Small Molecule Drug

BLU-701 for Protein Kinase Inhibitors

Dana-Farber Cancer Institute, Boston, MA
Targeting 30 different conditionsBLU-701 +3 morePhase 1Waitlist AvailableResearch Sponsored by Blueprint Medicines Corporation

Study Summary

This trial is testing a new drug, BLU-701, to see if it is safe and effective against EGFRm NSCLC.

Eligible Conditions
  • Epidermal Growth Factor Receptor Mutations
  • Protein Kinase Inhibitors
  • Tyrosine Kinase Inhibitor Resistance
  • Epidermal Growth Factor Receptor Deletion
  • Lung Cancer
  • Lung Disease
  • Bronchial Tumors
  • Adenocarcinoma
  • Epidermal Growth Factor Receptor
  • Non-Small Cell Lung Cancer
  • Chemotherapy
  • Tumors
  • Cancer
  • Neurofibromatosis
  • Respiratory Diseases

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
[Phase 1] Determine the maximum tolerated dose (MTD) of BLU-701 monotherapy, BLU-701 in combination with osimertinib, and BLU-701 in combination with platinum-based chemotherapy
[Phase 1] Determine the recommended Phase 2 dose (RP2D) of BLU-701 monotherapy, BLU-701 in combination with osimertinib, and BLU-701 in combination with platinum-based chemotherapy
[Phase 1] Overall safety profile
+1 more
Secondary outcome measures
[Phase 1 and Phase 2] Duration of response (DOR)
[Phase 1 and Phase 2] To characterize the PK profile of BLU-701
[Phase 1] Overall response rate (ORR)
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 2A: BLU-701 as monotherapyExperimental Treatment1 Intervention
Phase 2 expansion group for BLU-701 as monotherapy at a dose determined during Part 1A in patients harboring the EGFR C797X resistance mutation
Group II: Part 1C: BLU-701 with platinum-based chemotherapyExperimental Treatment3 Interventions
BLU-701 in combination with platinum-based chemotherapy (carboplatin and pemetrexed): Carboplatin - IV infusion dosed to target AUC of 5-6 mg/mL min q3w Pemetrexed - IV infusion dosed to 500 mg/m2 q3w
Group III: Part 1B: BLU-701 with osimertinibExperimental Treatment2 Interventions
BLU-701 in combination with osimertinib 40 mg or 80 mg tablets for oral administration
Group IV: Part 1A: BLU-701 as monotherapyExperimental Treatment1 Intervention
Phase 1 dose escalation of BLU-701 as monotherapy at various dose levels
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
FDA approved
Carboplatin
FDA approved
Pemetrexed
FDA approved

Find a site

Who is running the clinical trial?

Blueprint Medicines CorporationLead Sponsor
28 Previous Clinical Trials
6,128 Total Patients Enrolled
1 Trials studying Protein Kinase Inhibitors
190 Patients Enrolled for Protein Kinase Inhibitors

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary goal of this research endeavor?

"The primary aim of this clinical study, which will last up to two and a half years, is to determine the Maximum Tolerated Dose (MTD) of BLU-701 given as monotherapy or in combination with osimertinib or platinum-based chemotherapy. The secondary aims include assessing Overall Survival (OS), Clinical Benefit Rate (CBR) and treatment-triggered modulation of epidermal growth factor receptor pathway biomarkers such as dual specificity phosphatase 6 (DUSP6) and spouty RTK signaling antagonist 4 (SPRY4)."

Answered by AI

Is this experimental protocol still recruiting participants?

"The clinicaltrial.gov portal confirms that this medical trial is actively enrolling patients, with the initial posting having been made on January 13th 2022 and a recent update occurring on June 23rd 2022."

Answered by AI

What is the geographical scope of this experiment?

"Eligible participants can be recruited from several hospitals including Henry Ford Hospital in Detroit, Memorial Sloan Kettering Cancer Center in New York and Sarah Cannon Research Institute in Nashville. Additionally, there are 7 other sites available to enrollees."

Answered by AI

What has BLU-701 been traditionally employed for?

"BLU-701 is optimally used to treat advanced thymoma, but physicians have also seen success in administering it for treating select cases of carcinoma, testicular cancer, neuroendocrine issues, and other medical concerns."

Answered by AI

What is the capacity of participants for this research endeavor?

"Affirmative. As per the details present on clinicaltrials.gov, this investigation is searching for new participants - it was first listed on January 13th 2022 and edited most recently on June 23rd of the same year. 160 volunteers need to be recruited from 7 different research centres."

Answered by AI

What other experiments have been executed with BLU-701 as the focus?

"BLU-701 has been the subject of 1070 studies since its inception in 2002 at H Central de Asturias. At present, 850 trials are ongoing with a number of them being conducted out of Detroit, Michigan."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
(HARMONY) Study of BLU-701 in EGFR-mutant NSCLC
2022. "(HARMONY) Study of BLU-701 in EGFR-mutant NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05153408.
~7 spots leftby Sep 2024
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