Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Dose escalation group starting dose: Erlotinib 75 mg by mouth daily for a 28 day cycle. Starting dose of Pralatrexate 15 mg/m2 by vein on days 1, 8, and 15 of a 28 day cycle.

Dose expansion group starting dose: Maximum tolerated dose (MTD) from dose escalation group.

Dose escalation group starting dose: 75 mg by mouth daily for a 28 day cycle.

Dose expansion group starting dose: Maximum tolerated dose (MTD) from dose escalation group.

Erlotinib

Dose escalation group starting dose: 15 mg/m2 by vein on days 1, 8, and 15 of a 28 day cycle.

Dose expansion group starting dose: Maximum tolerated dose (MTD) from dose escalation group.

Pralatrexate

Shumei Kato, MD

The goal of this clinical research study is to find the highest tolerable dose of the combination of erlotinib and pralatrexate that can be given to patients with advanced cancer. The safety of the drug combination will also be studied.

Pralatrexate is designed to block the body's ability to make folic acid, a protein that may help cancer tissue to develop and spread.

Erlotinib hydrochloride is designed to block proteins that are thought to cause cancer cells to grow. Erlotinib may help slow the growth of tumors.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of erlotinib and pralatrexate based on when you join this study.

Dose Escalation:

Several dose levels of erlotinib and pralatrexate will be tested. Three (3) to 6 participants will start at the lowest planned doses of erlotinib and pralatrexate. Each new group of 3-6 participants will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of erlotinib in combination with pralatrexate is found.

Dose Expansion:

Once the highest tolerable dose or most appropriate combination dose level is found, 10 more participants will take the study drugs at this dose level.

Study Drug Administration:

Each study cycle is 28 days.

Up to 10 days before you start treatment , you will start taking folic acid to help lower the risk of side effects. Although the study drug is designed to prevent the body from making folic acid that could help cancer grow and spread, some folic acid is needed to prevent side effects in non-cancerous tissue. You will take folic acid by mouth 1 time every day during treatment and for at least 30 days after you received the last dose of pralatrexate.

Up to 10 days before you start treatment, you will receive a vitamin B12 injection. You will receive an injection of Vitamin B12 about every 3 months after that.

On Days 1, 8, and 15 of each cycle, you will receive pralatrexate by vein over 3-5 minutes.

You will take erlotinib hydrochloride by mouth 1 time a day every day. You should take erlotinib hydrochloride on an empty stomach either 1 hour before eating or 2 hours after eating.

You will take erlotinib at home except on the days when you have a study visit. You should take it at about the same time each day with about a cup (8 ounces) of water.

Study Visits:

At every study visit, you will be asked about any current health conditions you have, any other drugs you are taking, and if you have had any side effects.

If the screening tests were performed within 7 days before Cycle 1, tests and procedures may not have to be repeated.

At any time during Cycle 1:

* You will have a physical exam, including measurement of your weight at least 1 time per cycle.
* Your vital signs will be measured.
* Your performance status will be recorded.
* Blood (about 2 teaspoons) will be drawn for routine tests and to see how well your blood clots.
* If you are taking part in the expansion phase, blood (about 2 teaspoons) will be drawn for pharmacodynamic (PD) testing.

At any time during Cycle 2:

* You will have a physical exam, including measurement of your weight at least 1 time per cycle.
* Your vital signs will be measured.
* Your performance status will be recorded.
* Blood (about 4 teaspoons) will be drawn for routine tests.
* If you are taking part in the expansion phase, blood (about 2 teaspoons) will be drawn for PD testing.

About every 8 weeks, you will have an x-ray, CT scan, MRI scan, and/or positron emission computed tomography (PET)/CT scan to check the status of the disease. Blood (about 1 teaspoon) may be drawn for tumor marker testing depending on the type of tumor. If the study doctor thinks it is needed, they will be performed more or less often.

At any time during Cycle 3 and beyond:

* You will have a physical exam, including measurement of your weight at least 1 time per cycle.
* Your vital signs will be measured.
* Your performance status will be recorded.
* Blood (about 2 teaspoons) will be drawn for routine tests.

Length of Dosing:

You may continue taking the study drugs for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over once you have completed the end-of-treatment and follow-up visits.

End of Dosing Visit:

After you are finished taking the study drugs:

* You will have a physical exam, including measurement of your weight and vital signs.
* Your performance status will be recorded.
* Blood (about 2 teaspoons) and urine will be collected for routine tests.

This is an investigational study. Pralatrexate is FDA approved and commercially available for the treatment of cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). Erlotinib is FDA approved and commercially available for the treatment of pancreatic cancer and non small cell lung cancer (NSCLC). The study drug combination is investigational.

Up to 74 patients will take part in this study. All will be enrolled at MD Anderson.

Erlotinib in Combination With Pralatrexate in Advanced Malignancies

A Phase I Dose-Escalation Study of Erlotinib in Combination With Pralatrexate in Subjects With Advanced Cancer

MTD defined by dose limiting toxicities (DLTs) that occur in the first cycle. DLT defined as any Grade 3 or 4 non-hematologic toxicity as defined in the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. Grade 4 hematologic toxicity lasting 2 weeks or longer despite supportive care. Grade 4 nausea or vomiting \> 5 days despite maximum anti-nausea regimens, and any other Grade 3 non-hematologic toxicity, including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in NCI-CTCAE as attributable to therapy.

Tumor response defined as one or more of the following: (1) stable disease for more than or equal to 4 months, (2) decrease in measurable tumor (sentinel lesions) by more than or equal to 20% by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, (3) decrease in tumor markers by more than or equal to 25% (for example, a \>/= 25% decrease in CA125 for patients with ovarian cancer), or (4) a partial response according to the Choi criteria, i.e. decrease in size by 10% or more, or a decrease in tumor density, as measured in Hounsfield units (HU), by more than or equal to 15% (28).

M.D. Anderson Cancer Center

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Antirheumatic Agents

Anti-Inflammatory Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Vincristine

Dose finding Phase Intervention: Folotyn (Pralatrexate Injection) CHOP: Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone

The first cohort will begin with three patients with dose A of pralatrexate plus CHOP at full dose.

The second cohort will begin with three patients with dose B of pralatrexate plus CHOP at full dose.

The third cohort will begin with three patients with dose C of pralatrexate plus CHOP at full dose.

The fourth cohort will begin with three patients with dose D of pralatrexate plus CHOP at full dose.

The fifth cohort will begin with three patients with dose E of pralatrexate plus CHOP at full dose.

Part 2: Dose Expansion, Additional ten patients will be enrolled at the MTD or MAD (if the MTD is not reached) plus CHOP at full dose in this part of the study. Blood samples for PK analysis of pralatrexate will be collected at various intervals pre and post pralatrexate injection during cycle 1, Dose 1.

Drug: Folotyn (Pralatrexate Injection)

CHOP : Cyclophosphamide, Doxorubicin, Vincristine, \& Prednisone

Pralatrexate Injection

Erard Gilles, MD

The purpose of this study is to evaluate the Maximum Tolerated Dose (MTD) of pralatrexate in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in patients with newly diagnosed peripheral T-cell lymphoma (PTCL).

This is a Phase 1, open-label, multicenter, two-part, dose-finding, dose-escalation study.

The study is divided into two parts:

Part 1

Up to five sequential dose cohorts will enroll a maximum of 6 patients each. Escalation of the pralatrexate dose, after CHOP administration (Fol-CHOP), will continue in a traditional 3+3 design, until determination of the MTD. If the MTD is not reached, the Maximum Administered Dose (MAD) of pralatrexate in combination with CHOP will be 30 mg/m2 IV on Days 1 and 8 of each 21-day cycle for up to 6 cycles.

The first cohort will begin with three patients with dose A and CHOP at full dose. If none of the first three patients experiences a Dose-Limiting Toxicity (DLT), the next three patients will be enrolled in next higher dose cohort. If one of the first three patients in the first cohort experiences DLTs, an additional three patients will be enrolled into that cohort. If 2 or 3 of the first 3 patients experience DLTs, then the MTD is not found.

For cohorts 2, 3, 4, and 5, If none of the first three patients experiences a DLT, the next three patients will be enrolled in next higher dose cohort. If one of the first three patients in the first cohort experiences DLTs, an additional three patients will be enrolled into that cohort. If 2 or 3 of the first 3 patients experience DLTs, then the previous cohort will be considered the MTD and up to an additional 10 patients will be enrolled at that dose in Part 2 of the study.

Part 2

Once the MTD for the Fol-CHOP regimen has been established in Part 1 of the study, an additional 10 patients will be treated at the MTD (or MAD if MTD not reached) to confirm tolerability. Additionally, the PK of the established MTD of pralatrexate, when administered with CHOP at full dose, will be evaluated in these 10 patients.

A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL)

A Phase 1, Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With Peripheral T-Cell Lymphoma (PTCL)

To evaluate the Maximum Tolerated Dose (MTD) of pralatrexate in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in patients with newly diagnosed peripheral T-cell lymphoma (PTCL)

Investigator will question the patient at every visit about AEs and intercurrent illnesses.

To evaluate the Objective Response Rate (ORR) of 6 cycles of Fol-CHOP

Measure the concentration of pralatrexate to evaluate the pharmacokinetics of pralatrexate when given in combination with CHOP using non-compartmental analysis.

Axis Clinicals Limited

Acrotech Biopharma Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Mouth and Tooth Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Mucositis

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Micronutrients

Vitamins

Leucovorin

Levoleucovorin

Antidotes

Protective Agents

Folinic Acid

5 mg/m2 QID (6 hours apart) starting on Days 2 and 16 (24 hours after Folotyn dose) for a total of 20 doses in a 28-day cycle

Days 2 and 16: 4 doses/day

Days 3 and 17: 4 doses/day

Days 4 and 18: 2 doses/day

Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle

5 mg/m2 BID 8 hours apart on Days 2, 3, 4, 16, 17, and 18 for a total of 12 doses in a 28-day cycle.

Fusilev dose to start 24 hours after Folotyn dose.

Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle

5 mg/m2 BID 8 hours apart on Days 2, 3, 16, and 17 for a total of 8 doses in a 28-day cycle.

Fusilev dose to start 24 hours after Folotyn dose.

Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle

5 mg/m2 BID 8 hours apart on Days 2 and 16 for a total of 4 doses in a 28-day cycle.

Fusilev dose to start 24 hours after Folotyn dose.

Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle

5 mg/m2 once on Days 2 and 16 for a total of 2 doses in a 28-day cycle

Folotyn: 190 mg/m2 on Days 1 and 15 in a 28-day cycle

A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.

Folotyn

Fusilev will be administered either four times a day (QID) (6 hours apart, ±10 minutes), twice a day (BID) (8 hours apart, ±10 minutes) or once a day (QD) by IV push (3-5 minutes) at a dose of 5 mg/m2 according to the cohort to which patients are assigned.

Fusilev

To determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis in patients with Non-Small Cell Lung Cancer.

This is an open-label, uncontrolled, nonrandomized, multicenter, dose-finding, single-arm, Phase 1 study primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral mucositis.

Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®

An Open Label, Multicenter, Dose Finding, Single Arm, Phase 1 Study of Fusilev® (Levoleucovorin) to Prevent or Reduce Mucositis in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer Receiving Folotyn® (Pralatrexate)

The study period will begin on the first day of Folotyn treatment (Day 1). Folotyn will be administered intravenously (IV) at a dose of 190 mg/m2 on Days 1 and 15 in a 28-day treatment cycle. Twenty-four hours after the Folotyn dose, Fusilev will be administered either four times a day (QID) (6 hours apart, ±10 minutes), twice a day (BID) (8 hours apart, ±10 minutes) or once a day (QD) by IV push (3-5 minutes) at a dose of 5 mg/m2 according to the cohort to which patients are assigned. Within a given cohort, Fusilev will be administered at the same dose and schedule after each Folotyn dose for the duration of the study.

Analysis will involve the number, percent and type of Folotyn dose modification as a function of Fusilev dose.

Distribution of the number of cases of oral mucositis will be described by cohort and by degree of mucositis.

Oral mucositis assessment form will be provided by the sponsor and is to be completed during treatment visits on day 1 \& 15, days 4 \&18, end of treatment visits. Patients will complete an Oral Mucositis Daily Questionnaire (OMDQ) starting at Day 1 of Cycle 1 and ending at the End of Treatment visit. Oral mucositis assessment will be assessed in the clinic by the investigator, or designee, and graded according to AE severity as established in the NCI CTCAE scale, Version 4.0.

All treatment-emergent AEs will be managed per the investigator's judgment or the site's clinical standard of care. Folotyn decrease dose modifications will be made based on Hematologic Adverse Events (absolute neutrophil count) and Non- Hematologic Adverse events (CTCAE v.4) excluding nausea/vomiting for dose adjustments

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Erlotinib in Combination With Pralatrexate in Advanced Malignancies	NCT01532011	Advanced Cancer... Solid Tumors	Erlotinib Pralatrexate	12 Years -	M.D. Anderson Cancer Center
A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL)	NCT02594267	Peripheral T-Ce...	Pralatrexate In...	18 Years -	Acrotech Biopharma Inc.
Erlotinib in Combination With Pralatrexate in Advanced Malignancies	NCT01532011	Advanced Cancer... Solid Tumors	Erlotinib Pralatrexate	12 Years -	M.D. Anderson Cancer Center
A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL)	NCT02594267	Peripheral T-Ce...	Pralatrexate In...	18 Years -	Acrotech Biopharma Inc.
Phase 1 Study of Fusilev® to Prevent or Reduce Mucositis in Patients With Non-Small Cell Lung Cancer Receiving Folotyn®	NCT01820091	Non-Small Cell ...	Folotyn Fusilev	18 Years -	Acrotech Biopharma Inc.
A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL)	NCT02594267	Peripheral T-Ce...	Pralatrexate In...	18 Years -	Acrotech Biopharma Inc.

Spots Global Cancer Trial Database for folotyn

Every month we try and update this database with for folotyn cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for folotyn

Every month we try and update this database with for folotyn cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for folotyn cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.