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Antineoplastic Agents

ON 01910

Protein Kinase Inhibitors

Enzyme Inhibitors

The starting dose is 650 mg/m2 per day for 3 continuous days every 2 weeks. In successive courses, infusion time may be increased by 1 day up to 7 days every two weeks and/or drug dose may be increased (650, 1050, 1700 mg/m2/day, etc.). After 4 2-week cycles, cycle length may be extended to 3 or 4 weeks. Treatment continues until evidence of disease progression, intolerable adverse events or withdraw of consent.

The drug is a sterile, concentrated 75mg/mL solution in polyethylene glycol 400, in labeled, sealed glass vials. The Concentrate must be diluted with aqueous infusion solutions (0.9% NaCl, USP and Water for Injection, USP according to instructions) immediately prior to intravenous administration.

ON 01910.Na

Lewis R. Silverman, MD

This is an open-label, Phase I study to determine the highest amount of the study drug, ON 01910.Na, that can be safety given to patients with high risk myelodysplastic syndromes (MDS) or refractory leukemias. Patients will receive ON 01910.Na (at a starting dose of 650 mg/m2) intravenously by 3-day continuous infusion once every 2 weeks. Successive courses will use longer infusion times and/or higher doses of the drug until toxicity, effectiveness, or ineffectiveness is recognized. In addition, the amount of drug in the blood will be measured, any antitumor activity will be documented, and the biological effect of ON 01910.Na on cell-cycle pathways will be evaluated in peripheral blood mononuclear cells.

Patients must have histologically documented or cytologically confirmed diagnosis of acute myelocytic leukemia refractory to standard induction treatment, or relapsed after standard therapy; acute lymphocytic leukemia refractory to induction treatment, or relapsed after effective therapy; chronic myelocytic leukemia refractory to imatinib therapy or second line tyrosine kinase inhibition, or relapsed after tyrosine kinase inhibition, in chronic, accelerated, or blastic phase; chronic lymphocytic leukemia refractory to standard therapy, or relapsed in second relapse; a myelodysplastic syndrome (including chronic myelomonocytic leukemia) refractory to azacitidine; and an int-2 or high myelodysplastic syndrome relapsed after a hypomethylating agent. Patients may not be eligible for, or must have declined, bone marrow transplantation or other chemotherapeutic regimens known to produce consistent remissions. Because hematopoietic criteria in leukemia and lymphoma are confounded by the nature of the diseases themselves, there are no hematologic exclusions from treatment. If leukopenia is clinically determined to be attributable to prior treatment, ON 01910.Na treatment may start when the leukocyte count increases on two successive determinations performed at least three days apart. Thrombocytopenia is not a criterion, and patients will be supported with platelet transfusions as clinically necessary. In the absence of leukopenia, a failed prior treatment may be succeeded immediately by entry into study of ON 01910.Na if the leukocyte count is stable or rising, on two successive determinations performed at least three days apart, in the absence of other drug toxicity.

The patient population will involve approximately 12 to 28 patients ≥ 18 years of age in the dose escalation portion of the protocol. All patients must have relapsed or refractory leukemia or poor risk MDS (i.e., int-2 or high risk MDS who have failed standard therapy). They must not be candidates for known regimens or protocol treatments of higher efficacy or priority. Patients with relapsed/refractory leukemia or poor risk MDS must have an ECOG Performance Status of 0, 1, or 2. Patients must have an expected survival, in the opinion of the Investigator, to allow a sufficient observation period for evaluating ON 01910.Na, and meet the eligibility criteria for patients with leukemia or poor risk MDS. After the maximally tolerated dose and the Recommended Phase II Dose (RPTD) and duration are determined, up to 12 additional patients with histologically documented or cytologically confirmed leukemia or poor risk MDS will be added to confirm the appropriateness of the RPTD. Inclusion criteria for the dose confirmation phase will be similar to those of the dose escalation phase of the study, but the ECOG Performance Status must be 0 or 1.

Safety data, including laboratory parameters and adverse events, will be collected for all patients in order to determine the qualitative and quantitative toxicity, and reversibility of toxicity, of ON 01910.Na. Leukemic cells and MDS cells in peripheral blood will be measured on a daily basis during infusion, and at least two times weekly during the following week. If leukemic cells disappear from the blood or blood counts improve as defined by IWG criteria in MDS patients, a bone marrow aspiration will be performed to determine response status in the bone marrow.

All patients may continue therapy for at least six cycles unless rapid disease progression is documented. Patients with an objective clinical response or stable disease can continue up to six more cycles. Further continuation will be determined by the clinical judgment of the Investigator.

Phase I Study of ON 01910.Na in Refractory Leukemia or Myelodysplastic Syndrome (MDS)

Phase I Dose Escalation Study of ON 01910.Na With Increasing Duration of an Initial 3-Day Continuous Infusion in Patients With Refractory Leukemia or MDS

Traws Pharma, Inc.

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Treatment with MBG453 single agent Q4W to confirm safety and tolerability of RD.

Treatment with NIS793 single agent Q3W to establish RD in this indication and confirm safety and tolerability.

Treatment with single agent canakinumab Q4W to confirm safety and tolerability of RD.

Treatment with combination of MBG453 and NIS793 Q3W to confirm safety and tolerability of combination RD.

Treatment with MBG453 + canakinumab combination Q4W to confirm safety and tolerability of combination RD.

MBG453

NIS793

canakinumab

The purpose of this study was to characterize the safety, tolerability and confirm the dose for select single agents and combinations in patients with lower risk (very low, low, and intermediate risk) MDS.

This was a phase Ib, multi center, open-label, platform study with multiple treatment arms.

The design of this study was adaptive to allow discontinuation of poorly tolerated or ineffective treatments and to facilitate the introduction of new candidate single agents or combinations. Study design included a dose escalation/confirmation part and a dose expansion.

The planned initial single agent and combination treatment arms were the following:

* Arm 1: MBG453 single agent
* Arm 2: NIS793 single agent
* Arm 3: canakinumab single agent
* Arm 4: MBG453 + NIS793 combination
* Arm 5: MBG453 + canakinumab combination Patients were treated in the dose confirmation/escalation part of the study in Arms 1, 2, 3 and 5. No patients were treated in Arm 4. The study did not progress into the expansion phase.

Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS

A Phase Ib, Multicenter, Open-label Platform Study of Select Drug Combinations in Adult Patients With Lower Risk (Very Low, Low, or Intermediate Risk) Myelodysplastic Syndrome

Incidence of dose limiting toxicities (DLTs) during the first 2 cycle of treatment during the dose escalation/confirmation part

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as per CTCAE v5.0, by treatment

The number of red cell or platelet transfusions a patient receives over the course of study treatment will be compared to the patient's baseline transfusion requirements based on the number of transfusions received during the 16-weeks period prior to the start of study treatment.

Red cell or platelet transfusion independence is defined as no red cell or platelet transfusions with a duration lasting for 8, 12, 16, or 24 weeks.

Hemoglobin levels over the course of the study will be compared to the patient's baseline level to monitor for improvements in anemia.

Platelet count over the course of the study will be compared to the patient's baseline count to monitor for improvements in thrombocytopenia.

BOR is the best disease response recorded from the start of the treatment until disease progression/relapse. The subject's BOR will be calculated based on investigator's response evaluations per International Working Group (IWG) criteria.

Time to onset of either red cell transfusion independence or platelet transfusion independence.

Time to onset of BOR is defined as the time between date of start of study treatment to the date of first onset of Partial Response (PR) or better response.

DOR is defined as the duration from the first documented onset of complete response (CR), complete remission with partial hematologic recovery (CRh), bone marrow CR (mCR) or PR to the date of disease progression (PD) or relapse or death due to myelodysplastic syndrome (MDS).

ORR is the proportion of subjects with a best overall response of either CR or CRh, or mCR or PR.

PFS is defined as the time from the start of treatment until death due to any reason, disease progression, or relapse, whichever comes first.

TTP is the time from the start of treatment to the date of PD, relapse or death due to underlying cancer.

Serum concentrations and derived PK parameters

Anti-drug antibody prevalence at baseline and on treatment.

Novartis Pharmaceuticals

5-day continuous intravenous dosing of ON 01910.Na given every 2 weeks (1 cycle) at a dose of 800 mg/m2/day or 1500mg/m2/day for up to 24 cycles.

ON 01910.Na Concentrate

Virginia Klimek, MD

For MDS patients who have not responded to or have progressed after an initial response to DNA methyltransferase inhibitors (DNMTI) and are not stem cell transplant candidates, therapeutic options are limited. Participation in clinical trials such as this one may be considered. The specific objectives of this trial are to find out which dose of ON 01910.Na can be safety given to MDS patients and then find out if this dose of drug has any beneficial effects on the patients' disease. ON 01910.Na is a new, experimental drug; the reason for doing this trial is based on the anti-cancer activity of ON 01910.Na that has been observed in laboratory experiments and in early clinical trials.

This is a single center, open label, phase 1/2 study in which two to thirty three patients with Intermediate-1, Intermediate-2, or High risk MDS will receive ON 01910.Na as a intravenous continuous infusion (IVCI) over 24 hours for 5 consecutive days every 2 weeks.

In the phase 1 component of this trial the maximum tolerated dose of ON1910.Na in patients with Intermediate-1, Intermediate-2 or High Risk myelodysplastic syndromes will be determined. A standard "3+3" dose escalation scheme will be followed with up to six patients treated at the 800 mg/m2/day dose level. Patients will be observed for 2 cycles before dose escalation occurs. If none of the initial three patients in the 800 mg/m2/day cohort experience dose-limiting toxicity (DLT), during the first two cycles, then a new cohort of three patients will be treated at the 1500 mg/m2/day dose level. If none of the initial three patients in the 1500 mg/m2/day cohort experience DLT during the first two cycles, three additional patients will be treated at the 1500 mg/m2/day level. If no more than one of the six patients at the 1500 mg/m2/day dose level experiences a DLT, then that dose level will be confirmed as the MTD and no further dose escalation will occur.

If one of the three patients in the 800 mg/m2/day cohort experiences DLT during the first two cycles, then up to three additional patients will be treated at the same dose level. Escalation to 1500 mg/m2/day will proceed if only one of the six patients experiences DLT at the 800 mg/m2/day dose level. If two or more patients in the 800 mg/m2/day cohort experience DLT during the first two cycles, then the maximum tolerated dose (MTD) will have been exceeded, no further dose escalation will occur, and a full safety review will determine if further enrollment of patients will proceed.

If the 800 mg/m2/day dose level is under consideration as the MTD (i.e. if ≥ 2 patients experience DLT at the 1500 mg/m2/day dose level), and only three patients were treated before escalation to 1500 mg/m2/day, then three additional patients will be accrued. If no more than one of the six patients at the 800 mg/m2/day dose level experiences a DLT, then that dose level will be confirmed as the MTD.

Once the phase 1 portion of the study is completed, accrual to the phase 2 portion will begin. Patients treated at the MTD during the phase 1 portion will be included in the phase 2 component and will be evaluated for response and secondary end points.

The total study duration is 29 weeks, which includes a 2-week screening phase, a 23-week dosing phase, and a 4-week follow-up phase that begins after the last dose of ON 01910.Na. Patients will be assessed for response and will undergo follow up.

Patients who drop out for any reason will not be replaced. Patients who achieve a complete or partial response or stabilization of their disease by week 25 are eligible to receive an additional 24 weeks of ON 01910.Na at the same dose they received during the first 24 weeks of treatment(800 or 1500 mg/m2/day IVCI for 5 days Q2W).

Efficacy and Safety of 5-day Dosing of ON 01910.Na in Intermediate-1,-2, or High Risk Myelodysplastic Syndrome (MDS)

A Phase 1/2, Single-Arm Study To Assess The Efficacy and Safety Of 5-day Continuous Intravenous Dosing Of ON 01910.Na Administered Every 2 Weeks in Patients With Intermediate-1, Intermediate-2, or High Risk Myelodysplastic Syndrome (MDS)

Infections

Communicable Diseases

Diet A would include fresh fruits and/or fresh vegetables in a liberalized hospital diet, and subjects will be encouraged to eat at least one daily serving of fresh fruits and/or vegetables.

Diet Intervention: Subjects will undergo stratified randomization to account for the heterogeneous population, to receive one of the two diets: liberalized hospital diet (Diet A) or a neutropenic diet (Diet B).

Diet

Zeina A Al-Mansour, MD

This is an open-label, two-arm, phase III non-inferiority trial to evaluate the safety of a liberalized hospital diet inclusive of fresh fruits and vegetables to a neutropenic diet in patients with prolonged neutropenia. Both cohorts and diets will adhere to the hygiene and common sense advice listed in the FDA-endorsed food safety guidelines.

Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)

A Phase III, Randomized, Clinical Trial Comparing Two Diets in Patients Undergoing Hematopoietic Stem Cell Transplant (HSCT) or Remission Induction Chemotherapy for Acute Leukemia and Myelodysplastic Syndrome (UF-BMT-LDND-101)

The primary objective of the trial is to compare the incidence of major infections in subjects undergoing HSCT or receiving induction chemotherapy for acute leukemia with prolonged neutropenia (less than or equal to 7 days) who are receiving either Diet A or Diet B.

This secondary objective of the trial is to compare the impact of diet on severe infections including: septic shock, bloodstream infection, invasive fungal infection, upper respiratory infection, infectious \& non-infectious pneumonia, C. difficile infection, Vancomycin-resistant \& -sensitive enterococcal colonization, Vancomycin-resistant \& -sensitive enterococcal infections, febrile neutropenia, typhlitis, lower tract respiratory viral infections, infection-related mortality, and admission to the ICU.

This secondary objective of the trial will examine the admission frequency to the intensive care unit (ICU).

This secondary objective of the trial will evaluate the degree of compliance to each diet from the time of initiation of the diet intervention until either the Absolute Neutrophil Count (ANC) is equal to or less than 500/mm3, the subject is discharged from the hospital, the subject is transferred from the unit, or after 30 days of ANC less than 500/mm3.

This secondary objective of the trial will evaluate the impact of each diet on nutritional status as assessed by PG-SGA.

This secondary objective of the trial will evaluate the impact of mucositis on dietary intake.

This secondary objective of the trial is to compare symptoms between diets using the MDASI tool.

This secondary objective of the trial is to compare the QoL between diets as assessed by FACT-G.

This secondary objective of the trial is to evaluate OS from 1 year following randomization

This secondary objective of the trial is to evaluate PFS from 1 year following randomization

This secondary objective of the trial is to evaluate the incidence of GVHD in allogeneic HSCT subjects only.

University of Florida

Anti-Infective Agents

Amino Acids

Etoposide

Cytarabine

Daunorubicin

Plerixafor

Etoposide phosphate

Tyrosine Kinase Inhibitors

Clofarabine

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Tyrosine

Fixed dose of Plerixafor (240mcg/kg) given by subcutaneous injection on each day of chemotherapy for up to 3 courses (depending on cohort). The three chemotherapy courses will be Daunorubicin/Clofarabine for courses 1\&2 and Daunorubicin/Ara-C for course 3. Each course will last 5 days, and Plerixafor will be given for 5 days.

Each cohort of patients will receive three courses of chemotherapy approximately 4 to 5 weeks apart which will comprise of Daunorubicin/Ara-C/Etoposide in Courses 1\&2 and Daunorubicin/Ara-C in Course 3. Two days after the last day of each chemotherapy course, patients will receive AC220 orally for 7, 14 or 21 (depending on cohort) consecutive days. Depending on which cohort the patient enters, they will receive either 60mg, 90mg or 135mg of AC220 daily, with a provision to assess 40mg if necessary.

AC220

Patients will receive 3 treatments of ganetespib on days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which will be associated with 3 administrations of ganetespib.

Ganetespib

Alan K Burnett

Nigel H Russell

The AML18 Pilot Trial will evaluate the feasibility of three interventions that are planned to be included in the forthcoming NCRI AML18 Trial. One intervention will be to evaluate combining the Tyrosine Kinase Inhibitor AC220 with three courses of standard DAE (Daunorubicin, Ara-C, Etoposide). AC220 will be given following each treatment course, daily by mouth for 7, 14 or 21 days. AC220 will be evaluated at 3 dose levels of 60, 90 and 135 mg flat dose. A 4th dose level of 40 mg will be introduced should patients not respond well to 60 mg. The second intervention to be tested is the combination of the CXCR4 inhibitor Plerixafor with up to three courses of the chemotherapy combination of DClo (Daunorubicin, Clofarabine). Patients/investigators will be able to choose which intervention to enter. Depending on recruitment requirements, only one intervention might be available at any one time. The third intervention Patients will receive 3 treatments of 100 mg of ganetespib on days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which will be associated with 3 administrations of ganetespib.

The AML18 Pilot Trial is available to any patient who has primary or secondary AML as defined by the WHO Classification (Appendix A) (excluding Acute Promyelocytic Leukaemia), or high risk Myelodysplastic Syndrome (i.e. \> 10% marrow blasts) who is not considered suitable for the current NCRI trial for younger patients (MRC AML 17). This trial has the primary aim of assessing the feasibility of three treatments that are planned for the forthcoming NCRI AML18 Trial. The first is the feasibility of adding AC220, given sequentially initially for 7 days, to three courses of standard chemotherapy. AC220 will be assessed at up to three daily dose levels: - 60mg/day, 90mg/day, 135 mg/day and also, if required, at 40mg/day. The protocol will also assess in a separate study cohort the feasibility of combining the CXCR4 inhibitor, Plerixafor, at a fixed dose in combination with up to three courses of chemotherapy. The third intervention patients will receive 3 treatments of ganetespib on days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which will be associated with 3 administrations of ganetespib.

THERAPEUTIC INTERVENTIONS

Therapeutic Interventions for AC220 Assessment:

Patients will enter one of 3 dose level cohorts either 60mg/day, 90mg/day or 135mg/day with the provision to assess 40mg/day if required. Each cohort will receive three courses of chemotherapy approximately 4 to 5 weeks apart, which will comprise DAE ( Daunorubicin, Ara-C, Etoposide) over 10 days (Course 1) , DAE over 8 days (Course 2) and DA (Daunorubicin, Ara-C) over 5 days (Course 3). Two days after the last day of chemotherapy patients will receive the AC220 orally, daily for 7 consecutive days. Formal safety and pharmaco-kinetic assessments will be undertaken on day 1, 7 and 14 of each course of AC220, and interim toxicities will also be required to be reported. Sufficient patients must enter each AC220 dose level cohort to ensure that at least 3 patients are evaluable for all three courses. Cohort 2 (i.e.60mg/day for 14 days) can open to recruitment after a minimum of 3 evaluable patients have completed course 1. Cohort 3 (40mg/day dose level for either 7/14 days) will be undertaken if cohort 1 or 2 are unsuccessful i.e. fail to satisfy the safety criteria.

It is anticipated that the 'study dose' will be established from the experience of cohorts 1 to 5. Cohort 6 ('study dose') will receive AC220 for 21 days after each chemotherapy course. In this cohort there must be a minimum of a 10 days break between the end of the AC220 course and the start of the subsequent chemotherapy course.

Therapeutic Interventions for Plerixafor Assessment:

The aim is to assess the feasibility of combining a fixed dose (240mcg/kg) of Plerixafor given on each day of chemotherapy for up to 3 courses, and if so to combine this with G-CSF in courses 2 and 3. The three chemotherapy courses will be Daunorubicin/Clofarabine (DClo) for courses 1 \& 2 and Daunorubicin/Ara-C (DA) for course 3. Each course will last 5 days and Plerixafor will be given for 5 days.

Cohort 1 will receive three courses of chemotherapy with Plerixafor in course 1 only. Cohort 2 will receive three courses with Plerixafor in course 1 and 2. Cohort 3 will receive chemotherapy with Plerixafor in all three courses. Cohort 4 will be the same as cohort 3 but they will also receive G-CSF in course 2 and 3.

Therapeutic Interventions for Ganetespib Assessment:

There will be one feasibility cohort of 10 evaluable patients who require to be evaluable after 30 days after the first course, where day 1 is the first day of chemotherapy. Patients will receive 3 treatments of ganetespib on days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which will be associated with 3 administrations of ganetespib.

A Trial to Establish the Feasibility of Combining Either the Tyrosine Kinase Inhibitor AC220,CXCR4 Inhibitor Plerixafor or HSP90 Inhibitor Ganetespib With Chemotherapy in Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.

An NCRI Acute Myeloid Leukaemia Working Group Pilot Trial Under the Auspices of the Cardiff Experimental Cancer Medicine Centre to Establish the Feasibility of Combining Either the Tyrosine Kinase Inhibitor AC220,CXCR4 Inhibitor Plerixafor or HSP90 Inhibitor Ganetespib With Chemotherapy in Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I Study of ON 01910.Na in Refractory Leukemia or Myelodysplastic Syndrome (MDS)	NCT00854646	Acute Myelocyti... Acute Lymphocyt... Chronic Myelocy... Chronic Lymphoc... Myelodysplastic...	ON 01910.Na	18 Years -	Traws Pharma, Inc.
Phase I Study of ON 01910.Na in Refractory Leukemia or Myelodysplastic Syndrome (MDS)	NCT00854646	Acute Myelocyti... Acute Lymphocyt... Chronic Myelocy... Chronic Lymphoc... Myelodysplastic...	ON 01910.Na	18 Years -	Traws Pharma, Inc.
Phase Ib Study of Select Drug Combinations in Patients With Lower Risk MDS	NCT04810611	Myelodysplastic...	MBG453 NIS793 canakinumab	18 Years -	Novartis
Efficacy and Safety of 5-day Dosing of ON 01910.Na in Intermediate-1,-2, or High Risk Myelodysplastic Syndrome (MDS)	NCT00867061	Myelodysplastic...	ON 01910.Na Con...	18 Years -	Traws Pharma, Inc.
Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)	NCT03016130	Leukemia Myelodysplastic...	Diet	18 Years -	University of Florida
Phase I Study of ON 01910.Na in Refractory Leukemia or Myelodysplastic Syndrome (MDS)	NCT00854646	Acute Myelocyti... Acute Lymphocyt... Chronic Myelocy... Chronic Lymphoc... Myelodysplastic...	ON 01910.Na	18 Years -	Traws Pharma, Inc.
A Trial to Establish the Feasibility of Combining Either the Tyrosine Kinase Inhibitor AC220,CXCR4 Inhibitor Plerixafor or HSP90 Inhibitor Ganetespib With Chemotherapy in Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.	NCT01236144	Acute Myeloid L... High Risk Myelo...	Plerixafor AC220 Ganetespib	60 Years -	Cardiff University
A Trial to Establish the Feasibility of Combining Either the Tyrosine Kinase Inhibitor AC220,CXCR4 Inhibitor Plerixafor or HSP90 Inhibitor Ganetespib With Chemotherapy in Older Patients With Acute Myeloid Leukaemia and High Risk Myelodysplastic Syndrome.	NCT01236144	Acute Myeloid L... High Risk Myelo...	Plerixafor AC220 Ganetespib	60 Years -	Cardiff University
Comparing Two Diets in Patients Undergoing HSCT or Remission Induction Chemo for Acute Leukemia and MDS (UF-BMT-LDND-101)	NCT03016130	Leukemia Myelodysplastic...	Diet	18 Years -	University of Florida

Spots Global Cancer Trial Database for myelodysplastic