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Clinical Trial 20248

Cancer Type: Neurologic Oncology
Study Type: Treatment
NCT#: NCT04047303

Phase: Phase I
Prinicipal Investigator:

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Overview

Study Title

A Phase 1, Open-Label Study to Assess The Pharmacokinetics, Pharmacodynamics and Central Nervous System (CNS) Penetration of CC-90010 in Preoperative Subjects with Progressive or Recurrent who Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma and Recurrent Glioblastoma Scheduled for Resection

Summary

CC-90010-GBM-001 is a multi-center, open-label study to assess the pharmacokinetics (PK), pharmacodynamics (PD) and CNS penetration of CC-90010 following short-term interval therapy (4 daily doses ) prior to surgery, in patients with progressive or recurrent WHO Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma and recurrent Glioblastoma who have failed radiation and chemotherapy, and who are candidates for surgical tumor resection as part of their salvage regimen (planned salvage resection).

Objective

The primary objectives of the study are:  To measure the concentration of CC-90010 in an exploratory manner in surgically resected brain tumor tissue (within contrast enhancing tumor as well as non-enhancing tumor, wherever possible) at a single time point following oral dosing, and to compare this with the concentration of CC-90010 in plasma at the same time point  To characterize the pharmacokinetics (PK) of CC-90010 in plasma The secondary objective is:  To monitor the safety and tolerability of single agent CC-90010 in subjects with progressive or recurrent WHO Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma and recurrent Glioblastoma undergoing planned salvage resection

Treatments

Therapies

Medications

CC-90010 ()

Inclusion Criteria

  • Men and women ≥ 18 years of age,) with recurrent or progressive WHO Grade II Diffuse Astrocytoma, Grade III Anaplastic Astrocytoma or recurrent WHO Grade IV Glioblastoma .
  • Participants must have previously completed standard or a hypofractionated course of radiation therapy and have been exposed to procarbazine, lomustine and vincristine (for Grade II Astrocytoma), including those who have progressed on (or not been able to tolerate due to medical comorbidities or unacceptable toxicity) standard anticancer therapy, with radiation completed > 12 weeks prior to the first CC-90010 dose (Day 1).
  • Participant must be in first or second recurrence.
  • Participant must have archival tumor tissue suitable for genetic testing and must give permission to access and test the tissue.
  • Participant is considered an appropriate candidate for surgical resection of the recurrent tumor tissue (salvage resection).
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.
  • Participant must meet laboratory values as outlined per protocol at screening.
  • Females and males must agree to contraceptive methods and avoid conceiving throughout study and up to 3 months (females) and 106 days (males) following last dose of CC-90010.

  • Exclusion Criteria

  • Participant has received anti-cancer therapy (either approved or investigational) within ≤ 4 weeks (6 weeks for nitrosoureas) or 5 half-lives, whichever is shorter, prior to starting CC-90010. If Participant received prior immunotherapy (immune checkpoint inhibitor, vaccine, etc.), a 2 week wash-out is required. For a Participant treated with the Optune-TTF device, a 2 day period without use is required.
  • Toxicities resulting from prior chemotherapy, surgery, or radiotherapy must have resolved to ≤ NCI CTCAE (version 5.0) Grade 1 prior to starting CC-90010 treatment (with the exception of Grade 3 alopecia).
  • Participant has undergone major surgery ≤ 4 weeks or minor surgery ≤ 2 weeks prior to starting CC-90010 or Participant who has not recovered from surgery.
  • Participant has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) ≥ NCI CTCAE Grade 2, despite medical management, or any other significant GI disorder that could affect the absorption of CC-90010.
  • Participant with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and GI tract hemorrhages.
  • Evidence of CNS hemorrhage on baseline MRI or CT scan (except for post-surgical, asymptomatic Grade 1 hemorrhage that has been stable for at least 4 weeks).
  • Participant who requires increasing doses of corticosteroids to treat symptomatic cerebral edema within 7 days of study therapy.
  • Known symptomatic acute or chronic pancreatitis.
  • Impaired cardiac function or clinically significant cardiac diseases, including any of the following: LVEF > Pregnant or nursing females.
  • Known HIV infection.
  • Known chronic active hepatitis B or C virus (HBV, HCV) infection.
  • Participant with a requirement for ongoing treatment with therapeutic dosing of anticoagulants or for ongoing prophylactic anticoagulation. Low dose low molecular weight heparin for catheter maintenance is allowed.
  • History of concurrent second cancers requiring active, ongoing systemic treatment.
  • Evidence of history of bleeding diathesis.
  • Participant with known prior episodes of non-arteritic anterior ischemic optic neuropathy (NAION) should be excluded from the study. CC-90010 should be used with caution in Participants with retinitis pigmentosa.
  • Participant with poor bone marrow reserve as assessed by Investigator such as in the following condition: Requiring regular hematopoietic support

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.