Clinical trial NCT01863485: Phase 1 Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China
Official title: Phase 1 Safety, Tolerability, and Pharmacokinetic Study of CM082 (X-82) Tablets in Advanced Cancer Patients in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: advanced cancer
Lead sponsor: AnewPharma
Sponsor class: INDUSTRY
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2013-05-29
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Preliminary biological activity
timeFrame: 24 months
measure: Area Under Curve
timeFrame: 2 months
measure: Half-life time
timeFrame: 2 months
measure: Cmax
timeFrame: 2 months
measure: Tmax
timeFrame: 2 months
Locations:
city: Beijing
country: China
facility: Beijing University First Hospital
state: Beijing
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Tianjin
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing
name: Jin-Wan Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: