Trials Sponsors Conditions Drugs Pricing

Conditions

Advanced Solid Tumor Anal Cancer

Keywords

Sumitomo Pharma OncologyPhase 1Advanced Solid TumorsRefractoryAnal cancer

Outcome Measures

Primary Outcomes (3)

Determine maximum tolerated dose (MTD)
MTD will be determined based upon toxicity grades which are defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
50 months
Determine recommended Ph2 dose (RP2D) of TP-1454
To establish the RP2D for future studies with TP-1454. MTD, PK and PD data to be reviewed.
50 months
Incidence of SAEs and AEs resulting in study discontinuation, as assessed by NCI NTCAE v5.0
With approval of protocol amendment 7, the primary objective of this study is to continue to monitor the safety and tolerability of TP-1454 in ongoing patients.
From date of treatment through 30 days after End of Treatment, an average of 6 months

Secondary Outcomes (2)

Determine incidence of dose-limiting toxicities (DLTs)
28 days
Determine antitumor activity of TP-1454.
50 months

Study Arms (1)

TP-1454

EXPERIMENTAL

Flat dose once or twice daily

Drug: TP-1454 monotherapy

Interventions

TP-1454 monotherapyDrug

Flat dose once or twice daily, alone

TP-1454

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patients to be enrolled during Dose Escalation with capsules must have a histologically confirmed diagnosis of advanced metastatic or progressive solid tumor who are refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition (enrollment complete).
Following approval of Amendment 5.0, patients to be enrolled during Dose Escalation with Tablets must have a histologically confirmed diagnosis of anal cancer and:

Sponsors & Collaborators

Sumitomo Pharma America, Inc.
Industrylead

Study Sites (11)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

University of Southern California - Norris Cancer Center and Hoag Memorial Hospital

Los Angeles, California, 90033 and 92663, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Comprehensive Cancer Center of Nevada

Las Vegas, Nevada, 89169, United States

Vanderbilt University

Nashville, Tennessee, 37232, United States

Texas Oncology Baylor Sammons Cancer Center

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Study Officials

Jian Li, MD
Sumitomo Pharma America, Inc.
STUDY DIRECTOR

Enrollment

31 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

March 20, 2020

First Posted

March 31, 2020

Study Start

July 8, 2020

Actual (reported)

Phase 1 Study of Oral TP-1454

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (1)

TP-1454

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

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 (3)

Secondary Outcomes (2)

Study Arms (1)

TP-1454

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations