Capivasertib for Lymphoma, Diffuse

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Research Site, Seo-Gu, Korea, Republic of
Lymphoma, Diffuse+3 More
Capivasertib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a drug called capivasertib can improve the outcome of people with relapsed or refractory non-Hodgkin's lymphoma.

See full description

Eligible Conditions

  • Lymphoma, Diffuse
  • Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lymphoma, Diffuse

Study Objectives

This trial is evaluating whether Capivasertib will improve 1 primary outcome and 12 secondary outcomes in patients with Lymphoma, Diffuse. Measurement will happen over the course of From Cycle 1 (28-day treatment cycle) Day 1 until documented response (also until PD/Death for those who never respond) [Assessed Up to 1.6 Years].

Week 24
Change from baseline in health-related quality of life as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Year 6
Proportion of participants reporting symptomatic adverse events (AEs) and overall side effect burden at each time point as measured by Patient Global Impression of Treatment Tolerability (PGI-TT)
Year 6
Change in National Cancer Institute patient-reported outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) symptoms
Proportion of patients reporting symptomatic AEs and overall side effect burden at each time point as measured by patient-reported outcomes common terminology criteria for adverse events (PRO-CTCAE)
Day 1
Plasma concentration of capivasertib post-dose
Year 6
Time to objective response (TTR)
Day 22
Observed lowest drug concentration reached before the next dose is administered (Ctrough) of capivasertib
Year 6
Number of participants with AEs and Serious adverse events
Year 6
Duration of response (DoR)
Progression-free survival
Year 6
Overall survival (OS)
Year 6
Time to first subsequent therapy or death (TFST)
Year 6
Proportion of participants with objective response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Lymphoma, Diffuse

Trial Design

1 Treatment Group

Capivasertib monotherapy
1 of 1
Experimental Treatment

This trial requires 272 total participants across 1 different treatment group

This trial involves a single treatment. Capivasertib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Capivasertib monotherapy
Drug
Participants with R/R FL, R/R MZL, and R/R MCL will receive capivasertib orally until progression of disease (PD) or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capivasertib
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: until death due to any cause (assessed up to 1.6 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly until death due to any cause (assessed up to 1.6 years) for reporting.

Closest Location

Research Site - Victoria, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Lymphoma, Diffuse or one of the other 3 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:
Participants must be ≥ 18 years of age, at the time of signing the informed consent
Eastern Cooperative Oncology Group performance status ≤ 2
Life expectancy > 6 months
Female participants must not be breast-feeding and must have a negative pregnancy test (serum) prior to start of dosing
Histologically confirmed diagnosis of FL Grade 1, 2, or 3a as assessed by investigator or local pathologist
Current need for systemic treatment based on the Investigator's opinion
Relapsed, progressed or refractory (defined as failure to achieve at least a partial response [PR]) after at least 2 prior systemic lines of therapy (including anti-CD20 monoclonal antibody [mAb] and an alkylating agent)
Bi-dimensionally measurable disease on cross sectional imaging by computed tomography (CT) or magnetic resonance imaging (MRI) with at least one nodal lesion > 1.5 cm in the long axis or at least one extranodal lesion > 1 cm in long axis.
Histologically confirmed MZL including splenic, nodal, and extranodal subtypes as assessed by investigator or local pathologist
Relapsed, progressed or refractory (defined as failure to achieve at least a PR) after at least 2 prior systemic lines of therapy (including at least one anti-CD20mAb directed regimen either as monotherapy or as chemoimmunotherapy; Helicobacter pylori eradication and radiation therapy alone will not be considered a systemic treatment regimen)

Patient Q&A Section

Have there been other clinical trials involving capivasertib?

"Capivasertib appears to be well tolerated in subjects with relapsed or refractory indolent non-Hodgkin's lymphomas. Given its unique mechanism of action, this agent may represent a valid therapeutic option for patients with indolent NHLs and warrants further investigation." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of lymphoma?

"1. The main cause of lymphoma is not HIV infection itself, but rather its complications. 2. The two types of lymphomas which cause the highest mortality rates are those caused by Epstein Barr Virus (EBV) and Kaposi's Sarcoma-associated herpesvirus (KSHV). 3. EBV causes all forms of B-cell lymphomas. 4. Putative viral agents include human T-lymphotropic viruses (HTLV1 and HTLV2), human parvoviruses (B19 and HCMV), and other viruses. 5. A combination of genetic predisposition and environmental factors may contribute to lymphoma development. 6." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for lymphoma?

"Survival rates vary depending upon staging and type of lymphoma, and the disease responds well to treatment. In general, survival rates for follicular lymphomas are higher than those for diffuse large B-cell lymphomas. For patients who are diagnosed early, have been treated with chemotherapy or radiotherapy, and receive maintenance therapy, 5 year overall survival is approximately 85%. However, for patients who have advanced disease and no treatment, only one quarter survive more than 5 years. There are also differences in survival between the genders. Women tend to live longer than men." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets lymphoma?

"The mean age someone with lymphoma gets the disease is 64 years old for HL and 58 years old for NHL. About 50% of patients diagnosed with NHL get the disease before 55 years old. About 32% of patients diagnosed with HL get the disease before 65 years old. Patients with high grade B cell lymphomas tended to have a higher mean age at diagnosis than patients with low grade B cell lymphomas." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing lymphoma?

"The odds of developing lymphoma increases for those who have more than 10 years-old children. However, the odds also increase among adults who have more than one first degree relative with lymphoma. Recent findings suggest that genetic predisposition may play a role in determining risk of developing lymphoma in individuals." - Anonymous Online Contributor

Unverified Answer

What is capivasertib?

"Capivasertib was well tolerated, but did not improve progression-free survival compared to placebo in patients with relapsed or refractory follicular lymphoma. Overall survival data were inconclusive due to early closure of the trial. Additional studies are needed to confirm these results before capivasertib can be recommended as a treatment option. Clinicaltrials.gov identifier: NCT01797636." - Anonymous Online Contributor

Unverified Answer

What is lymphoma?

"In this article we describe the different types of lymphomas encountered in the Indian population and provide guidelines for the diagnosis and management of these diseases." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in capivasertib for therapeutic use?

"This year, the FDA approved capivasertib as a treatment for patients with relapsed or refractory acute lymphoblastic leukemia (ALL) who have received prior systemic therapy. In December 2017, Pfizer and Bristol-Myers Squibb announced they had reached a deal to acquire the global market rights to capivasertib from Pharmacia & Upjohn for up to $1 billion, with $900 million upfront and a further $900 million contingent upon successful regulatory submissions. In April 2018, Pfizer announced it would be paying $2.9 billion over two years to acquire the existing global sales and marketing rights to capivasertib from Pharmacia & Upjohn." - Anonymous Online Contributor

Unverified Answer

What are the signs of lymphoma?

"Most patients with lymphoma should be evaluated with imaging studies. A CT scan is preferred over MRI as it shows more anatomically relevant data. Bone marrow aspirations are recommended to evaluate for involvement of bone marrow by lymphoma. Imaging is also used to evaluate for other masses that could mimic lymphoma. Depending on the nature of the mass, PET/CT may be helpful." - Anonymous Online Contributor

Unverified Answer

How serious can lymphoma be?

"In summary, lymphoma is a deadly disease, especially when the patient has disseminated disease. It is important that patients with a history of lymphoma are aware of their high risk of developing secondary cancers in their remaining lifetime. Patients with multiple extranodal sites of disease should be considered for more intensive surveillance and treatment regimes than those with single sites, even if the course of the disease is apparently benign." - Anonymous Online Contributor

Unverified Answer

Has capivasertib proven to be more effective than a placebo?

"Capivasertib was efficacious in patients with advanced NSCLC. The drug did not cause any significant harm in terms of serious side effects. Results from a recent paper provides further evidence that capivasertib may be an effective treatment option for patients with advanced NSCLC." - Anonymous Online Contributor

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