are needed from a single site for participation in the study." - Anonymous Online Contributor

Unverified Answer

What are the primary aims of this research endeavor?

"The study sponsor, Verastem Inc., has declared that the primary outcome to be measured over a period of 28 days is determining efficacy at the RP2D identified in Part A. Secondary outcomes include Duration of Response (TFO), Overall Survival (OS) and Plasma Pharmacokinetics (PK). Additionally, they will measure Tmax or Time to Maximum concentration." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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