NCT02577458

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

2.5 years

First QC Date

October 12, 2015

Last Update Submit

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
CM082 plus everolimus

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
  • 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.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

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

21-50790731dhliu@anewpharma.com

Yan He, M.D

CONTACT

18280417935yhe@anewpharma.com

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 1, 2015

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

January 10, 2018

Record last verified: 2018-01

Locations

CN(1)