metformin has been researched along with Mucositis in 2 studies
Metformin: A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)
metformin : A member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1.
Mucositis: An INFLAMMATION of the MUCOSA with burning or tingling sensation. It is characterized by atrophy of the squamous EPITHELIUM, vascular damage, inflammatory infiltration, and ulceration. It usually occurs at the mucous lining of the MOUTH, the GASTROINTESTINAL TRACT or the airway due to chemical irritations, CHEMOTHERAPY, or radiation therapy (RADIOTHERAPY).
| Excerpt | Relevance | Reference |
|---|---|---|
| "Nondiabetic patients with LAHNSCC were enrolled in the current study to receive escalating doses of metformin and CRT based on the modified toxicity probability interval design." | 2.94 | Phase 1 dose-finding study of metformin in combination with concurrent cisplatin and radiotherapy in patients with locally advanced head and neck squamous cell cancer. ( Desai, J; Desai, PB; Gulati, S; Gutkind, JS; Jandarov, R; Mierzwa, M; Molinolo, A; Morris, JC; Palackdharry, SM; Riaz, MK; Sadraei, NH; Takiar, V; Wise-Draper, TM; Zhu, Z, 2020) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 1 (50.00) | 24.3611 |
| 2020's | 1 (50.00) | 2.80 |
| Authors | Studies |
|---|---|
| Gulati, S | 1 |
| Desai, J | 1 |
| Palackdharry, SM | 1 |
| Morris, JC | 1 |
| Zhu, Z | 1 |
| Jandarov, R | 1 |
| Riaz, MK | 1 |
| Takiar, V | 1 |
| Mierzwa, M | 1 |
| Gutkind, JS | 1 |
| Molinolo, A | 1 |
| Desai, PB | 1 |
| Sadraei, NH | 1 |
| Wise-Draper, TM | 1 |
| Liu, X | 1 |
| Lorusso, P | 1 |
| Mita, M | 1 |
| Piha-Paul, S | 1 |
| Hong, DS | 1 |
| Fu, S | 1 |
| McQuinn, L | 1 |
| Asatiani, E | 1 |
| Doyle, LA | 1 |
| Chen, HX | 1 |
| Hess, KR | 1 |
| Kurzrock, R | 1 |
| Naing, A | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Phase I Study of Temsirolimus in Combination With Metformin in Patients With Advanced Cancers[NCT01529593] | Phase 1 | 87 participants (Actual) | Interventional | 2012-03-26 | Active, not recruiting | ||
| Phase I Dose Escalation Trial of MEK1/2 Inhibitor MSC1936369B Combined With Temsirolimus in Subjects With Advanced Solid Tumors[NCT01378377] | Phase 1 | 33 participants (Actual) | Interventional | 2011-05-27 | Terminated (stopped due to The trial was stopped due to the toxicities observed with the combination of pimasertib and temsirolimus.) | ||
| Phase I Study of IMC-A12 (NSC# 742460) in Combination With Temsirolimus CCI-779 (NSC# 683864) in Patients With Advanced Cancers[NCT00678769] | Phase 1 | 72 participants (Actual) | Interventional | 2008-05-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
DLT was defined as any of the following toxicities graded as per National Cancer Institute (NCI) common terminology criteria for adverse events (NCI CTCAE v4.0) encountered within cycle 1 of treatment at any dose level and judged not to be related to the underlying disease or concomitant medications. A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation would expose subjects to unacceptable risk; any Grade >=3 non-hematological toxicity except Grade 3 asymptomatic increases in liver function tests, diarrhea, nausea or vomiting with duration <= 48 hours and alopecia; Grade 4 neutropenia of >5 days duration or febrile neutropenia of >1 day duration; Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia; any treatment interruption >2 weeks due to adverse events; any severe, impairing daily functions or life-threatening, complication or abnormality not defined in NCI-CTCAE that is attributable to the therapy. (NCT01378377)
Timeframe: Up to 21 Days (within Cycle 1)
| Intervention | subjects (Number) |
|---|---|
| Pimasertib 45 mg+Temsirolimus 12.5 mg | 0 |
| Pimasertib 45 mg+Temsirolimus 25 mg | 7 |
| Pimasertib 75 mg+Temsirolimus 25 mg | 2 |
An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. The TEAEs were those events that occur between first dose of trial treatment and up to 30 days after last dose of the trial treatment that were absent before treatment or that worsened relative to pretreatment state. (NCT01378377)
Timeframe: From the start of the trial treatment until data cut-off date (23 February 2012)
| Intervention | subjects (Number) |
|---|---|
| Pimasertib 45 mg+Temsirolimus 12.5 mg | 4 |
| Pimasertib 45 mg+Temsirolimus 25 mg | 23 |
| Pimasertib 75 mg+Temsirolimus 25 mg | 6 |
Clearance (CL) of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. The CL obtained after oral dose (CL/F) was influenced by the fraction of the dose absorbed (bioavailability). Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | liter/hour (Median) |
|---|---|
| Non-DDI: Day 8 | |
| Pimasertib 45 mg+Temsirolimus 25 mg (Non-DDI) | 64.31 |
| Pimasertib 75 mg+Temsirolimus 25 mg (Non-DDI) | 53.6 |
Clearance (CL) of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. The CL obtained after oral dose (CL/F) was influenced by the fraction of the dose absorbed (bioavailability). Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | liter/hour (Median) | |
|---|---|---|
| DDI: Day 1 | DDI: Day 9 | |
| Pimasertib 45 mg+Temsirolimus 12.5 mg (DDI) | 81.25 | 71.99 |
| Pimasertib 45 mg+Temsirolimus 25 mg (DDI) | 54.36 | 55.9 |
The t1/2 was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | hour (Median) |
|---|---|
| Non-DDI: Day 8 | |
| Pimasertib 45 mg+Temsirolimus 25 mg (Non-DDI) | 7.746 |
| Pimasertib 75 mg+Temsirolimus 25 mg (Non-DDI) | 5.712 |
The t1/2 was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | hour (Median) | |
|---|---|---|
| DDI: Day 1 | DDI: Day 9 | |
| Pimasertib 45 mg+Temsirolimus 12.5 mg (DDI) | 5.915 | 6.08 |
| Pimasertib 45 mg+Temsirolimus 25 mg (DDI) | 5.886 | 5.896 |
The t1/2 was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | hour (Median) |
|---|---|
| Non-DDI: Day 8 | |
| Pimasertib 45 mg+Temsirolimus 25 mg (Non-DDI) | 29.08 |
| Pimasertib 75 mg+Temsirolimus 25 mg (Non-DDI) | 10.42 |
The t1/2 was defined as the time required for the plasma concentration of drug to decrease 50% in the final stage of its elimination. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | hour (Median) | |
|---|---|---|
| DDI: Day 9 | DDI: Day 16 | |
| Pimasertib 45 mg+Temsirolimus 12.5 mg (DDI) | 25.57 | 20.62 |
| Pimasertib 45 mg+Temsirolimus 25 mg (DDI) | 13.2 | 19.14 |
Volume of distribution (Vz) was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The Vz after oral dose (Vz/F) was influenced by the fraction absorbed. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | liter (Median) |
|---|---|
| Non-DDI: Day 8 | |
| Pimasertib 45 mg+Temsirolimus 25 mg (Non-DDI) | 760.6 |
| Pimasertib 75 mg+Temsirolimus (TEM) 25 mg (Non-DDI) | 416.5 |
Volume of distribution (Vz) was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. The Vz after oral dose (Vz/F) was influenced by the fraction absorbed. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | liter (Median) | |
|---|---|---|
| DDI: Day 1 | DDI: Day 9 | |
| Pimasertib 45 mg+Temsirolimus 12.5 mg (DDI) | 691.3 | 517.6 |
| Pimasertib 45 mg+Temsirolimus 25 mg (DDI) | 536.5 | 519.5 |
The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | hour*nanogram/milliliter (Median) |
|---|---|
| Non-DDI: Day 8 | |
| Pimasertib 45 mg+Temsirolimus 25 mg (Non-DDI) | 4026 |
| Pimasertib 75 mg+Temsirolimus 25 mg (Non-DDI) | 2194 |
The AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | hour*nanogram/milliliter (Median) | |
|---|---|---|
| DDI: Day 9 | DDI: Day 16 | |
| Pimasertib 45 mg+Temsirolimus 12.5 mg (DDI) | 2452 | 2006 |
| Pimasertib 45 mg+Temsirolimus 25 mg (DDI) | 2130 | 2743 |
The AUCtau was defined as the area under the concentration curve divided by the dosing interval. AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1 for AUCtau; DDI cohorts: Day 1 of Cycle 1 AUC0-inf
| Intervention | hour*nanogram/milliliter (Median) |
|---|---|
| Non-DDI: AUCtau: Day 8 | |
| Pimasertib 45 mg+Temsirolimus 25 mg (Non-DDI) | 706 |
| Pimasertib 75 mg+Temsirolimus 25 mg (Non-DDI) | 1402 |
The AUCtau was defined as the area under the concentration curve divided by the dosing interval. AUC(0-inf) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1 for AUCtau; DDI cohorts: Day 1 of Cycle 1 AUC0-inf
| Intervention | hour*nanogram/milliliter (Median) | |
|---|---|---|
| DDI: AUCtau: Day 9 | DDI: AUC0-inf: Day 1 | |
| Pimasertib 45 mg+Temsirolimus 12.5 mg (DDI) | 628 | 573.2 |
| Pimasertib 45 mg+Temsirolimus 25 mg (DDI) | 805 | 828.6 |
Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: Drug-drug interaction (DDI) cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | nanogram/milliliter (Median) |
|---|---|
| Non-DDI: Day 8 | |
| Pimasertib 45 mg+Temsirolimus 25 mg (Non-DDI) | 197.6 |
| Pimasertib 75 mg+Temsirolimus 25 mg (Non-DDI) | 308.1 |
Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: Drug-drug interaction (DDI) cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | nanogram/milliliter (Median) | |
|---|---|---|
| DDI: Day 1 | DDI: Day 9 | |
| Pimasertib 45 mg+Temsirolimus 12.5 mg (DDI) | 185.2 | 131 |
| Pimasertib 45 mg+Temsirolimus 25 mg (DDI) | 193.5 | 192.1 |
Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 8
| Intervention | nanogram/milliliter (Median) |
|---|---|
| Non-DDI: Day 8 | |
| Pimasertib 45 mg+Temsirolimus 25 mg (Non-DDI) | 489.9 |
| Pimasertib 75 mg+Temsirolimus 25 mg (Non-DDI) | 480.9 |
Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 8
| Intervention | nanogram/milliliter (Median) | |
|---|---|---|
| DDI: Day 9 | DDI: Day 16 | |
| Pimasertib 45 mg+Temsirolimus 12.5 mg (DDI) | 457.5 | 281.1 |
| Pimasertib 45 mg+Temsirolimus 25 mg (DDI) | 505.3 | 511.8 |
Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | hour (Median) |
|---|---|
| Non-DDI: Day 8 | |
| Pimasertib 45 mg+Temsirolimus 25 mg (Non-DDI) | 1.5 |
| Pimasertib 75 mg+Temsirolimus 25 mg (Non-DDI) | 0.5833 |
Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 1 and 9 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | hour (Median) | |
|---|---|---|
| DDI: Day 1 | DDI: Day 9 | |
| Pimasertib 45 mg+Temsirolimus 12.5 mg (DDI) | 1 | 2.3 |
| Pimasertib 45 mg+Temsirolimus 25 mg (DDI) | 1.5 | 1.133 |
Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | hour (Median) |
|---|---|
| Non-DDI: Day 8 | |
| Pimasertib 45 mg+Temsirolimus 25 mg (Non-DDI) | 0.5 |
| Pimasertib 75 mg+Temsirolimus 25 mg (Non-DDI) | 0.55 |
Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | hour (Median) | |
|---|---|---|
| DDI: Day 9 | DDI: Day 16 | |
| Pimasertib 45 mg+Temsirolimus 12.5 mg (DDI) | 0.7417 | 0.9333 |
| Pimasertib 45 mg+Temsirolimus 25 mg (DDI) | 0.5667 | 0.5 |
The clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | liter/hour (Median) |
|---|---|
| Non-DDI: Day 8 | |
| Pimasertib 45 mg+Temsirolimus 25 mg (Non-DDI) | 6.284 |
| Pimasertib 75 mg+Temsirolimus 25 mg (Non-DDI) | 11.39 |
The clearance of a drug was a measure of the rate at which a drug was metabolized or eliminated by normal biological processes. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | liter/hour (Median) | |
|---|---|---|
| DDI: Day 9 | DDI: Day 16 | |
| Pimasertib 45 mg+Temsirolimus 12.5 mg (DDI) | 5.378 | 7.528 |
| Pimasertib 45 mg+Temsirolimus 25 mg (DDI) | 11.73 | 9.292 |
The Vz was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | liter (Median) |
|---|---|
| Non-DDI: Day 8 | |
| Pimasertib 45 mg+Temsirolimus 25 mg (Non-DDI) | 309.7 |
| Pimasertib 75 mg+Temsirolimus 25 mg (Non-DDI) | 172.9 |
The Vz was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Pharmacokinetic parameters were reported based on DDI and non-DDI cohorts as per plan. (NCT01378377)
Timeframe: DDI cohorts: Days 9 and 16 of Cycle 1; Non-DDI cohorts: Day 8 of Cycle 1
| Intervention | liter (Median) | |
|---|---|---|
| DDI: Day 9 | DDI: Day 16 | |
| Pimasertib 45 mg+Temsirolimus 12.5 mg (DDI) | 152 | 189.5 |
| Pimasertib 45 mg+Temsirolimus 25 mg (DDI) | 244.5 | 233 |
2 trials available for metformin and Mucositis
| Article | Year |
|---|---|
Phase 1 dose-finding study of metformin in combination with concurrent cisplatin and radiotherapy in patients with locally advanced head and neck squamous cell cancer.
Topics: Acute Kidney Injury; Aged; Anemia; Antineoplastic Combined Chemotherapy Protocols; Chemoradiotherapy | 2020 |
Incidence of mucositis in patients treated with temsirolimus-based regimens and correlation to treatment response.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanize | 2014 |
Incidence of mucositis in patients treated with temsirolimus-based regimens and correlation to treatment response.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanize | 2014 |
Incidence of mucositis in patients treated with temsirolimus-based regimens and correlation to treatment response.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanize | 2014 |
Incidence of mucositis in patients treated with temsirolimus-based regimens and correlation to treatment response.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanize | 2014 |
Incidence of mucositis in patients treated with temsirolimus-based regimens and correlation to treatment response.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanize | 2014 |
Incidence of mucositis in patients treated with temsirolimus-based regimens and correlation to treatment response.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanize | 2014 |
Incidence of mucositis in patients treated with temsirolimus-based regimens and correlation to treatment response.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanize | 2014 |
Incidence of mucositis in patients treated with temsirolimus-based regimens and correlation to treatment response.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanize | 2014 |
Incidence of mucositis in patients treated with temsirolimus-based regimens and correlation to treatment response.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanize | 2014 |