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Renal Cell Cancer MetastaticPhase 3NCT03095040

CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma

A Phase 3 study testing CM082 combined with everolimus, CM082 and Everolimus in people with Renal Cell Cancer Metastatic, run by AnewPharma at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This randomized, double blind, phase 2/3 study is aimed to evaluate the efficacy and safety of CM082 in combination with everolimus in Chinese patients with advanced renal cell carcinoma. The primary endpoint is progression-free survival. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Renal Cell Cancer Metastatic
What is being tested?
CM082 combined with everolimus, CM082 and Everolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
390 participants
Where
1 siteChina
Study dates
16 Dec 2016to Dec 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma
  • Progressed on at least one standard therapy with VEGFR TKI
  • Measurable disease per Recist v1.1
  • Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
  • Life expectancy of at least 12 weeks
  • Adequate organ functions, and meet the following requirements:
Show all 9Show fewer
  • Bone marrow: ANC ≥1.5109/L (1500/mm3), platelet ≥100109/L, and hemoglobin ≥9 g/dL Liver: 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 Kidney: Creatinine ≤ 1.25 x ULN, urine protein <1+ Heart: LVEF ≥ 50%
  • Willingness and ability to comply with trial and follow-up procedures
  • Ability to understand the nature of this trial and give written informed consent

Who cannot join

  • Currently receiving anti-cancer treatment; currently or previously have received 2 or more systemic anti-cancer treatment
  • Other tumors in addition to renal cell carcinoma
  • Females who are pregnant or breastfeeding
  • Known hypersensitivities to CM082 or everolimus
  • 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
Show all 9Show fewer
  • Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082 or everolimus
  • Any active infection
  • Drug or alcohol abuser

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: The Efficacy and Safety of CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma: a Randomized, Double-blind, Double Dummy, Multicenter Study

This randomized, double blind, phase 2/3 study is aimed to evaluate the efficacy and safety of CM082 in combination with everolimus in Chinese patients with advanced renal cell carcinoma. The primary endpoint is progression-free survival.

Being tested
CM082 combined with everolimus, CM082, Everolimus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CM082 combined with everolimusDrug

    Also called X-82, Affinitor

    CM082 tablets (200 mg, 2 tablets) taken orally once a day on 28-day cycles, everolimus tablets (10 mg, 2 tablets) taken orally once a day on 28-day cycles

  • CM082Drug

    Also called X-82

    CM082 tablets (200 mg, 2 tablets) taken orally once a day on 28-day cycles, dummy tablets for everolimus (2 tablets) taken orally once a day on 28-day cycles

  • EverolimusDrug

    Also called Affinitor

    Everolimus tablets (10 mg, 2 tablets) taken orally once a day on 28-day cycles, dummy tablets for CM082 (2 tablets) taken orally once a day on 28-day cycles

Study groups in NCT03095040
Study groupRoleWhat they receive
CM082 combined with everolimusExperimentalNot described
Receives: Drug: CM082 combined with everolimus
CM082ExperimentalNot described
Receives: Drug: CM082
EverolimusActive comparatorNot described
Receives: Drug: Everolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    The internal between the date of randomization and the date of disease progression, unaccepted toxicity, or death

    Measured: 12 months

Secondary outcomes (2)

  1. Overall survival

    The internal between the date of randomization and the date of death

    Measured: 36 months

  2. Objective response rate

    The percentage of patients with tumor response in overall population

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2017
  2. Study start16 Dec 2016
  3. Primary completionFeb 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
390 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03095040
Sponsor's protocol ID
CM082-CA-Ⅱ-201
Status last verified
Feb 2021
First submitted
23 Mar 2017
Last updated
8 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sheng X, Ye D, Zhou A, Yao X, Luo H, He Z, Wang Z, Zhao Y, Ji Z, Zou Q, He C, Guo J, Tu X, Liu Z, Shi B, Liu B, Chen P, Wei Q, Hu Z, Zhang Y, Jiang K, Zhou F, Wu D, Fu C, Li X, Wu B, Wang L, Qin S, Li G, Liu Y, Guo H, Chen K, Zhang D, Wang G, Ding L, Wang Y, Yuan X, Guo J. Efficacy and safety of vorolanib plus everolimus in metastatic renal cell carcinoma: A three-arm, randomised, double-blind, multicentre phase III study (CONCEPT). Eur J Cancer. 2023 Jan;178:205-215. doi: 10.1016/j.ejca.2022.10.025. Epub 2022 Nov 1.

    PubMed 36459768

  • Sheng X, Yan X, Chi Z, Cui C, Si L, Tang B, Li S, Mao L, Lian B, Wang X, Bai X, Zhou L, Kong Y, Dai J, Ding L, Mao L, Guo J. Phase 1 trial of vorolanib (CM082) in combination with everolimus in patients with advanced clear-cell renal cell carcinoma. EBioMedicine. 2020 May;55:102755. doi: 10.1016/j.ebiom.2020.102755. Epub 2020 Apr 23.

    PubMed 32335374

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CM082 combined with everolimus, CM082 and Everolimus in people with Renal Cell Cancer Metastatic, run by AnewPharma at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03095040, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.

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