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Renal Cell Carcinoma RecurrentPhase 1NCT02577458

Study of the Combination of CM082 With Everolimus in Patients With mRCC

A Phase 1 study testing CM082 and Everolimus in people with Renal Cell Carcinoma Recurrent, 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 The sponsor has not verified this record for over two years, so it may be out of date.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 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Renal Cell Carcinoma Recurrent
What is being tested?
CM082 and Everolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
Sep 2015to Jun 2018
Phase
Phase 1
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 70 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
  • 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
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  • 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
  • Ability to understand the nature of this trial and give written informed consent

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Donghua Liu, M.D contact

21-50790731

dhliu@anewpharma.com

Yan He, M.D contact

18280417935

yhe@anewpharma.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Xinan Sheng, M.D, 010-88196951, doctor_sheng@126.com

    Recruiting

Other trials in China

About this study

Official title: Phase 1 Study of the Combination of CM082 With Everolimus in Patients With Metastatic Renal Cell Carcinoma (RCC): Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy

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.

Read the detailed description

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 Renal Cell Carcinoma (RCC). After the maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion cohort of ~10 advanced renal cell carcinoma patients will be enrolled to further characterize the safety and tumor response by CT.

Being tested
CM082, Everolimus

What participants receive

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

  • CM082Drug

    Also called X-82

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

  • EverolimusDrug

    Also called Affinitor

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

Study groups in NCT02577458
Study groupRoleWhat they receive
CM082 plus everolimusExperimentalCM082 plus everolimus
Receives: Drug: CM082; Drug: Everolimus

What is being measured

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

  1. Maximum Tolerated Dose

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

    Measured: 12 months

Secondary outcomes (3)

  1. Pharmacokinetics assessed by area under the plasma concentration versus time curve (AUC) of CM082 and everolimus

    Measured: 12 months

  2. Objective response rate

    Objective response rate (ORR)

    Measured: 18 months

  3. Progress free survival

    Progress free survival (PFS)

    Measured: 24 months

Timeline

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

  1. First posted16 Oct 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionMar 2018 (estimated)
  4. Study completionJun 2018 (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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02577458
Sponsor's protocol ID
CM082-CA-I-103
Status last verified
Jan 2018
First submitted
12 Oct 2015
Last updated
10 Jan 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CM082 and Everolimus in people with Renal Cell Carcinoma Recurrent, 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 16 inclusion and 13 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 10 Jan 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Donghua Liu, M.D (21-50790731, dhliu@anewpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (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 NCT02577458.

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 10 Jan 2018.

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