Sapanisertib for Advanced Malignant Solid Neoplasm

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Advanced Malignant Solid Neoplasm+4 More
Sapanisertib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether a combination of two drugs may help treat cancer.

See full description

Eligible Conditions

  • Advanced Malignant Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • Recurrent Malignant Solid Neoplasm
  • Refractory Neoplasms

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Advanced Malignant Solid Neoplasm

Study Objectives

This trial is evaluating whether Sapanisertib will improve 5 primary outcomes and 12 secondary outcomes in patients with Advanced Malignant Solid Neoplasm. Measurement will happen over the course of Up to 42 days.

Up to 4 years
Best tumor responses by dose level
Change in treatment regimen due to adverse events
Clinical and laboratory values
Death during study
Elimination half-life (t1/2)
GI symptoms
Incidence and grade of adverse events
Incidence of dose limiting toxicities
Incidence of neurotoxicity
Incidence of serious adverse events
Overall survival by dose level
Progression free survival by dose level
The area under the plasma concentration-time curve (AUC)
The peak plasma concentration (Cmax)
Vital sign measurements
Withdrawals from study due to adverse events
Up to 42 days
Establishment of recommended phase 2 dosage

Trial Safety

Safety Progress

1 of 3

Other trials for Advanced Malignant Solid Neoplasm

Trial Design

1 Treatment Group

Treatment (metformin, sapanisertib)
1 of 1
Experimental Treatment

This trial requires 50 total participants across 1 different treatment group

This trial involves a single treatment. Sapanisertib 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 1 and are in the first stage of evaluation with people.

Treatment (metformin, sapanisertib)Patients receive metformin PO 1-3 times daily on days 1-42 and sapanisertib PO daily on days 15-42 of cycle 1. Patients then receive metformin PO daily and sapanisertib PO daily on days 1-28 of cycle 2 and beyond. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sapanisertib
Not yet FDA approved
Metformin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 4 years for reporting.

Closest Location

M D 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 Advanced Malignant Solid Neoplasm or one of the other 4 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 patients 18 years or older.
Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Female patients who: Are postmenopausal for at least 1 year before the screening visit, OR Are surgically sterile, OR If they are of childbearing potential, agree to practice 1 highly effective method of contraception and one additional effective (barrier) method at the same time, from the time of signing the informed consent through 90 days (or longer as mandated by local labeling [eg USPI, SmPC, etc] after the last dose of study drug, or Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient (Periodic abstinence [e.g, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.) MUST have a negative serum or urine pregnancy test within 7 days of initiating protocol treatment unless prior hysterectomy or menopause (defined as 12 consecutive months without menstrual activity).
CONTINUED FROM #3: Patients should not become pregnant or breastfeed while on this study. The effects of TAK-228 and metformin on the developing human fetus are unknown. Should a woman become pregnant or suspect she is pregnant, she should inform her treatment physician immediately. Male patients, even if surgically sterilized (ie, status post-vasectomy), who: Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, or Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient, as described in #3 above. Agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug.
Patients must have a diagnosis of advanced or metastatic malignancy that is refractory to standard therapies, who have relapsed after standard therapy, or whose cancers have no standard therapy that induces a CR rate of at least 10% or improves survival by at least three months.
Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status </= 1.
Adequate organ function, as specified below, within 7 days before the first dose of study drug: a) Bone marrow reserve consistent with: absolute neutrophil count (ANC) >/= 1.5 x 10^9/L; platelet count >/= 100 x 10^9/L; hemoglobin >/= 9 g/dL without transfusion within 1 week preceding study drug administration; b) Hepatic: total bilirubin </= 1.5 x upper limit of normal (ULN), transaminases (aspartate aminotransferase/serum glutamic oxaloacetic transaminase-AST/SGOT and alanine aminotransferase/serum glutamic pyruvic transaminase-ALT/SGPT) </= 2.5 x ULN (</= 5 x ULN if liver metastases are present); c) Renal: creatinine clearance >/=50 mL/min based either on Cockroft-Gault estimate or based on urine collection (12 or 24 hour); d) Metabolic: fasting serum glucose (</= 130 mg/dL) and fasting triglycerides </= 300 mg/dL.
Ability to swallow oral medications.
Patients with diabetes are allowed and may be on antidiabetic treatment other than Metformin. The diabetes must be under control within normal range (HbA1C </=7%).
Patients must be at least 5 half-lives beyond previous treatment with metformin and currently not taking metformin.

Patient Q&A Section

Have there been any new discoveries for treating cancer?

"Not yet. But the new CRISPR-Cas9 system does have potential to destroy cancer. I would like to see (and maybe, someday I hope, experience) it being used to treat multiple cancers - including leiomyosarcoma - in patients. So where’s Leyo?" - Anonymous Online Contributor

Unverified Answer

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

"About 3.7 million people a year are expected to develop cancer; 1.6 million from lung cancer, 1.3 million from prostate cancer, and 0.8 million from colon cancer. These numbers will increase as the overall US population ages." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"Cancer is an incurable disease that occurs when cells are no longer able to regulate themselves. There are more than 20 common cancer types and there are many rarer types. Most cancers are caused by environmental agents such as tobacco, excessive alcohol use, or chemicals such as the hepatitis B virus. The disease typically arises from normal body cells and the rate of tumour formation is lower in those with good immunity. Tumour cells invade surrounding tissues and set up camps so that they may grow new blood vessels and other nutrients. The exact cause of cancer remains unclear. The disease is not contagious." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"Common treatment for cancer includes radiation, biotherapy, surgery, chemotherapy, and hormonal therapy (HRT). The prognosis of cancer depends on the staging, where the best treatment options are determined by how advanced the cancer is, and treatment options for individuals vary vastly in a given population (or type of cancer). There is no cure or vaccine, and treatment typically involves surgery to remove or destroy cancer cells or tumors.\n" - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"Cancer therapy can prevent cancer symptoms. However, given the present level of cancer control, it is probably impossible to eradicate cancer completely, which indicates that cancer can not be cured but only prevented." - Anonymous Online Contributor

Unverified Answer

What are the signs of cancer?

"The key signs of cancer are nonspecific: the presence of a malignancy, suspicion of cancer, the effects of cancer. Malignancy can be recognised by one of several approaches including a thorough medical examination by a medical practitioner, the observation of the physical signs with the aid of the patient's history and family history, or by using a specific test such as a blood test or scan to detect tumour." - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"The causes of cancer are varied and include genetic (single gene disorders), environmental (environmental carcinogens,) random (mistakes during cell division, or chemical and physical hazards) and infectious (viral, bacterial or parasitic infections) causation. Although cancer may be diagnosed and treated quickly, it still has a high percentage of non-treatable cases that do not respond to treatment. Because cancer affects people of all ages, both male and female, it is difficult to pinpoint when the disease starts, but cancer has no specific age of onset, at least, in people who are alive at the time of diagnosis. If cancer does have a definite age of onset, it does not always occur soon after the disease begins." - Anonymous Online Contributor

Unverified Answer

Does sapanisertib improve quality of life for those with cancer?

"Results from a recent paper suggest that the treatment with SAP has a positive impact on HRQoL and symptoms and this effect seems to be independent from the efficacy of the treatment, as shown by the good tolerability." - Anonymous Online Contributor

Unverified Answer

What does sapanisertib usually treat?

"Panobinostat and sapanisertib are inhibitors of both HDAC1 and HDAC2. Therefore, they exert the antiproliferative activity by interfering with the repression of transcriptional coregulator and histone modifications of the target genes. Findings from a recent study of this study indicate the potential of combining these drugs in the treatment of a broad spectrum of hematological malignancies such as myeloid leukemia, lymphoid leukemia, and Hodgkin lymphoma." - Anonymous Online Contributor

Unverified Answer

How serious can cancer be?

"Results from a recent paper population with a mean age of 67 years and almost 70 years in the first decade of life and the first 30 years of adulthood, nearly a quarter of patients had experienced one or more types of cancer, but one third of the patients who underwent surgery for cancer had died of the disease. While about half of the patients who underwent surgery with curative intent had been cured of the disease, this seemed to be by no means guaranteed. As expected, most fatal cancer could be traced back to smoking – a fact that would only be of significance if smoking were not an absolute impediment to the curative potential of surgery. This should alert us to the reality of cancer, and to the importance of primary prevention." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cancer?

"The majority of patients, on clinical trial assessments, had a poor understanding of randomization and study design and the implications of that. Clinicians should make more effort to make patients more knowledgeable about their options when they are diagnosed with cancer and to help them navigate the options and the treatment options. Patients with cancer are particularly willing to participate in clinical trials, despite the increased risk related to enrollment, but clinicians should maximize their opportunities to educate patients. Understanding, understanding, and respecting patients with cancer and their unique beliefs and experiences about their illness, therapy, and options should always take precedence in clinical trials." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in sapanisertib for therapeutic use?

"The identification of patients responsive to a dose of 150 mg twice daily, the ability to use this dose in combination with capecitabine and a reduced exposure at this dose, together with the potential to use a dose-dependent combination regimen of sapanisertib in combination in patients with metastatic tumors, make sapanisertib a very attractive molecule in the treatment of cancer." - 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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