TSR-042 for Rectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hartford Healthcare (Data Collection), Hartford, CTRectal Cancer+4 MoreTSR-042 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it, combined with other standard treatments, is effective against a type of solid tumor. The trial will also monitor for side effects.

Eligible Conditions
  • Rectal Cancer
  • Solid Tumors
  • Solid Tumors, Adult
  • Stage III Cancer
  • Stage II Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 12 months

12 months
Pathologic complete response (pCR) or complete clinical response (cCR) at 12 months

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Cohort 1
1 of 1

Experimental Treatment

200 Total Participants · 1 Treatment Group

Primary Treatment: TSR-042 · No Placebo Group · Phase 2

Cohort 1Experimental Group · 4 Interventions: TSR-042, TSR-042 or Dostarlimab, capecitabine or 5-FU, Intensity Modulated Radiation Therapy (IMRT) · Intervention Types: Drug, Drug, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity Modulated Radiation Therapy (IMRT)
2010
Completed Phase 1
~40

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,847 Previous Clinical Trials
589,928 Total Patients Enrolled
Tesaro, Inc.Industry Sponsor
56 Previous Clinical Trials
10,479 Total Patients Enrolled
Andrea Cercek, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
1,186 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 12 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a type of cancer that is typically treated with medication before surgery.

Frequently Asked Questions

In how many different places can people participate in this trial?

"There are 11 enrolment sites for this clinical trial, including Lehigh Valley Health Network (Data Collection Only) in Allentown, Pennsylvania, Memorial Sloan Kettering Monmouth - Limited Protocol Activities in Middletown, New Jersey and Memoral Sloan Kettering Westchester - Limited Protocol Activities in Harrison, New York." - Anonymous Online Contributor

Unverified Answer

Are there any limitations to who can sign up for this particular clinical trial?

"Yes, this research is currently looking for volunteers to participate. The trial was first advertised on December 11th 2019 and has since been updated on October 12th 2020." - Anonymous Online Contributor

Unverified Answer

What else is known about TSR-042 from past research?

"TSR-042 was first trialled at Withington Hospital in 2005. So far, 555 completed trials have been conducted. Currently, there are 393 ongoing studies recruiting participants, many of which based in Allentown, Pennsylvania." - Anonymous Online Contributor

Unverified Answer

What are the benefits of TSR-042?

"TSR-042 is an effective medication for patients suffering from metastatic colorectal carcinoma, pancreatic endocrine carcinoma, and refractory ovarian cancer." - Anonymous Online Contributor

Unverified Answer

Has the FDA cleared TSR-042 for general use?

"Because TSR-042 is only in Phase 2 trials, there is not yet enough data to support its efficacy. However, there is some evidence that suggests it is safe, so it received a score of 2." - Anonymous Online Contributor

Unverified Answer

How many people are participating in this clinical trial?

"In order to gather the data required, 51 individuals that meet the pre-determined inclusion criteria are needed to participate. These chosen patients can come from different hospitals, such as Lehigh Valley Health Network (Data Collection Only) in Allentown, Pennsylvania and Memorial Sloan Kettering Monmouth - Limited Protocol Activities in Middletown, New Jersey." - 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.