Study of Crenolanib, a Selective and Potent Inhibitor of PDGFR, for the Treatment of Adult Gliomas

NCT01229644 | Terminated Phase 2

• 1 other identifier: ARO-BRE-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the antitumor efficacy of crenolanib (CP-868,596) in patients with recurrent high grade glioma and in patients with low grade glioma.

Conditions

Glioma

Keywords

Glioma; Brain Cancer; Recurrent glioma; Low grade glioma; PDGFR Inhibitor; Crenolanib (CP-868,596); Neo-adjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• The primary end-point is overall response rate

  Tumor response will be assessed by MRI scans every 2 months until disease progression

Secondary Outcomes (1)

• The secondary end-point for this study is PFS

  6-months and 12-months PFS will be measured

Study Arms (3)

Cohort A

EXPERIMENTAL

Adult newly diagnosed glioma (both low and high grade) patients, who are able to to take Crenolanib (CP-868,596) for at least 3 days prior to surgical resection.

Drug: Crenolanib (CP-868,596)

Cohort B

EXPERIMENTAL

Adult patients with recurrent high grade glioma, including patients treated with bevacizumab. Patients are treated with Crenolanib (CP-868,596) continuously until they fulfill one of the criteria for study discontinuation.

Drug: Crenolanib (CP-868,596)

Cohort C

EXPERIMENTAL

Adult patients with biopsy proven low grade glioma who have residual measurable disease. Patients are treated with Crenolanib (CP-868,596) continuously until they fulfill one of the criteria for study discontinuation.

Drug: Crenolanib (CP-868,596)

Interventions

Crenolanib (CP-868,596) DRUG

Highly potent inhibitor of both PDGFR receptors alpha and beta

Also known as: Crenolanib Besylate

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, of any racial or ethnic group
• Age 18 years or older
• Patient able and willing to provide informed consent
• Adequate kidney and liver function
• Karnofsky Performance Status ≥ 70%
• Negative serum pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
• Imaging suggestive of malignant glioma (Cohort A)
• History of glioma with measurable disease by MRI (Cohorts B and C)
• Histologically confirmed GBM with radiographic progression (Cohort B). These patients are permitted to have had prior therapy including surgery, radiation, Temozolomide, irinotecan and bevacizumab.
• Histological confirmation of a low-grade glioma (Cohort C)

You may not qualify if:

• Patient unable to provide informed consent (comatose or markedly cognitively impaired)
• Female participants that are pregnant or breastfeeding
• Any other concurrent anticancer therapy
• Karnofsky Performance status \< 70%
• Any other concurrent investigational agents within 4 weeks of start of study drug
• Patients with liver disease (known or active Hepatitis B or C; steatohepatitis; cirrhosis)
• Hepatic:
• Bilirubin greater than 1x the upper limit of normal
• Transaminases greater than 1x the upper limit of normal
• Abnormal renal function
• o Serum creatinine \>1.7 ng/dl
• Patients on concomitant medications that induce or inhibit CYP450, such as enzyme inducing anti-epileptic drugs (EIAEDs) (Appendix III) and troglitazone

Sponsors & Collaborators

• Arog Pharmaceuticals, Inc.: lead

Study Sites (1)

Harold Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Elizabeth A. Maher1, Clinton Stewart2, Kimmo Hatanpaa1, Jack Raisanen1, Tomoyuki Mashimo1, Xiao-Li Yang1, Chaitanya Muralidhara3, Christopher Madden1, Abhijit Ramachandran3, Bruce Mickey1, Robert Bachoo1, 1University of Texas Southwestern Medical Center, Dallas, TX, 2St. Jude's Children's Research Hospital, Memphis, TN, 3AROG Pharmaceuticals, LLC, Dallas, TX Neoadjuvant administration of the potent PDGFR inhibitor, crenolanib, to malignant gliomas at initial diagnosis: does it hit the target?

  BACKGROUND

Related Links

• Harold C. Simmons Cancer Center at UT Southwestern is the only NCI-designated Cancer Center in North Texas

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Interventions

crenolanib

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Elizabeth Maher, M.D., Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 28, 2010
• Study Start: April 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 5, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)