Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer CLL DLBCL Follicular Lymphoma Head and Neck Cancer Malignancy Mantle Cell Lymphoma Multiple Myeloma Non-hodgkin Lymphoma Ovarian Cancer Pancreatic Cancer Small Cell Lung Cancer Soft Tissue Sarcoma Squamous Cell Carcinoma of Head and Neck Triple Negative Breast Cancer

Keywords

Oral MCT-inhibitor; refractory; B-cell; solid tumorcancer

Outcome Measures

Primary Outcomes (5)

Part A: Incidence of dose limiting toxicity
Cycle 1 Dose limiting toxicities and determination of the maximum tolerated dose
28 Days
Part B: Objective response rate
clinical benefit as determined by investigator assessments of tumor response
24 Weeks
Part C: Incidence of dose limiting toxicity
Cycle 1 Dose limiting toxicities and determination of the maximum tolerated dose in combination with rituximab and bendamustine
28 Days

Study Arms (5)

CYT-0851 dose escalation

EXPERIMENTAL

Part A: CYT-0851 administered orally in rising doses QD or BID for 28 day cycles

Drug: CYT-0851

CYT-0851 dose expansion

EXPERIMENTAL

Part B: CYT-0851 administered orally at the selected Phase 2 dose for 28 day cycles

Drug: CYT-0851

CYT-0851 and rituximab and bendamustine

EXPERIMENTAL

Part C: Daily oral doses of CYT-0851 for 28 days in combination with rituximab on Day 1 and bendamustine on Days 1 and 2 of each 28 day cycle

Interventions

CYT-0851Drug

Part A and B: Daily oral doses of CYT-0851 for 28 day cycles

CYT-0851 and capecitabineCYT-0851 and gemcitabineCYT-0851 and rituximab and bendamustineCYT-0851 dose escalationCYT-0851 dose expansion

CYT-0851 in combination with gemcitabineDrug

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Treatment programme
CYT-0851 in combination with gemcitabine
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry record
Treatment programme
CYT-0851 in combination with capecitabine
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry record
Grouped treatment entry
CYT-0851 in combination with rituximab and bendamustine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female ≥18 years of age at time of informed consent.
Female subjects of childbearing potential must be non-lactating, not pregnant as confirmed by a negative serum pregnancy test at most 30 days before enrollment and within 72 hours before the first administration of CYT-0851

Sponsors & Collaborators

Cyteir Therapeutics, Inc.
Industrylead

Study Sites (16)

University of California San Francisco

San Francisco, California, 94158, United States

Stanford Comprehensive Cancer Center

Stanford, California, 94305, United States

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Florida Cancer Specialists and Research Institute

Sarasota, Florida, 34232, United States

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

University of Michigan

MeSH Terms

Conditions

NeoplasmsLymphoma, Non-HodgkinMultiple MyelomaBreast NeoplasmsOvarian NeoplasmsSarcomaHead and Neck NeoplasmsLymphoma, Mantle-CellLymphoma, FollicularPancreatic NeoplasmsSmall Cell Lung CarcinomaSquamous Cell Carcinoma of Head and NeckTriple Negative Breast Neoplasms

Interventions

GemcitabineCapecitabineRituximab

Study Officials

Markus Renschler, MD
Cyteir Therapeutics
STUDY DIRECTOR

Enrollment

169 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 24, 2019

First Posted

June 25, 2019

Study Start

October 9, 2019

Actual (reported)

A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Study Arms (5)

CYT-0851 dose escalation

CYT-0851 dose expansion

CYT-0851 and rituximab and bendamustine

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (16)

MeSH Terms

Conditions

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (18)

CYT-0851 and gemcitabine

CYT-0851 and capecitabine

You may not qualify if:

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (5)

Study Arms (5)

CYT-0851 dose escalation

CYT-0851 dose expansion

CYT-0851 and rituximab and bendamustine

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (16)

MeSH Terms

Conditions

Interventions

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (18)

CYT-0851 and gemcitabine

CYT-0851 and capecitabine

You may not qualify if:

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations