Clinical trial · Interventional
Effect of Different Doses of AMG 706 on the Gallbladder in Advanced Solid Tumors
An Open-Label, Randomized, Phase 1b Study Evaluating the Effect of Different Doses of AMG 706 on the Gallbladder in Subjects With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study involves the use of three different dosing regimens of AMG 706 in patients with advanced solid tumors to see how the drug affects the gallbladder size and function. The study will be conducted in 11 sites in the US and Australia. A total of 48 patients will be enrolled in the study with the possibility of enrolling 8 more in each treatment arm.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 706 | Drug | Motesanib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Arm C
- description
- Arm C - AMG 706 75 mg BID 5-days on and 2-days off
- interventionNames
- Drug: AMG 706
- type
- OTHER
- label
- Arm B
- description
- Arm B - AMG 706 75 mg BID 2-weeks on and 1-week off
- interventionNames
- Drug: AMG 706
- type
- OTHER
- label
- Arm A
- description
- Arm A = AMG 706 125 mg PO daily continuously
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed advanced metastatic solid tumor * Ineligible to receive or progressed on standard of care therapies * Measurable or non-measurable disease per modified RECIST * Gallbladder must be in situ on screening ultrasound * ECOG Performance Status of 0 to 2 * Life expectancy of 6 months or more as determined by the investigator * Adequate organ and hematologic function as evidenced by laboratory studies prior to randomization * Men and women 18 years or older Exclusion Criteria: * Uncontrolled CNS metastases * Known history of prior cholecystitis, prior biliary procedure or prior or ongoing biliary disease * Radiation therapy within 14 days prior to randomization * Peripheral neuropathy \> Grade 1 per CTC AE v.3 * Currently or previously treated with AMG 706 or other VEGF inhibitors such as SU11248 (sunitinib), PTK787 (vatalanib), AZD2171, BAY 43-9006 (sorafenib), ZD6474 (vandetanib) * Previous treatment with bevacizumab is allowed if at least 6 weeks have elapsed from the last dose of bevacizumab to the date of randomization * Any anti-coagulant therapy within 7 days prior to randomization; low dose heparin and warfarin for prophylaxis against central venous catheter thrombosis is allowed * Less than 30 days have elapsed since participation in an investigational drug/device study or currently receiving investigational treatments * History of arterial or venous thrombosis within 1 year prior to randomization * History of bleeding diathesis or bleeding within 14 days of randomization * MI, CVA, TIA, PTCA/stent, CHF, Grade 2 or greater PVD, uncontrolled arrhythmias or unstable angina within one year prior to randomization * Uncontrolled HTN defined by a resting BP of \>150/90 mmHg * Surgery: major surgical procedure within 4 weeks or 28 days prior to randomization; minor surgical procedure, placement of access device or fine needle aspiration within 7 days of randomization; planned elective surgery while on study * Non-healing or open wound, ulcer or fracture * Known ongoing or active infection * Known (+) for HIV, Hep C or Hep B surface antigen * Known chronic hepatitis * Known history of allergy or hypersensitivity to AMG 706 or any of its components * Pregnant, ie, (+) b-HCG; breastfeeding
References
Publications (1)
- DERIVEDRosen LS, Lipton L, Price TJ, Belman ND, Boccia RV, Hurwitz HI, Stephenson JJ Jr, Wirth LJ, McCoy S, Hei YJ, Hsu CP, Tebbutt NC. The effect of different dosing regimens of motesanib on the gallbladder: a randomized phase 1b study in patients with advanced solid tumors. BMC Cancer. 2013 May 16;13:242. doi: 10.1186/1471-2407-13-242. PMID 23679351