Icapamespib for Relapse

Phase-Based Estimates
1
Effectiveness
1
Safety
MD Anderson Cancer Center, Houston, TX
+7 More
Icapamespib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Relapse

Study Summary

Study of Icapamespib (PU-AD) in Patients With Recurrent Malignant Glioma

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Eligible Conditions

  • Relapse
  • Astrocytoma
  • Glioma
  • Glioblastoma
  • Recurrence
  • Grade 3 or 4 Astrocytoma
  • Glioblastoma Surgery
  • Recurrent Glioblastoma Multiforme (GBM)
  • Grade 3 Isocitrate Dehydrogenase (IDH) Wildtype Astrocytoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Icapamespib will improve 3 primary outcomes in patients with Relapse. Measurement will happen over the course of 7-14 days post surgery.

7-14 days post surgery
Icapamespib Plasma Concentration at Time of Surgery
Month 6
Incidence and severity of adverse events
Maximum Tolerated Dose (MTD)/Coverage with evidence development (CED)/recommended phase 2 dose (RP2D) (Part 1 Only

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
dose expansion cohort

This trial requires 48 total participants across 2 different treatment groups

This trial involves 2 different treatments. Icapamespib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

dose expansion cohort
Drug
dose expansion cohort to further evaluate the recommended Phase 2 dose (RP2D)
20 mg Icapamespib cohort
Drug
Icapamespib will be administered orally once daily for each 28-day cycle. The initial dose in this trial will be 20 mg

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months for reporting.

Closest Location

MD Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Relapse or one of the other 7 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female subjects having histologically confirmed IDH wildtype glioblastoma (Parts 1 and 2), or grade 3 or 4 IDH mutant astrocytoma (Part 1 only) per WHO criteria
Subjects must be at 1st, 2nd, or 3rd recurrence (Part 1) or 1st or 2nd recurrence (Part 2) and with at least 5 subjects clinically requiring reoperation for tumor progression (Part 2). show original
You have measurable disease as defined by RANO (1 cm × 1 cm minimum dimensions, at least 12 weeks after final radiotherapy dose; if new disease is outside radiotherapy field, <4 weeks is acceptable). show original
Cranial MRI performed within 14 days prior to study entry.
You must be aged 18 years or older. show original
Karnofsky performance status of >60 at screening
Adequate bone marrow, liver and renal functions (tests must be performed within 14 days prior to enrollment).The following laboratory values must be documented within 3 days prior to the first dose of study drug Absolute neutrophil count (ANC) ≥1.5 × 109/L Platelet count ≥100 × 109/L Estimated creatinine clearance (CrCl) >60 mL/min by Cockcroft-Gault formulation Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 × the upper limit of normal (ULN) Total bilirubin ≤1.5 × ULN (unless due to Gilbert's syndrome) Serum albumin ≥2.8 g/dL International normalized ratio (INR) <1.5 (except subjects maintained on anticoagulant medications)
You are a female of childbearing potential. show original
Willingness to follow highly effective means of contraception
Able and willing to give informed consent

Patient Q&A Section

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

What is relapse?

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Relapse in an untreated brain tumour patient is associated with specific MR characteristics. Relapse is an ominous complication of the initial treatment of an untreated brain tumour, and the potential clinical impact of its timely detection is considerable.

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What are the signs of relapse?

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Some signs of relapse include changes to the patient’s usual eating, sleeping and exercising patterns. They may also have changes to emotional and social functioning, including depression and problems with concentration and attention.\n

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Can relapse be cured?

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Patients who are cured by the remission criteria experience a relapse rate of less than 5% per year. However, patients, as well as their spouses and social partners, feel that the patients' disability is increased significantly by the relapse during a 5-year period.

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What causes relapse?

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The most common cause of recurrent invasive [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is local disease recurrence/regress. In breast cancer survivors, treatment failure is common; only 10% of the women with recurrent breast cancer were free of local disease for five years after initial breast treatment. The most common sites of recurrence are: axilla/breast/chest/skin recurrence (46%); local recurrence only (11%); recurrence in other organ sites (21%); and distant (sentinel site or metastasis) recurrence (7%).

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How many people get relapse a year in the United States?

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Relapse rates following cannabis use (12-24 hours later following abstinence) were very high (42% to 89%, depending on method of relapse definition). Relapse rates after cannabis use are highest among persons with a history of relapse. Relapse is an important issue to consider before initiating cannabis use and after cannabis use for other reasons. Future efforts to minimize relapse following cannabis use warrant continuing efforts to implement relapse prevention counseling and strategies in clinical settings like publicly funded HIV clinics and substance abuse treatment programs.

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What are common treatments for relapse?

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Relapse prevention can be improved by incorporating relapse treatment in the management of HPV disease. We recommend addressing the psychosocial and social aspects related to emotional adjustment as well as smoking cessation, which might increase the patient's willingness for relapse treatment.

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Does relapse run in families?

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Relapse was strongly associated with family history of disease in univariate analysis but no difference was found when adjusting for familial history of disease in multivariate analysis. This may be possibly due to the nature of a family history in patients with sporadic disease.

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Has icapamespib proven to be more effective than a placebo?

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ICAP was more effective than the placebo in terms of improvement of TTP and PFS and was significantly more active than placebo in terms of PFS and OS.

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How quickly does relapse spread?

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The relapse was mainly located in the lower limbs. The relapse was not found within one month (n=24; 14%) but was after 2 months (n=41; 26%; statistically significant). Although no statistically significant difference was detected, one patient (4.6%) continued to relapse throughout the 6 months of follow-up and another patient (5.4%) was still in partial remission at 6 months. After 9 months, the relapse was only in the lower limbs. Relapse was not found in the lower limbs after one or two months (n=46; 30%; statistically significant). After 9 months, the relapse was also in both limbs (n=42; 28%; non-significant).

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Is icapamespib typically used in combination with any other treatments?

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This article presents the typical use of icapamespib in combination with other medications for the treatment of HR-positive/HER2-positive advanced/[metastatic breast cancer](https://www.withpower.com/clinical-trials/metastatic-breast-cancer), metastatic/localized advanced ovarian, or recurrent/persistent platinum-resistant uterine/serous ovarian cancer, and as a postprogression treatment of metastatic breast cancer. When combined with a taxane, icapamespib is a viable treatment option for women with advanced breast cancer.

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What are the chances of developing relapse?

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The risk of relapse in our patients is not predicted by clinical features. Relapse of cancer and lymphoma after [treatment termination] may also be predicted by patient age, tumor site, histologic subtype, and presence of B or T cell lymphoproliferation, but this has not been adequately reported in the literature, and the conclusions that can be drawn need to be clarified.

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