NCT02577458

UnknownPhase 1

Study of the Combination of CM082 With Everolimus in Patient...

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Other study identifiers

Sponsor study identifier

CM082-CA-I-103

Study Type

interventional

Estimated enrollment

18

Locations

1 country

Sites

1

Timeline

Study Start

September 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2018

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 2018

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief Summary

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in Chinese Patients With Advanced Renal Cell Carcinoma.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 18 participants
Study completion date: June 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2015
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 12, 2015
Actual (reported)
First Posted
October 16, 2015
Actual (reported)
Primary Completion
March 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2018
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: January 10, 2018
Status Verified: January 2018
Last Update Submitted: January 8, 2018

Conditions

Renal Cell Carcinoma Recurrent

Outcome Measures

Primary Outcomes (1)

Maximum Tolerated Dose
To determine the Maximum Tolerated Dose of the Combination in Chinese RCC Patients
12 months

Secondary Outcomes (3)

Pharmacokinetics assessed by area under the plasma concentration versus time curve (AUC) of CM082 and everolimus
12 months
Objective response rate
18 months
Progress free survival
24 months

Study Arms (1)

CM082 plus everolimus

EXPERIMENTAL

CM082 plus everolimus

Drug: CM082Drug: Everolimus

Interventions

CM082Drug

CM082 tablets taken orally once a day on 28-day cycles

Also known as: X-82

CM082 plus everolimus

EverolimusDrug

Everolimus tablets taken orally once a day on 28-day cycles

Also known as: Affinitor

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma
Progressed on at least one standard therapy

Sponsors & Collaborators

Peking University Cancer Hospital & Institute
Othercollaborator
AnewPharma
Industrylead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Xinan Sheng, M.DCONTACT010-88196951 doctor_sheng@126.com

MeSH Terms

Interventions

vorolanibEverolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

Jun Guo, M.D
Peking University Cancer Hospital & Institute
STUDY CHAIR
Xinan Sheng, M.D
Peking University Cancer Hospital & Institute
PRINCIPAL INVESTIGATOR

Central Study Contacts

Donghua Liu, M.D

CONTACT

21-50790731 dhliu@anewpharma.com

Yan He, M.D

CONTACT

18280417935

Study Design

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

Study Record Dates

First Submitted

October 12, 2015

First Posted

October 16, 2015

Study Start

September 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2018

Estimated (date passed)

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Safety and Efficacy of RAD001 in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor

Phase 1Completed

NCT01152801

Safety of RAD001 in Chinese Patients With Metastatic Renal Cell Cancer

Phase 1Completed

NCT03710863

Safety and Tolerability of Oral CM082 in Patients With wAMD

Phase 2Unknown

NCT00968591

Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency

Phase 1Completed

NCT02138929

LDE225 + Everolimus in Advanced Gastroesophageal Adenocarcinoma

Phase 1Completed

NCT01217177

A Study of mTOR Inhibitor Everolimus (RAD001) in Association With Cisplatin and Radiotherapy for Locally Advanced Cervix Cancer

Phase 1Completed

CM082 plus everolimus

Measurable disease per Recist1.1

Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1

Life expectancy of at least 12 weeks

No abnormal bone marrow function

Adequate heart, lung, liver, kidney organ system functions, and meet the following requirements:

Total bilirubin ≤1.5 times the upper limit of normal (ULN)

Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5x the upper limit of normal (ULN) if no liver involvement or ≤5x the upper limit of normal with liver involvement.

Creatinine ≤ 1.5 x ULN

Urine protein \<1+

QTcF \< 450 ms

LVEF ≥ 50%

At least 4 weeks after receiving cancer therapy (i.e., chemotherapy, radiation therapy, biologic therapy, hormonal therapy); 3 months after surgery and recovered

Willingness and ability to comply with trial and follow-up procedures

+1 more criteria

You may not qualify if:

Currently receiving anti-cancer treatment
Other tumors in addition to renal cell carcinoma
Have taken strong cytochrome P450 3A4 inhibitors or inducers in the last 2 weeks
Concomitant use of drugs with a risk of causing prolonged corrected QT interval and/or Torsades de Pointes
Patients with a history of intolerance to, or significant toxicity with VEGFR tyrosine kinase inhibitor(s) (TKI) or everolimus
Females who are pregnant or breastfeeding
Those in reproductive ages who refuse to use contraception
Those with concurrent condition(e.g. psychological, neuronal, cardiovascular, respiratory conditions or infections) that in the investigator's opinion would jeopardize compliance with the protocol
Patients with known central nervous system (CNS) metastases
Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082 or everolimus
Patients with known severe lung disorders such as asthma, chronic obstructive pulmonary disease (COPD)
Patients who are HIV positive
Drug or alcohol abuser

Contact the study team to confirm eligibility.

yhe@anewpharma.com

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 2018

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

January 10, 2018

Record last verified: 2018-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02577458
Data provider: ClinicalTrials.gov
Source updated: 2018-01-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:32 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (1)

CM082 plus everolimus

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations