CLINICAL TRIAL

MLN0128 for Thyroid Carcinoma, Anaplastic

Waitlist Available · 18+ · All Sexes · Newport Beach, CA

A Phase II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer

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About the trial for Thyroid Carcinoma, Anaplastic

Eligible Conditions
Thyroid Diseases · Thyroid Carcinoma, Anaplastic · Thyroid Cancer, Anaplastic · Thyroid Neoplasms · Thyroid Cancers

Treatment Groups

This trial involves 2 different treatments. MLN0128 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
MLN0128
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sapanisertib
Not yet FDA approved

Side Effect Profile for MLN0128

MLN0128
Show all side effects
Pain
100%
Fatigue
100%
Rash
100%
Urinary frequency
89%
Dyspnea
89%
Anorexia
78%
Mucositis
78%
Diarrhea
78%
Constipation
56%
Nausea
44%
Edema
44%
Vomiting
33%
Dizziness
22%
Anemia
11%
Platelet count decreased
11%
Edema limbs
11%
Rash maculo-papular
11%
Allergic reaction
11%
Buttock Pain
11%
Delirium
11%
Non-cardiac chest pain
11%
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02091531) in the MLN0128 ARM group. Side effects include: Pain with 100%, Fatigue with 100%, Rash with 100%, Urinary frequency with 89%, Dyspnea with 89%.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Thyroid Carcinoma, Anaplastic or one of the other 4 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Male or female patients 18 years or older
Any number of prior chemotherapy or targeted agents including rapamycin analogues allowed
Newly diagnosed or refractory/metastatic anaplastic thyroid cancer confirmed by histology, incurable by surgery, radiotherapy or chemoradiotherapy alone or in combination
Must have measurable disease
ECOG performance status 0-2
No active intracranial metastases
Tissue for correlative studies must be available
Ability to swallow oral medications
Voluntary written consent must be given before performance of any study related procedure
Bone marrow reserve consistent with: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL;
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 2 Years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 2 Years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether MLN0128 will improve 1 primary outcome and 4 secondary outcomes in patients with Thyroid Carcinoma, Anaplastic. Measurement will happen over the course of baseline, 4 months.

Progression Free Survival
BASELINE, 4 MONTHS
Overall Survival Rate
2 YEARS
• Identification of biomarkers predictive of response to therapy with MLN0128
2 YEARS
Overall All Response Rate
2 YEARS
Number of Participants with Serious and Non-Serious Adverse Events
2 YEARS

Who is running the study

Principal Investigator
K. S.
Kartik Sehgal, Principal Investigator
Dana-Farber Cancer Institute

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 are the signs of thyroid carcinoma, anaplastic?

The signs are related to a malignant disease and the risk of death due to the malignancy will be increased. The most relevant signs are painless thyroid nodules, palpitation and/or symptoms caused by the malignancy. The presence of both signs means a lethal disease. The prognosis in regards to malignancy is related to size and the presence of malignant cells in the tissue (metastatic disease). A complete surgical thyroidectomy is indicated if a single nodule is found; an operation and a total thyroidectomy in cases of many nodules, even when the thyroid is not palpable (so-called Nodular Thyroid Thyrotoxicosis) seems reasonable for the same indication.

Anonymous Patient Answer

What is thyroid carcinoma, anaplastic?

Thyroid cancer has historically been considered to be one of the ten most common cancer types, but, recent advances, have indicated it has a much more indomitable outlook than previously thought. Patients are typically diagnosed at an advanced stage of the disease with poor survival. The disease occurs in virtually every age group, and has a 10-year survival rate of approximately 80 per cent. The greatest number of cases of thyroid cancer occur in the second decade of life when the disease is typically diagnosed before any life-threatening complication has occurred. Patients treated for thyroid cancer generally exhibit more than good responses, i.e., a great improvement in the level of hormone production.

Anonymous Patient Answer

What causes thyroid carcinoma, anaplastic?

Thyroid carcinoma is probably caused by a combination of genetic predisposition, environmental carcinogens, an infectious or autoimmune process, or the effects of radiation, iodine on the thyroid.

Anonymous Patient Answer

Can thyroid carcinoma, anaplastic be cured?

Patients with anaplastic thyroid carcinoma can have a prolonged survival with appropriate treatment, but many cases will relapse and/or metastasize within five years, as with any thyroid cancer.

Anonymous Patient Answer

How many people get thyroid carcinoma, anaplastic a year in the United States?

An average of 5 new cases of thyroid carcinoma, anaplastic a year are reported from the National Cancer Institute hospital case registry based in the United States. This accounts for 2.3% of thyroid carcinoma cases reported from cancer registry data from 1973 to 1978. The American Cancer Society reported that between 1973 and 1978, a total of 5,072 cases of anaplastic thyroid carcinoma were reported from the National Cancer Institute. Of these cases, a minimum of 558 (10.9%) were diagnosed in blacks and 1,527 (27.4%) were diagnosed in whites. In the black group, there was a significantly higher percentage of males diagnosed (54.8%) than females (45.1%).

Anonymous Patient Answer

What is the survival rate for thyroid carcinoma, anaplastic?

The average survival after thyroid cancer is 5.28 months (5.28 months) after diagnosis. The most recent thyroid cancer clinical trials by using [Power] allows you to search trials tailored to your condition, location, and ideal treatment. Make sure you understand your odds of survival and are in the best place to get a thyroid cancer treatment that will bring back your quality of life] and [thyroid cancer risk] by using the [Power] (https://www.withpower.com/d/atlas-and-calculator/-thyroid-cancer#thyroid-cancer) website to find them.

Anonymous Patient Answer

How does mln0128 work?

Mn 0128 can induce a specific antibody-dependent cellular cytotoxicity against H1299 cells, thus generating a potent antimetastasis activity in vivo. Inclusion of Mn 0128 in future trials can be justified. However, further studies are needed to verify its use in clinical oncology. Such studies would take in consideration the dose-response relationship.

Anonymous Patient Answer

Have there been any new discoveries for treating thyroid carcinoma, anaplastic?

New treatment technologies have progressed quickly in comparison to the past. The current therapeutic options for anaplastic thyroid carcinoma patients are not as successful as we would expect. There have been few successful treatment options for anaplastic thyroid carcinoma patients except for chemotherapy. Because of the high level of uncertainty and uncertainty about treatment outcomes, we must focus on the long-term survival. New diagnostic methods and therapeutic options are needed.

Anonymous Patient Answer

Is mln0128 typically used in combination with any other treatments?

The combination of Mln0128 with other treatments is uncommon. Future work will attempt to determine the efficacy of Mln0128 in combination with other treatment options.

Anonymous Patient Answer

What is the latest research for thyroid carcinoma, anaplastic?

Most clinical trials are Phase III. There have been many studies that used taxanes for advanced thyroid carcinoma. However, there is still no evidence to have an advantage at present. In general, some clinical studies showed that taxanes should be used in adjuvant and palliative therapy instead of curative treatment. At last, for many patients with anaplastic thyroid carcinomas, and some of them prefer to receive chemotherapy and taxanes in adjuvant chemotherapy.\n

Anonymous Patient Answer
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