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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02577458
Other study ID # CM082-CA-I-103
Secondary ID
Status Recruiting
Phase Phase 1
First received October 12, 2015
Last updated January 8, 2018
Start date September 2015
Est. completion date June 2018

Study information

Verified date January 2018
Source AnewPharma
Contact Donghua Liu, M.D
Phone 21-50790731
Email dhliu@anewpharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date June 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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

- Ability to understand the nature of this trial and give written informed consent

Exclusion Criteria:

- 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

Study Design


Intervention

Drug:
CM082
CM082 tablets taken orally once a day on 28-day cycles
Everolimus
Everolimus tablets taken orally once a day on 28-day cycles

Locations

Country Name City State
China Beijing Cancer Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
AnewPharma Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose To determine the Maximum Tolerated Dose of the Combination in Chinese RCC Patients 12 months
Secondary Pharmacokinetics assessed by area under the plasma concentration versus time curve (AUC) of CM082 and everolimus 12 months
Secondary Objective response rate Objective response rate (ORR) 18 months
Secondary Progress free survival Progress free survival (PFS) 24 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03634540 - A Trial of Belzutifan (PT2977, MK-6482) in Combination With Cabozantinib in Patients With Clear Cell Renal Cell Carcinoma (ccRCC) (MK-6482-003) Phase 2
Active, not recruiting NCT02974738 - A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001) Phase 1