NCT04439240

Brief Summary

This phase II MATCH treatment trial identifies the effects of AZD4547 in patients whose cancer has genetic changes called FGFR gene alterations. AZD4547 may stop the growth of cancer cells by blocking FGFR proteins which may be needed for cell growth. Researchers hope to learn if AZD4547 will shrink this type of cancer or stop its growth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
12 months until next milestone

Results Posted

Study results publicly available

June 29, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

3 years

First QC Date

June 18, 2020

Results QC Date

May 3, 2021

Last Update Submit

June 8, 2021

Conditions

Advanced LymphomaAdvanced Malignant Solid NeoplasmHematopoietic and Lymphoid Cell NeoplasmRefractory LymphomaRefractory Malignant Solid NeoplasmRefractory Plasma Cell Myeloma

Keywords

FGFRAZD4547NCI-MATCH

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR)

    Overall response rate was defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) among all eligible and treated patients. Best overall response was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. The 90% two-sided binomial exact confidence interval was calculated for ORR.

    Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration

Secondary Outcomes (2)

  • 6-month Progression-free Survival (PFS) Rate

    Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS is determined

  • Progression Free Survival (PFS)

    Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration

Study Arms (1)

Treatment (AZD4547)

EXPERIMENTAL

Patients receive AZD4547 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: FGFR Inhibitor AZD4547

Interventions

FGFR Inhibitor AZD4547DRUG

Given PO

Also known as: AZD4547
Treatment (AZD4547)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol
  • Patients must have FGFR 1-3 mutation or translocation as determined by the MATCH screening assessment
  • Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
  • Patients must have an echocardiogram (ECHO) or a nuclear study (multigated acquisition scan \[MUGA\] or First Pass) within 4 weeks prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) \< institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be \> 50% for the patient to be eligible
  • Patients must have a pre-study eye exam by an ophthalmologist. Patients with current evidence of corneal or retinal disorder/keratopathy are excluded

You may not qualify if:

  • Patients must not have known hypersensitivity to AZD4547 or compounds of similar chemical or biologic composition
  • Patients must not have received prior FGFR specific inhibitors (e.g. BGJ398, erdafitinib, BAY1163877, LY2874455). Prior non-selective FGFR inhibitor treatment (e.g. pazopanib, dovitinib, ponatinib, brivanib, lucitanib, lenvatinib) will be allowed
  • Patients must not have any history of or current evidence of renal or endocrine alterations of calcium/phosphate homeostasis, or history of or current evidence of extensive tissue calcification (by evaluation of the clinician), including but not limited to, the soft tissue, kidneys, intestine, myocardium and lung with the exception of calcified lymph nodes and asymptomatic vascular calcification per investigators' judgment
  • Patients must not be currently using medications that can elevate serum phosphorous and/or calcium levels
  • Medications that increase serum calcium should be avoided. Over the counter calcium supplements, antacids that contain calcium (Tums) and vitamin D supplements (cholecalciferol and ergocalciferol) should be avoided. Prescription medications including lithium, hydrochlorothiazide and chlorthalidone must be used with caution
  • Medications that increase serum phosphate should be avoided. Over the counter laxatives that contain phosphate such as Fleets Oral or Fleets enema and Miralax should be avoided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ECOG-ACRIN Cancer Research Group

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (1)

  • Chae YK, Hong F, Vaklavas C, Cheng HH, Hammerman P, Mitchell EP, Zwiebel JA, Ivy SP, Gray RJ, Li S, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Mansfield A, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase II Study of AZD4547 in Patients With Tumors Harboring Aberrations in the FGFR Pathway: Results From the NCI-MATCH Trial (EAY131) Subprotocol W. J Clin Oncol. 2020 Jul 20;38(21):2407-2417. doi: 10.1200/JCO.19.02630. Epub 2020 May 28.

    PMID: 32463741RESULT

Related Links

MeSH Terms

Conditions

Hematologic NeoplasmsLymphomaMultiple Myeloma

Interventions

AZD4547

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Results Point of Contact

Title
Study Statistician
Organization
ECOG-ACRIN Cancer Research Group
eatrials@jimmy.harvard.edu
617-632-3012

Study Officials

  • Young Kwang Chae

    ECOG-ACRIN Cancer Research Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2020

First Posted

June 19, 2020

Study Start

May 31, 2016

Primary Completion

June 6, 2019

Study Completion

June 30, 2020

Last Updated

June 29, 2021

Results First Posted

June 29, 2021

Record last verified: 2021-06

Locations

US(1)