NCT01243346

Brief Summary

This Phase II study is designed to evaluate the antitumor efficacy and pharmacokinetics of crenolanib (CP-868,596) in patients with D842-related mutant metastatic GIST.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2011

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

3.3 years

First QC Date

November 17, 2010

Last Update Submit

June 26, 2018

Conditions

D842-related Mutant GIST

Keywords

Gastrointestinal Stromal TumorPDGFR InhibitorCrenolanib (CP-868,596)

Outcome Measures

Primary Outcomes (1)

  • The primary end-point is overall response rate

    To determine the response rate of patients with advanced D842V mutant GIST, when treated with Crenolanib (CP-868,596). Response will primarily be determined by RECIST criteria

    1.5 years

Secondary Outcomes (3)

  • Progression free survival rate

    6 months

  • Obtain toxicity information

    1 year

  • PKPD analysis

    1 year

Study Arms (1)

Crenolanib (CP-868,596)

EXPERIMENTAL
Drug: Crenolanib besylate (CP-868,596-26), Dose: 140mg BID

Interventions

Crenolanib besylate (CP-868,596-26), Dose: 140mg BIDDRUG

Highly potent inhibitor of both PDGFR receptors alpha and beta

Crenolanib (CP-868,596)

Eligibility Criteria

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

You may qualify if:

  • Male or female, of any racial or ethnic group
  • Age 18 years or older
  • Life expectancy of greater than 12 weeks
  • Patient able and willing to provide informed consent
  • Normal liver function, defined as AST and ALT ≤2.5x ULN, and Total Bilirubin ≤ 2x ULN.
  • Total creatinine ≤ 1.5x ULN
  • ECOG Performance Status 0 - 2 (Appendix II)
  • Patients must have histologically or cytologically confirmed GIST with a D842-related mutation or deletion on the PDGFRA gene
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan. See Section 10.1.2 for the evaluation of measurable disease.
  • Patients must have recovered from any prior therapy and completed the minimum of, either 5 half-lives of prior therapy or 2 weeks must have elapsed since prior treatment

You may not qualify if:

  • Patient unable to provide informed consent
  • ECOG Performance status \> 2
  • Any concurrent anticancer therapy, immunotherapy, or hormonal therapy.
  • Any other investigational agents taken within 2 weeks of start of study drug or if study drug will commence within 5 half-lives of prior therapy
  • Patients with known or active Hepatitis B or C; liver cirrhosis.
  • Patients with active fungal, viral, and bacterial infections
  • Positive serum pregnancy test
  • Pregnant or lactating women
  • Patients on concomitant medications that induce or inhibit CYP3A4 (Appendix III)
  • Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Knight Cancer Institute, Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Related Publications (1)

  • Heinrich MC, Griffith D, McKinley A, Patterson J, Presnell A, Ramachandran A, Debiec-Rychter M. Crenolanib inhibits the drug-resistant PDGFRA D842V mutation associated with imatinib-resistant gastrointestinal stromal tumors. Clin Cancer Res. 2012 Aug 15;18(16):4375-84. doi: 10.1158/1078-0432.CCR-12-0625. Epub 2012 Jun 27.

    PMID: 22745105BACKGROUND

Related Links

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Margaret von Mehren, MD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

  • Michael C Heinrich, MD

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 17, 2010

First Posted

November 18, 2010

Study Start

April 1, 2011

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

US(2)