A Study of the Safety and Pharmacokinetics of RO6839921, An MDM2 Antagonist, in Patients With Advanced Cancers, Including Acute Myeloid Leukemia.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-21

Study Completion Date

2018-05-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This open label, Phase I study of RO6839921 is a dose-escalation study with two arms. Prior to investigations in either arm, patients in a single cohort, Cohort 0, will receive non-escalating, intravenous (IV) doses of RO6839921 daily on Days 1-5 of a 28-day cycle. Interim PK and safety data from this cohort will be evaluated before initiating dose-escalation.

In arm A, RO6839921 will be given to patients with advanced solid tumor malignancies. In Arm B, RO6839921 will be given to patients with relapsed/refractory acute myeloid leukemia (AML). The arms will escalate independently. Escalation will begin in solid tumor patients (Arm A) in single patient cohorts, using a new Continual Reassessment Method (n-CRM). Escalation for AML patients will be initiated at or below the dose level that causes \>/= Grade 2 hematologic side effects in Arm A. Escalation in AML patients will follow a rolling 6 design.

In both arms, RO6839921 will be administered by IV infusion on Days 1-5 of 28-day cycles.

There will be no intrapatient dose escalation. All patients may be treated until disease progression/relapse or unacceptable toxicity.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7283420.

NCT04580121

Acute Myeloid Leukemia

COMPLETED PHASE1

An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies

NCT01677780

Myelogenous Leukemia, Chronic, Neoplasms, Myelogenous Leukemia, Acute

COMPLETED PHASE1

Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene

NCT05886049

Acute Myeloid Leukemia With KMT2A Rearrangement Acute Myeloid Leukemia With NPM1 Mutation

RECRUITING PHASE1

A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

NCT06226571

Acute Myeloid Leukemias

RECRUITING PHASE1

A Phase I Study of BC3402 as a Single Agent in Patients With MDS and CMML

NCT05690425

Hematologic Malignancy

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms, Myelogenous Leukemia, Acute

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acute myeloid leukemia patients

Group Type EXPERIMENTAL

RO6839921

Intervention Type DRUG

Escalating IV doses of RO6839921 in AML patients. Escalation will follow an adapted rolling 6 design. Starting dose \</= dose inducing Grade 2 toxicity in patients with solid tumors. RO6839921 will be given on Days 1-5 of 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity or study discontinuation.

Cohort 0

Group Type EXPERIMENTAL

RO6839921

Intervention Type DRUG

Non-escalating IV doses given on Days 1-5 of Cycle 1.

Solid tumor patients

Group Type EXPERIMENTAL

RO6839921

Intervention Type DRUG

Escalating IV doses of RO6839921 in solid tumor patients. Dose escalation will be calculated using the new Continual Reassessment Method (nCRM). RO6839921 will be given on Days 1-5 of 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity or study discontinuation.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RO6839921

Non-escalating IV doses given on Days 1-5 of Cycle 1.

Intervention Type DRUG

RO6839921

Escalating IV doses of RO6839921 in solid tumor patients. Dose escalation will be calculated using the new Continual Reassessment Method (nCRM). RO6839921 will be given on Days 1-5 of 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity or study discontinuation.

Intervention Type DRUG

RO6839921

Escalating IV doses of RO6839921 in AML patients. Escalation will follow an adapted rolling 6 design. Starting dose \</= dose inducing Grade 2 toxicity in patients with solid tumors. RO6839921 will be given on Days 1-5 of 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity or study discontinuation.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Cohort 0 and Arm A

* Patient must have histologically or cytologically confirmed advanced cancer for which standard cures or relieving measures either do not exist, are ineffective or are not acceptable to the patient.
* Measureable disease according to RECIST criteria version 1.1.
* ECOG performance status of 0 to 1.
* Adequate bone marrow function.

Arm B

* Patients with documented acute myeloid leukemia (AML), except for acute promyelocytic leukemia.
* Patients with relapsed/refractory AML or patients who have not received prior therapy who are high risk according to European LeukemiaNet (ELN) criteria.
* ECOG performance status of 0 to 2.

For Cohort 0, Arms A and B

* Life expectancy of \>/= 12 weeks.
* Age \>/= 18 years or older.
* All patients must be willing to use effective methods of contraception until 10 days after the last dose; women must not be pregnant or breast-feeding.
* Adequate renal and hepatic function.
* Patients with stable central nervous system (CNS) tumors are eligible.
* There are no requirements or limitations on the amount or type of prior anti-tumor/anti-leukemia therapy.

Exclusion Criteria

Cohort 0 and Arm A

* Patients with a history of any form of leukemia except for Stage 0 and 1 chronic lymphocytic leukemia (CLL) not requiring treatment.
* Patients receiving any cancer treatment within 21 days of start of study medication. Patients must also have recovered from severe side effects due to prior treatment before study start.
* Patients with known bone marrow disorders that may interfere with bone marrow recovery, or patients with delayed recovery from prior chemoradiotherapy.
* Patients with known bleeding or clotting disorders or non-drug-induced low platelet count.

Arm B

\- Patients receiving any cancer treatment within 14 days of start of study medication. Hydroxyurea may be taken until first administration of the study drug. Patients must also have recovered from severe side effects due to prior treatment before study start.

For Cohort 0, Arms A and B

* Patients receiving any other test drugs within 30 days of start of study medication
* Patients receiving the cytochrome P450 inhibitors, substrates or inducers specified in the protocol.
* Anticoagulation or antiplatelet treatment must be discontinued 7 days prior to start of study medication.
* Patients who have received hormonal therapy (except for prostate cancer treatment and hormone replacement therapy) within the 2 weeks prior to start of study medication.
* Patients with evidence of electrolyte imbalance, which may be treated to meet eligibility.
* Serum albumin \< 2.8 g/dL.
* HIV-positive patients who are currently receiving combination antiretroviral therapy.
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No