Phase 1 Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China

Advanced Cancer Clinical Trial

Official title:

Phase 1 Safety, Tolerability, and Pharmacokinetic Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863485
• Other study ID #: CM082-CA-I-001
• Secondary ID: 2013L00579?2013L
• Status: Completed
• Phase: Phase 1
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: July 2019
• Source: AnewPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors.

Description:

This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CM082 tablets in Chinese Patients With Advanced Solid Tumors. After the maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion cohort of ~20 advanced renal cell carcinoma patients will be enrolled to further characterize the safety and tumor response by CT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no effective therapy.

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

• Life expectancy of at least 12 weeks.

• No immuno deficiency.

• Adequate organ system function, defined as follows:

• Absolute neutrophil count (ANC) =1.5 x 10**9/L

• Platelets =100 x 10**9/L

• Hemoglobin =10 g/dL

• 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 =2.5x the upper limit of normal with liver involvement.

• Creatinine = 1.5 x ULN.

• At least 4 weeks or 5 half-life after receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization.

• 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:

• Not recovered from prior anti-cancer therapy or surgery.

• 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).

• 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 (X-82).

• Patients with known GI disorders such as vomiting, diarrhea.

• Patients who are hepatitis B virus positive.

• Drug abuser.

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Beijing University First Hospital	Beijing	Beijing
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing
China	Tianjin Cancer Hospital	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
AnewPharma	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Preliminary biological activity	clinical tumor response by computed tomography (CT) after treatment with CM082 tablets given as a single agent.	24 months
Other	Area Under Curve		2 months
Other	Half-life time		2 months
Other	Cmax	Peak concentration	2 months
Other	Tmax	Time to Cmax	2 months
Primary	Maximum Tolerated Dose	To determine the Maximum Tolerated Dose in Chinese patients with advanced solid tumors.	12 months